Bio

Curriculum vitae

Professor Qureshi is an Associate Professor, Department of Obstetrics and Gynaecology, University of Nairobi. She is the immediate former Head of Department of Obstetrics and Gynaecology. She has interests in safe motherhood, management of pregnancy complications and postpartum bleeding.

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Publications


Submitted

Qureshi, ZP.  Submitted.  Case Records and Commentaries.

2020

Collaborators, TWHOACTIONT.  2020.  Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries. New England Medical Journal. 382(17) AbstractWebsite

Abstract

Background: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.

Methods: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.

Results: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P=0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P=0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events.

Conclusions: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection.

Mitchell, EJ, Qureshi ZP, Were F, Daniels J, Gwako G, Osoti A, Opira J, Bradshaw L, Oliver M, Pallotti P, Ojha S.  2020.  Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: results of a mixed-methods study at a national referral hospital in Kenya. BMJ Open. 10(10) AbstractWebsite

Abstract

Introduction: Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month of life are due to prematurity and the neonatal mortality rate is eight times higher in low-income and middle-income countries (LMICs) than in Europe. Early Warning Scores (EWS) are a way of recording vital signs using standardised charts to easily identify adverse clinical signs and escalate care appropriately. A range of EWS have been developed for neonates, though none in LMICs. This paper reports the findings of early work to examine if the use of EWS is feasible in LMICs.

Methods: We conducted an observational study to understand current practices for monitoring of preterm infants at a large national referral hospital in Nairobi, Kenya. Using hospital records, data were collected over an 8-week period in 2019 on all live born infants born at <37 weeks and/or <2500 g (n=294, 255 mothers) in the first week of life. Using a chart adopted from the EWS developed by the British Association of Perinatal Medicine, we plotted infants' vital signs. In addition, we held group discussions with stakeholders in Kenya to examine opinions on use of EWS.

Results: Recording of vital signs was variable; only 63% of infants had at least one temperature recorded and 53% had at least one heart rate and respiratory rate recorded. Stakeholders liked the traffic-light system and simplicity of the chart, though recognised challenges, such as staffing levels and ability to print in colour, to its adoption.

Conclusion: EWS may standardise documentation and identify infants who are at higher risk of an adverse outcome. However, human and non-human resource issues would need to be explored further before development of an EWS for LMICs.

Brizuela, V, Bonet M, Romero CLT, Abalos E, Baguiya A, Fawole B, Knight M, Lumbiganon P, Minkauskienė M, Nabhan A, Osman NB, Qureshi ZP, Souza JP.  2020.  Early evaluation of the ‘STOP SEPSIS!’ WHO Global Maternal Sepsis Awareness Campaign implemented for healthcare providers in 46 low, middle and high-income countries. British Medical Journal . 10(5) AbstractWebsite

Objective To evaluate changes in awareness of maternal sepsis among healthcare providers resulting from the WHO Global Maternal Sepsis Study (GLOSS) awareness campaign.

Design Independent sample precampaign/postcampaign through online and paper-based surveys available for over 30 days before campaign roll-out (pre) and after study data collection (post). Descriptive statistics were used for campaign recognition and exposure, and odds ratio (OR) and percentage change were calculated for differences in awareness, adjusting for confounders using multivariate logistic regression.

Setting and participants Healthcare providers from 398 participating facilities in 46 low, middle and high-income countries.

Intervention An awareness campaign to accompany GLOSS launched 3 weeks prior to data collection and lasting the entire study period (28 November 2017 to 15 January 2018) and beyond.

Main outcome measures Campaign recognition and exposure, and changes in awareness.

Results A total of 2188 surveys were analysed: 1155 at baseline and 1033 at postcampaign. Most survey respondents found the campaign materials helpful (94%), that they helped increase awareness (90%) and that they helped motivate to act differently (88%). There were significant changes with regard to: not having heard of maternal sepsis (−63.4% change, pre-OR/post-OR 0.35, 95% CI 0.18 to 0.68) and perception of confidence in making the right decisions with regard to maternal sepsis identification and management (7.3% change, pre-OR/post-OR 1.44, 95% CI 1.01 to 2.06).

Conclusions Awareness raising campaigns can contribute to an increase in having heard of maternal sepsis and an increase in provider perception of confidence in making correct decisions. Offering the information to make accurate and timely decisions while promoting environments that enable self-confidence and support could improve maternal sepsis identification and management.

Mitchell, EJ, Benjamin S, Ononge S, Ditai J, QURESHI ZAHIDA, Masood SN, Whitham D, Godolphin PJ, Duley L.  2020.  Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda. BMC Pregnancy Childbirth . 20(439) AbstractWebsite

Background
Globally, 15 million infants are born preterm each year, and 1 million die due to complications of prematurity. Over 60% of preterm births occur in Sub-Saharan Africa and south Asia. Care at birth for premature infants may be critical for survival and long term outcome. We conducted a prospective audit to assess whether women giving birth preterm could be identified, and to describe cord clamping and neonatal care at hospitals in Africa and south Asia.

Methods
This prospective audit of livebirths was conducted at six hospitals in Uganda, Kenya, India and Pakistan. Births were considered preterm if between 28+ 0 and 33+ 6 weeks gestation and/or the birthweight was 1.00 to 1.99 kg. A pre-specified audit plan was agreed with each hospital. Livebirths before 28 weeks gestation with birthweight less than 1.0 kg were excluded. Data were collected on estimated and actual gestation and birthweight, cord clamping, and neonatal care.

Results
Of 4149 women who gave birth during the audit, data were available for 3687 (90%). As 107 were multiple births, 3781 livebirths were included, of which 257 (7%) were preterm. Antenatal assessment correctly identified 148 infants as ‘preterm’ and 3429 as ‘term’, giving a positive predictive value of 72% and negative predictive value of 97%. For term births, cord clamping was usually later at the two Ugandan hospitals, median time to clamping 50 and 76 s, compared with 23 at Kenyatta (Kenya), 7 at CMC (India) and 12 at FBH/LNH (Pakistan). At the latter two, timing was similar between term and preterm births, and between vaginal and Caesarean births. For all the hospitals, the cord was clamped quickly at Caesarean births, with Mbale (Uganda) having the highest median time to clamping (15 s ‘term’, 19 ‘preterm’). For preterm infants temperature on admission to the neonatal unit was below 35.5 °C for 50%, and 59 (23%) died before hospital discharge.

Conclusions
Antenatal identification of preterm birth was good. Timing of cord clamping varied between hospitals, although at each there was no difference between ‘term’ and ‘preterm’ births. For premature infants hypothermia was common, and mortality before hospital discharge was high.

Bonet, M, Brizuela V, Abalos E, Cuesta C, Baguiya A, Group TWHOGMSS(GLOSS) R.  2020.  Frequency and management of maternal infection in health facilities in 52 countries: Results of the WHO Global Maternal Sepsis Study (GLOSS), a one-week inception cohort.. Lancet Global Health. . 8(5):661-671. AbstractWebsite

Background
Maternal infections are an important cause of maternal mortality and severe maternal morbidity. We report the main findings of the WHO Global Maternal Sepsis Study, which aimed to assess the frequency of maternal infections in health facilities, according to maternal characteristics and outcomes, and coverage of core practices for early identification and management.
Methods
We did a facility-based, prospective, 1-week inception cohort study in 713 health facilities providing obstetric, midwifery, or abortion care, or where women could be admitted because of complications of pregnancy, childbirth, post-partum, or post-abortion, in 52 low-income and middle-income countries (LMICs) and high-income countries (HICs). We obtained data from hospital records for all pregnant or recently pregnant women hospitalised with suspected or confirmed infection. We calculated ratios of infection and infection-related severe maternal outcomes (ie, death or near-miss) per 1000 livebirths and the proportion of intrahospital fatalities across country income groups, as well as the distribution of demographic, obstetric, clinical characteristics and outcomes, and coverage of a set of core practices for identification and management across infection severity groups.
Findings
Between Nov 28, 2017, and Dec 4, 2017, of 2965 women assessed for eligibility, 2850 pregnant or recently pregnant women with suspected or confirmed infection were included. 70·4 (95% CI 67·7–73·1) hospitalised women per 1000 livebirths had a maternal infection, and 10·9 (9·8–12·0) women per 1000 livebirths presented with infection-related (underlying or contributing cause) severe maternal outcomes. Highest ratios were observed in LMICs and the lowest in HICs. The proportion of intrahospital fatalities was 6·8% among women with severe maternal outcomes, with the highest proportion in low-income countries. Infection-related maternal deaths represented more than half of the intrahospital deaths. Around two-thirds (63·9%, n=1821) of the women had a complete set of vital signs recorded, or received antimicrobials the day of suspicion or diagnosis of the infection (70·2%, n=1875), without marked differences across severity groups.
Interpretation
The frequency of maternal infections requiring management in health facilities is high. Our results suggest that contribution of direct (obstetric) and indirect (non-obstetric) infections to overall maternal deaths is greater than previously thought. Improvement of early identification is urgently needed, as well as prompt management of women with infections in health facilities by implementing effective evidence-based practices.

2019

M, W, G P, GJ H, G C, A C, I G, S G, AM G, S LL, P L, K M.  2019.  Maternal characteristics and causes associated with refractory postpartum haemorrhage after vaginal birth: a secondary analysis of the WHO CHAMPION trial data. BJOG: An International Journal of Obstetrics & Gynaecology.. 127(5):628-634. AbstractWebsite

Objective: To assess the maternal characteristics and causes associated with refractory postpartum haemorrhage (PPH).

Design: Secondary analysis of the WHO CHAMPION trial data.

Setting: Twenty-three hospitals in ten countries.

Population: Women from the CHAMPION trial who received uterotonics as first-line treatment of PPH.

Methods: We assessed the association between sociodemographic, pregnancy and childbirth factors and refractory PPH, and compared the causes of PPH between women with refractory PPH and women responsive to first-line PPH treatment.

Main outcome measures: Maternal characteristics; causes of PPH.

Results: Women with labour induced or augmented with uterotonics (adjusted odds ratio [aOR] 1.35; 95% CI 1.07-1.72), with episiotomy or tears requiring suturing (aOR 1.82; 95% CI 1.34-2.48) and who had babies with birthweights ≥3500 g (aOR 1.33; 95% CI 1.04-1.69) showed significantly higher odds of refractory PPH compared with the reference categories in the multivariate analysis adjusted by centre and trial arm. While atony was the sole PPH cause in 53.2% (116/218) of the women in the responsive PPH group, it accounted for only 31.5% (45/143) of the causes in the refractory PPH group. Conversely, tears were the sole cause in 12.8% (28/218) and 28% (40/143) of the responsive PPH and refractory PPH groups, respectively. Placental problems were the sole cause in 11 and 5.6% in the responsive and refractory PPH groups, respectively.

Conclusion: Women with refractory PPH showed a different pattern of maternal characteristics and PPH causes compared with those with first-line treatment responsive PPH.

Collaborators, WHOACTIONT.  2019.  The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) . TRIALS. 20(1):507. AbstractWebsite

Background
Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries.

Methods/design
The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up).

Discussion
Findings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization’s global recommendations on ACS use.

P, G, H S, D M, L L, E B, T MD, L O, V W, C W, Z Q, E O, A G, R M.  2019.  Effectiveness of an Electronic Partogram: A Mixed-Method, Quasi- experimental Study.. Global Health: Science and Practice. 7(4):521-539. AbstractWebsite

Background: Timely identification and management of intrapartum complications could significantly reduce maternal deaths, intrapartum stillbirths, and newborn deaths due to hypoxia. The World Health Organization (WHO) identifies monitoring of labor using the paper partograph as a high-priority intervention for identifying abnormities in labor and fetal well-being. This article describes a mixed-method, quasi-experimental study to assess the effectiveness of an Android tablet-based electronic, labor clinical decision-support application (ePartogram) in limited-resource settings.

Methods: The study, conducted in Kenya from October 2016 to May 2017, allocated 12 hospitals and health centers to an intervention (ePartogram) or comparison (paper partograph) group. Skilled birth attendants (SBAs) in both groups received a 2-day refresher training in labor management and partograph use. The intervention group received an additional 1-day orientation on use and care of the Android-based ePartogram app. All outcomes except one compare post-ePartogram intervention versus paper partograph controls. The exception is outcome of early perinatal mortality pre- and post-ePartogram introduction in intervention sites compared to control sites. We used log binomial regression to analyze the primary outcome of the study, suboptimal fetal outcomes. We also analyzed for secondary outcomes (SBAs performing recommended actions), and conducted in-depth interviews with facility in-charges and SBAs to ascertain acceptability and adoptability of the ePartogram.

Results: We compared data from 842 clients in active labor using ePartograms with data from 1,042 clients monitored using a paper partograph. SBAs using ePartograms were more likely than those using paper partographs to take action to maintain normal labor, such as ambulation, feeding, and fluid intake, and to address abnormal measurements of fetal well-being (14.7% versus 5.3%, adjusted relative risk=4.00, 95% confidence interval [CI]=1.95–8.19). Use of the ePartogram was associated with a 56% (95% CI=27%–73%) lower likelihood of suboptimal fetal outcomes than the paper partograph. Users of the ePartogram were more likely to be compliant with routine labor observations. SBAs stated that the technology was easy to use but raised concerns about its use at high-volume sites. Further research is needed to evaluate costs and benefit and to incorporate recent WHO guidance on labor management.

Conclusion: ePartogram use was associated with improvements in adherence to recommendations for routine labor care and a reduction in adverse fetal outcomes, with providers reporting adoptability without undue effort. Continued development of the ePartogram, including incorporating new clinical rules from the 2018 WHO recommendations on intrapartum care, will improve labor monitoring and quality care at all health system levels.

P, G, H S, D M, L L, E B, T MD, L O, V W, C W, Z Q, E O, A G, R M.  2019.  Effectiveness of an Electronic Partogram: A Mixed-Method, Quasi- experimental Study.. Global Health: Science and Practice. 7(4):521-539. AbstractWebsite

Background: Timely identification and management of intrapartum complications could significantly reduce maternal deaths, intrapartum stillbirths, and newborn deaths due to hypoxia. The World Health Organization (WHO) identifies monitoring of labor using the paper partograph as a high-priority intervention for identifying abnormities in labor and fetal well-being. This article describes a mixed-method, quasi-experimental study to assess the effectiveness of an Android tablet-based electronic, labor clinical decision-support application (ePartogram) in limited-resource settings.

Methods: The study, conducted in Kenya from October 2016 to May 2017, allocated 12 hospitals and health centers to an intervention (ePartogram) or comparison (paper partograph) group. Skilled birth attendants (SBAs) in both groups received a 2-day refresher training in labor management and partograph use. The intervention group received an additional 1-day orientation on use and care of the Android-based ePartogram app. All outcomes except one compare post-ePartogram intervention versus paper partograph controls. The exception is outcome of early perinatal mortality pre- and post-ePartogram introduction in intervention sites compared to control sites. We used log binomial regression to analyze the primary outcome of the study, suboptimal fetal outcomes. We also analyzed for secondary outcomes (SBAs performing recommended actions), and conducted in-depth interviews with facility in-charges and SBAs to ascertain acceptability and adoptability of the ePartogram.

Results: We compared data from 842 clients in active labor using ePartograms with data from 1,042 clients monitored using a paper partograph. SBAs using ePartograms were more likely than those using paper partographs to take action to maintain normal labor, such as ambulation, feeding, and fluid intake, and to address abnormal measurements of fetal well-being (14.7% versus 5.3%, adjusted relative risk=4.00, 95% confidence interval [CI]=1.95–8.19). Use of the ePartogram was associated with a 56% (95% CI=27%–73%) lower likelihood of suboptimal fetal outcomes than the paper partograph. Users of the ePartogram were more likely to be compliant with routine labor observations. SBAs stated that the technology was easy to use but raised concerns about its use at high-volume sites. Further research is needed to evaluate costs and benefit and to incorporate recent WHO guidance on labor management.

Conclusion: ePartogram use was associated with improvements in adherence to recommendations for routine labor care and a reduction in adverse fetal outcomes, with providers reporting adoptability without undue effort. Continued development of the ePartogram, including incorporating new clinical rules from the 2018 WHO recommendations on intrapartum care, will improve labor monitoring and quality care at all health system levels.

Kivai, JM, KAYIMA JK, Were AO, Qureshi Z.  2019.  Foetal outcome in women with Pregnacy related Acute Kidney Injury in a referral facilty in Kenya . IOSR Journal of Dental and Medical Sciences. 18(11):52-56.Website
Thanh BY, P L, Pattanittum P, Laopaiboon M, JP V, Oladapo OT, Pileggi-Castro C, Mori R, Jayaratne K, Z Q, J S.  2019.  Mode of delivery and pregnancy outcomes in preterm birth: a secondary analysis of the WHO Global and Multi-country Surveys.. Scientific reports. 9(15556):1-8. AbstractWebsite

Many studies have been conducted to examine whether Caesarean Section (CS) or vaginal birth (VB) was optimal for better maternal and neonatal outcomes in preterm births. However, findings remain unclear. Therefore, this secondary analysis of World Health Organization Global Survey (GS) and Multi-country Survey (MCS) databases was conducted to investigate outcomes of preterm birth by mode of delivery. Our sample were women with singleton neonates (15,471 of 237 facilities from 21 countries in GS; and 15,053 of 239 facilities from 21 countries in MCS) delivered between 22 and <37 weeks of gestation. We assessed association between mode of delivery and pregnancy outcomes in singleton preterm births by multilevel logistic regression adjusted for hierarchical data. The prevalences of women with preterm birth delivered by CS were 31.0% and 36.7% in GS and MCS, respectively. Compared with VB, CS was associated with significantly increased odds of maternal intensive care unit admission, maternal near miss, and neonatal intensive care unit admission but significantly decreased odds of fresh stillbirth, and perinatal death. However, since the information on justification for mode of delivery (MOD) were not available, our results of the potential benefits and harms of CS should be carefully considered when deciding MOD in preterm births.

Subject terms: Epidemiology, Outcomes research

Ismail LW, ZP Q, SB O.  2019.  The acceptability of HIV testing among women receiving post abortion care. South Sudan Medical Journal. 12(3):101-105. AbstractWebsite

Introduction: In South Sudan few women have heard about the HIV. The prevalence of HIV infection in the country is 2.6%. Post abortion care (PAC) accounts for over 50% of all gynaecological admissions at the Juba Teaching Hospital (JTH). HIV testing is not routinely offered as part of PAC services.

Objective: To determine factors associated with acceptability of HIV testing among women receiving PAC at JTH.

Methods: This was a cross-sectional study, conducted at the Gynaecological Unit of JTH. Three hundred and forty patients were interviewed using a structured questionnaire.

Results: The mean age of the participants was 24.7 years with 50.5% aged <25years, 31.5% were employed, and 31.8% had no formal education. Acceptability of HIV testing was 70.9% and the prevalence of HIV was 2.7%. The most common reason for not accepting, was the belief, based on previous results, that they were HIV negative. Patients aged ≥25 years and those with primary and secondary education were twice as likely to accept HIV testing than those <25 years and those with no formal education, respectively. Employment status, religion and marital status were not statistically associated with acceptability of HIV testing. Patients previously tested for HIV were more likely to accept testing.

Conclusion: Routine HIV testing should be integrated into PAC services with efforts to increase awareness of HIV and importance of testing

Key words: HIV, abortion, post-abortion care, South Sudan

Kivai, JM, KAYIMA JK, Were AO, Qureshi Z.  2019.  Impact of Pregnancy Related Acute Kidney Injury on foetalsurvival: a single Centre Experience in Kenya.. IOSR Journal of Dental and Medical Sciences. 18(7):13-17.Website
Osoti AO, JP V, Oladapo OT, ZP Q, AM G.  2019.  Tranexamic acid for treatment of postpartum haemorrhage. Obstetrics, Gynaecology & Reproductive Medicine. 29(5):146-147. AbstractWebsite

Postpartum haemorrhage remains the leading cause of maternal mortality globally. Mortality and severe morbidity due to postpartum haemorrhage is highest in lower-resource settings. Tranexamic acid is an anti-fibrinolytic drug that has been in use in humans for nearly five decades. It is a structural analogue of lysine that binds irreversibly to plasminogen, thereby inhibiting the binding of plasmin to fibrin. This in turn inhibits fibrinolysis, thus stabilizing blood clots. Tranexamic acid has been shown to improve outcomes in trauma-related bleeding. New research has shown that early use of tranexamic acid (within 3 hours of birth), in addition to standard care, safely reduces deaths due to bleeding in women with clinically diagnosed postpartum haemorrhage, regardless of the mode of birth.

Keywords: anti-fibrinolysis,maternal mortality,postpartum haemorrhage,tranexamic acid

D, P, ZP Q, K L, MK K, GN G, Odawa FX, A O, O K, PK K, Kosgei RJ, AB K, PM N, O O.  2019.  Use of the Robson Classification to compare Caesarean Section patterns at the Kenyatta National Hospital after and before free Maternity Services in Kenya. Journal of Obstetrics and Gynaecology of East & Central Africa. 30(2):46-51.Website
Odhiambo SA, ZP Q, PM N, Kosgei RJ, AB K, Ayieko P, PK K, A O, Odawa FX, GN G, MK K, O K, O O.  2019.  Early Neonatal Outcomes among Mothers receiving variable doeses of Dexamethasone for Preterm Premature Rupture of Membranes at Kenyatta National Hospital: A restrospective Cohort Study . Journal of Obstetrics and Gynaecology of East & Central Africa. 30(2):54-61.Website
Odhiambo SA, ZP Q, PM N, Kosgei RJ, AB K, Ayieko P, PK K, A O, Odawa FX, GN G, MK K, O K, O O.  2019.  Born Too Soon: Provide Corticosteriods at the earliest opportunity even if dose is not completed. Journal of Obstetrics and Gynaecology of East & Central Africa. 30(2):62-63.Website
D, P, ZP Q, K L, MK K, GN G, Odawa FX, A O, O K, PK K, Kosgei RJ, AB K, PM N, O O.  2019.  Policy Brief - Increasing Caesarean Section rates among low risk women after introduction of free maternity services in a Kenyan National Referral Hospital. Journal of Obstetrics and Gynaecology of East & Central Africa. 30(2):52-53.Website
Obimbo MM, Y Z, MT MM, CR C, Z Q, J O’ech, JA O’o, SJ F.  2019.  Placental Structure in Preterm Birth Among HIV-Positive Versus HIV-Negative Women in Kenya. Journal of Acquired Immune Deficiency Syndromes. 80(1):94-102. AbstractWebsite

Background: Preterm birth (PTB) is a major cause of infant morbidity and mortality in developing countries. Recent data suggest that in addition to Human Immunodeficiency Virus (HIV) infection, use of antiretroviral therapy (ART) increases the risk of PTB. As the mechanisms remain unexplored, we conducted this study to determine whether HIV and ART were associated with placental changes that could contribute to PTB.

Setting: We collected and evaluated placentas from 38 HIV-positive women on ART and 43 HIV-negative women who had preterm deliveries in Nairobi, Kenya.

Methods: Anatomical features of the placentas were examined at gross and microscopic levels. Cases were matched for gestational age and compared by the investigators who were blinded to maternal HIV serostatus.

Results: Among preterm placentas, HIV infection was significantly associated with thrombosis (P = 0.001), infarction (P = 0.032), anomalies in cord insertion (P = 0.02), gross evidence of membrane infection (P = 0.043), and reduced placental thickness (P = 0.010). Overall, preterm placentas in both groups were associated with immature villi, syncytial knotting, villitis, and deciduitis. Features of HIV-positive versus HIV-negative placentas included significant fibrinoid deposition with villus degeneration, syncytiotrophoblast delamination, red blood cell adhesion, hypervascularity, and reduction in both surface area and perimeter of the terminal villi.

Conclusions: These results imply that HIV infection and/or ART are associated with morphological changes in preterm placentas that contribute to delivery before 37 weeks. Hypervascularity suggests that the observed pathologies may be attributable, in part, to hypoxia. Further research to explore potential mechanisms will help elucidate the pathways that are involved perhaps pointing to interventions for decreasing the risk of prematurity among HIV-positive women.

2018

Group, WHOODR.  2018.  Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study . Reproductive Health . 15(45) AbstractWebsite

Background
A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study.

Methods
Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device.

Results
Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads.

Conclusions
Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial.

Santana, DS, Silveira C, Costa ML, Souza RT, Surita FG, Souza JP, Mazhar SB, Jayaratne K, QURESHI ZAHIDA, Sousa MH, Vogel JP, Cecatti JG.  2018.  Perinatal outcomes in twin pregnancies complicated by maternal morbidity:evidence from the WHO Multicountry Survey on Maternal and Newborn Health. BMC Pregnancy and Childbirth . 18(449) AbstractWebsite

Background: Twin pregnancy was associated with significantly higher rates of adverse neonatal and perinatal outcomes, especially for the second twin. In addition, the maternal complications (potentially life-threatening conditions-PLTC, maternal near miss-MNM, and maternal mortality-MM) are directly related to twin pregnancy and independently associated with adverse perinatal outcome. The objective of the preset study is to evaluate perinatal outcomes associated with twin pregnancies, stratified by severe maternal morbidity and order of birth.

Methods: Secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health (WHOMCS), a cross-sectional study implemented in 29 countries. Data from 8568 twin deliveries were compared with 308,127 singleton deliveries. The occurrence of adverse perinatal outcomes and maternal complications were assessed. Factors independently associated with adverse perinatal outcomes were reported with adjusted PR (Prevalence Ratio) and 95%CI.

Results: The occurrence of severe maternal morbidity and maternal death was significantly higher among twin compared to singleton pregnancies in all regions. Twin deliveries were associated with higher rates of preterm delivery (37.1%), Apgar scores less than 7 at 5th minute (7.8 and 10.1% respectively for first and second twins), low birth weight (53.2% for the first and 61.1% for the second twin), stillbirth (3.6% for the first and 5.7% for the second twin), early neonatal death (3.5% for the first and 5.2% for the second twin), admission to NICU (23.6% for the first and 29.3% for the second twin) and any adverse perinatal outcomes (67% for the first twin and 72.3% for the second). Outcomes were consistently worse for the second twin across all outcomes. Poisson multiple regression analysis identified several factors independently associated with an adverse perinatal outcome, including both maternal complications and twin pregnancy.

Conclusion: Twin pregnancy is significantly associated with severe maternal morbidity and with worse perinatal outcomes, especially for the second twin.

Keywords: Maternal morbidity; Perinatal outcome; Twin pregnancy.

PUlei, AN, Shatry NA, Sura MK, Njoroge MW, Kibii DK, Mwaniki DK, Teko HP, Maranga O, Ogutu O, Vogel JP, Qureshi Z.  2018.  Updating of a clinical protocol for the prevention and management of postpartum haemorrhage at Kenyatta National Hospital, Nairobi, Kenya. East African Medical Journal. 95(2) AbstractWebsite

Background: Postpartum haemorrhage (PPH) affects 6% of births and accounts for almost 30% of maternal deaths. The use of clinical protocols for preventing and treating PPH is recommended by WHO. Protocols should be evidence-based, regularly updated, widely available and routinely adhered to.
Broad Objective: To update the Kenyatta National Hospital (KNH) PPH prevention and management protocol based on latest recommendations, and ensure its dissemination and use by providers.
Materials and Methods: A literature search identified selected PPH-related guidelines which were assessed using the AGREE-II tool for guideline quality. A matrix was created to compare recommendations across guidelines. Recommendations included in the KNH protocol were based on agreement across guidelines, guideline quality, publication year, and contextual factors in our setting. To aid implementation, an updated KNH protocol document, a clinical algorithm and a PPH management checklist were developed. These were reviewed and accepted as best practice by KNH and University of Nairobi.
Results: Six PPH-related guidelines were used (WHO, FIGO, RCOG, ACOG, FOGSI, and the Kenya National Guidelines for Quality Obstetrics and Perinatal care). The KNH protocol covers PPH prevention, including: active management of third stage, oxytocin after vaginal or caesarean delivery, other drugs for prevention (when oxytocin is not available), controlled cord traction and delayed cord clamping. It also covers PPH management (supportive and definitive measures).
Conclusion: An updated PPH prevention and management protocol for KNH was developed. Implementation and adherence will help standardize PPH-related care and improve health outcomes for women.

Widmer, M, Piaggio G, Nguyen TM, Osoti A, Owa OO, Misra S, Coomarasamy A, Abdel-Aleem H, Mallapur AA, Qureshi Z, Lumbiganon P.  2018.  Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. New England Journal of Medicine. 379(8):743-752. AbstractWebsite

Background: Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin.

Methods: We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 μg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively.

Results: A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups.

Conclusions: Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).

Muhula, S, Opanga Y, Kuyo M, Qureshi Z, Memiah P, M N.  2018.  Use of performance dashboards in health care project management: a case of an international health development organization in Kenya. Africa Health Agenda International Journal. 1(3) AbstractWebsite

In this paper we document the use of dashboards in health care project management in an international health non-governmental organization. All projects at the organization monitor output performance on specific indicators against set targets and report these as project outputs performance report every month. In addition, projects prepare quality improvement report, compliance report and financial report. The four reports are then used to generate the monthly integrated performance monitoring and management dashboard which is shared with all staff and used by project managers and programme directors to review projects performance in the 4 parameters of measure and then used to provide appropriate technical support. We conducted a client satisfaction survey among staff to assess their levels of satisfaction with the dashboard and it came out that staff consider the dashboard as a “must have” monthly project management tool as it results in timely measurement of projects’ financial performance, programmatic performance, quality of service performance and compliance performance at a glance without the need to go through detailed reports. Programme directors and project managers use the dashboard to quickly identify hotspots, detect outliers in indicators of measure in a project and use this to deeply analyse possible causes of poor performance in projects for targeted technical assistance.

2017

M, B, N PV, J RM, A C, D L, JP S, A.M G.  2017.  Towards a consensus definition of maternal sepsis: results of a systematic review and expert consultation . Reproductive Health . 14(67) AbstractWebsite

Background
There is a need for a clear and actionable definition of maternal sepsis, in order to better assess the burden of this condition, trigger timely and effective treatment and allow comparisons across facilities and countries. The objective of this study was to review maternal sepsis definitions and identification criteria and to report on the results of an expert consultation to develop a new international definition of maternal sepsis.

Methods
All original and review articles and WHO documents, as well as clinical guidelines providing definitions and/or identification criteria of maternal sepsis were included. A multidisciplinary international panel of experts was surveyed through an online consultation in March-April 2016 on their opinion on the existing sepsis definitions, including new definition of sepsis proposed for the adult population (2016 Third International Consensus Definitions for Sepsis and Septic Shock) and importance of different criteria for identification of maternal sepsis. The definition was agreed using an iterative process in an expert face-to-face consensus development meeting convened by WHO and Jhpiego.

Results
Standardizing the definition of maternal sepsis and aligning it with the current understanding of sepsis in the adult population was considered a mandatory step to improve the assessment of the burden of maternal sepsis by the expert panel. The literature review and expert consultation resulted in a new WHO consensus definition “Maternal sepsis is a life-threatening condition defined as organ dysfunction resulting from infection during pregnancy, child-birth, post-abortion, or post-partum period”. Plans are in progress to validate the new WHO definition of maternal sepsis in a large international population.

Conclusion
The operationalization of the new maternal sepsis definition requires generation of a set of practical criteria to identify women with sepsis. These criteria should enable clinicians to focus on the timely initiation of actionable elements of care (administration of antimicrobials and fluids, support of vital organ functions, and referral) and improve maternal outcomes.

Vogel, JP, Oladapo OT, Pileggi-Castro C, Adejuyigbe EA, Althabe F, Ariff S, Ayede AI, Baqui AH, Costello A, Chikamata DM, Crowther C, Fawole B, Gibbons L, Jobe AH, Kapasa ML, Kinuthia J, Kriplani A, Kuti O, Neilson J, Patterson J, Piaggio G, Qureshi R, Qureshi Z, Sankar MJ, Stringer JSA, Temmerman M, Yunis K, Bahl R, Gülmezoglu AM.  2017.  Antenatal corticosteroids for women at risk of imminent preterm birth in low-resource countries: the case for equipoise and the need for efficacy trials. British Medical Journal Global Health. 2(3) AbstractWebsite

The scientific basis for antenatal corticosteroids (ACS) for women at risk of preterm birth has rapidly changed in recent years. Two landmark trials-the Antenatal Corticosteroid Trial and the Antenatal Late Preterm Steroids Trial-have challenged the long-held assumptions on the comparative health benefits and harms regarding the use of ACS for preterm birth across all levels of care and contexts, including resource-limited settings. Researchers, clinicians, programme managers, policymakers and donors working in low-income and middle-income countries now face challenging questions of whether, where and how ACS can be used to optimise outcomes for both women and preterm newborns. In this article, we briefly present an appraisal of the current evidence around ACS, how these findings informed WHO's current recommendations on ACS use, and the knowledge gaps that have emerged in the light of new trial evidence. Critical considerations in the generalisability of the available evidence demonstrate that a true state of clinical equipoise exists for this treatment option in low-resource settings. An expert group convened by WHO concluded that there is a clear need for more efficacy trials of ACS in these settings to inform clinical practice.

Keywords: antenatal corticosteroids; neonatal mortality; preterm birth.

Motomura, K, Ganchimeg T, Nagata C, Ota E, Vogel JP, Betran AP, Torloni MR, Jayaratne K, Jwa SC, Mittal S, Recidoro ZD, Matsumoto K, Fujieda M, Nafiou I, Yunis K, QURESHI ZAHIDA, Souza JP, Mori R.  2017.  Incidence and outcomes of uterine rupture among women with prior caesarean section: WHO Multicountry Survey on Maternal and Newborn Health. Scientific Reports. 7 AbstractWebsite

Caesarean section (CS) is increasing globally, and women with prior CS are at higher risk of uterine rupture in subsequent pregnancies. However, little is known about the incidence, risk factors, and outcomes of uterine rupture in women with prior CS, especially in developing countries. To investigate this, we conducted a secondary analysis of the World Health Organization Multicountry Survey on Maternal and Newborn Health, which included data on delivery from 359 facilities in 29 countries. The incidence of uterine rupture among women with at least one prior CS was 0.5% (170/37,366), ranging from 0.2% in high-Human Development Index (HDI) countries to 1.0% in low-HDI countries. Factors significantly associated with uterine rupture included giving birth in medium- or low-HDI countries (adjusted odds ratio [AOR] 2.0 and 3.88, respectively), lower maternal educational level (≤6 years) (AOR 1.71), spontaneous onset of labour (AOR 1.62), and gestational age at birth <37 weeks (AOR 3.52). Women with uterine rupture had significantly higher risk of maternal death (AOR 4.45) and perinatal death (AOR 33.34). Women with prior CS, especially in resource-limited settings, are facing higher risk of uterine rupture and subsequent adverse outcomes. Further studies are needed for prevention/management strategies in these settings.

Use of caesarean section (CS) deliveries has been steadily increasing, from 6.7% in 1990 to 19.1% in 2014 globally1,2. Consequently, the number of deliveries by mothers with prior CS is also on the rise1.

Women with prior CS are at higher risk of uterine rupture. The reported incidence of uterine rupture among women with prior CS ranged from 0.22% to 0.5% in some developed countries3,4,5,6. The risk factors for uterine rupture in women with a history of CS include prior classical incision, labour induction or argumentation, macrosomia, increasing maternal age, post-term delivery, short maternal stature, no prior vaginal delivery, and prior periviable CS4,7,8,9,10,11. Uterine rupture poses considerable risk of adverse maternal and perinatal outcomes. The prevalence of maternal and perinatal complications, such as severe post-hemorrhagic anemia, major puerperal infection, bladder injury, hysterectomy, and perinatal mortality, are significantly higher in women with uterine rupture than women without uterine rupture4,10,12,13.

A World Health Organization (WHO) systematic review to determine the prevalence of uterine rupture worldwide identified uterine rupture as a serious obstetric complication being more prevalent and with more serious consequences in developing countries than in developed countries14. In developing countries, uterine rupture has been reportedly associated with obstructed labour, grand multiparity, injudicious obstetric interventions/manipulations, lack of antenatal care, unbooked status, poor access to emergency obstetric care, and low socioeconomic status rather than prior CS15,16,17,18. However, uterine rupture after prior CS is becoming more common as the availability of CS increases in these settings18. According to a literature review on uterine rupture in developing countries, the proportion of women with prior CS or uterine scar among women who had uterine rupture was up to 64%18. A study in India reported that the incidence of uterine rupture among women with prior CS was 1.69%19. Nevertheless, there are few studies about the incidence, risk factors, and outcomes of uterine rupture among women with prior CS from these settings.

Typically, uterine rupture occurs suddenly and requires immediate critical emergency care for mothers, fetuses, or neonates. The strategies for prevention and management, as well as the quality of affordable care for women at risk of or experiencing uterine rupture, are likely to vary across settings depending on their diagnostic capacity, availability of obstetric interventions, and human and facility resources. Therefore, the findings in developed countries may not be generalizable to low-resource countries and settings. The aim of this analysis was to describe the incidence, risk factors, and maternal and perinatal outcomes of uterine rupture among women with prior CS using data from the WHO Multicountry Survey on Maternal and Newborn Health (WHOMCS), which was conducted in facilities in 29 countries worldwide from 2010 to 2011.

Shakur, H, Roberts I, Fawole B, Chaudhri R, El-Sheikh M, desina Akintan, QURESHI ZAHIDA, Kidanto H, Vwalika B, Abdulkadir A, Etuk S, Noor S, Asonganyi E, Alfirevic Z, Beaumont D, Ronsmans C, Arulkumaran S.  2017.  Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. AbstractWebsite

Summary
Background
Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of
tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration
of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage.
Methods
In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a
clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries.
We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual
care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of
tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box
containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those
assessing outcomes were masked to allocation. We originally planned to enrol 15
000 women with a composite primary
endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became
apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although
tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore
increased the sample size from 15
000 to 20
000 women in order to estimate the effect of tranexamic acid on the risk of
death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with
ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283.
Findings
Between March, 2010, and April, 2016, 20
060
women were enrolled and randomly assigned to receive
tranexamic acid (n=10
051) or placebo (n=10
009), of whom 10
036 and 9985, respectively, were included in the analysis.
Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10
036 patients
vs
191
[1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given
treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group
vs
127 [1·7%] in the placebo group,
RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy
was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group
vs
351 [3·5%] in the placebo
group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy
was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group
vs
546 [5·5%]
in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did
not differ significantly in the tranexamic acid versus placebo group.
Interpretation
Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no
adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as
possible after bleeding onset.
Funding
London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and
Bill & Melinda Gates Foundation.

2016

J, H, Z Q.  2016.  Preventing deaths due to haemorrhage. . Best Practice & Research Clinical Obstetrics & Gynaecology Elsevier. 36:68-32.Website
Z, Q, A M.  2016.  Development of Basic Obstetric Theater Facility in a Low-resource Setting.. Gynecologic and Obstetric Surgery Challenges and Management Options.
M, W, H A-A, G C, YS C, A C, B F, S G, GJ H, P L, K M, TM N, Z Q, JP S, AM G.  2016.  Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally. Study protocol for a randomized controlled trial. 17(1) Abstract

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind noninferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth.
METHODS/DESIGN:
Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intramuscular) in the prevention of PPH and severe PPH after vaginal birth. The primary endpoints are blood loss ≥500 mL or the use of additional uterotonics (composite endpoint required by drug regulatory authorities) and blood loss ≥1,000 mL (WHO requirement). Non-inferiority will be assessed using a two-sided 95 % confidence interval for the relative risk of the above endpoints for room temperature stable carbetocin versus oxytocin. The upper limit of the two-sided 95 % confidence interval for the relative risk for the composite endpoint of blood loss ≥500 mL or the use of additional uterotonics, and for the endpoint of blood loss ≥1,000 mL, will be compared to a non-inferiority margin of 1.16 and 1.23, respectively. If the upper limit is below the corresponding mar in, non-inferiority will have been demonstrated. The safety analysis will include all wom n receiving treatment. Safety and tolerability will be assessed by a review of adverse events, by conducting inferential testing with significance levels for between-group comparisons.
DISCUSSION:
If the results of the study show that room temperature stable carbetocin is a safe and effective alternative to oxytocin, this could have a substantial impact on the prevention of postpartum haemorrhage and maternal survival worldwide.
TRIAL REGISTRATION:
ACTRN12614000870651 (14 August 2014).

Santana, DS, Cecatti JG, Surita FG, Silveira C, Costa ML, Souza JP, Mazhar SB, Jayaratne K, QURESHI ZAHIDA, Sousa MH, Vogel JP.  2016.  Pregnancy and Severe Maternal Outcomes: The World Health Organization Multicountry Survey on Maternal and Newborn Health.. Obstetrics & Gynecology. 127(4):631-641. Abstractpregnancy_and_severe_maternal_outcomes.pdf

OBJECTIVE: To evaluate maternal complications (potentially life-threatening conditions, maternal near miss, and maternal death) that are mutually exclusive and severe maternal outcomes (maternal near miss or maternal death) associated with twin pregnancies.
METHODS: We performed a secondary analysis of a cross-sectional World Health Organization Multicountry Survey, which was implemented in 29 countries. Data from 4,756 twin deliveries were compared with 308,111 singleton deliveries. Factors associated with maternal morbidity and twin pregnancies were reported with adjusted prevalence ratio (95% confidence interval).
RESULTS: Potentially life-threatening conditions, maternal near miss, severe maternal outcomes, and maternal deaths were 2.14 (1.99–2.30), 3.03 (2.39–3.85), 3.19 (2.58–3.94), and 3.97 (2.47–6.38) times higher, respectively, among twin pregnancies. Maternal age older than 20 years, having a partner, multiparity, and elective cesarean delivery were associated with twin pregnancies. Postpartum hemorrhage and chronic hypertension were more frequently associated with severe maternal outcomes among twin pregnancies. Conditions indicating organ dysfunction (maternal near miss) were twofold to fivefold higher for twins. Poisson multiple regression analysis identified several factors independently associated with a severe maternal outcome, but not twin pregnancies.
CONCLUSION: Twin pregnancy is associated with greater severe maternal morbidity and a higher rate of maternal death than singleton pregnancy.

2015

Vogel, JP, Betrán AP, Vindevoghel N, Souza JP, M. R. Torloni ZJ, Tuncalp O, Mori R, Morisaki N, Ortiz-Panozo E, Hernandez B, Pérez-Cuevas R, Qureshi Z, Gülmezoglu AM, Temmerman M.  2015.  Use of the Robson classification to assess caesarean section trends in 21 countries. A secondary analysis of two WHO multicountry surveys Lancet Glob Health, 2015.. Abstract

Background
Rates of caesarean section surgery are rising worldwide, but the determinants of this increase, especially in low-income and middle-income countries, are controversial. In this study, we aimed to analyse the contribution of specific obstetric populations to changes in caesarean section rates, by using the Robson classification in two WHO multicountry surveys of deliveries in health-care facilities. The Robson system classifies all deliveries into one of ten groups on the basis of five parameters: obstetric history, onset of labour, fetal lie, number of neonates, and gestational age.
Methods
We studied deliveries in 287 facilities in 21 countries that were included in both the WHO Global Survey of Maternal and Perinatal Health (WHOGS; 2004–08) and the WHO Multi-Country Survey of Maternal and Newborn Health (WHOMCS; 2010–11). We used the data from these surveys to establish the average annual percentage change (AAPC) in caesarean section rates per country. Countries were stratified according to Human Development Index (HDI) group (very high/high, medium, or low) and the Robson criteria were applied to both datasets. We report the relative size of each Robson group, the caesarean section rate in each Robson group, and the absolute and relative contributions made by each to the overall caesarean section rate.
Findings
The caesarean section rate increased overall between the two surveys (from 26·4% in the WHOGS to 31·2% in the WHOMCS, p=0·003) and in all countries except Japan. Use of obstetric interventions (induction, prelabour caesarean section, and overall caesarean section) increased over time. Caesarean section rates increased across most Robson groups in all HDI categories. Use of induction and prelabour caesarean section increased in very high/high and low HDI countries, and the caesarean section rate after induction in multiparous women increased significantly across all HDI groups. The proportion of women who had previously had a caesarean section increased in moderate and low HDI countries, as did the caesarean section rate in these women.
Interpretation
Use of the Robson criteria allows standardised comparisons of data across countries and timepoints and identifies the subpopulations driving changes in caesarean section rates. Women who have previously had a caesarean section are an increasingly important determinant of overall caesarean section rates in countries with a moderate or low HDI. Strategies to reduce the frequency of the procedure should include avoidance of medically unnecessary primary caesarean section. Improved case selection for induction and prelabour caesarean section could also reduce caesarean section rates.
Funding
None.

Osoti, A, Gwako GN, Liyayi B, Qureshi ZP.  2015.  Distinguishing Intrauterine Fetal Demise versus Abdominal Pregnancy in Low Resource Settings. East African Medical Journal. 92(1) Abstractdistinguishing_intrauterine_fetal_demise_versus_abdominal_pregnancy_in_low_resource_settings.pdf

Diagnosis of abdominal pregnancy always poses a clinical dilemma. Transvaginal ultrasound is the ideal radiological procedure in locating these pregnancies. However in resource limited setting, abdominal and pelvic ultrasounds can be the only available yet unreliable modalities for distinguishing intrauterine versus abdominal pregnancies. We present a case of a 36 year old para 4+0 gravida 5 who presented with fetal demise at 16 weeks of gestation. Multiple abdominal and pelvic ultrasounds showed intra uterine fetal demise for which she underwent induction. The definitive diagnosis of abdominal pregnancy was established using transcervical Foleys catheter aided abdominal-pelvic ultrasound which showed an empty uterus and a gestational sac, placenta and a 16-week fetus with no cardiac activity in the right adnexa/iliac region.

Okusanya, BO, Oladapo OT, Long Q, Lumbiganon P, Carroli G, Qureshi Z, Duley L, Souza JP, Gulmezoglu AM.  2015.  Clinical pharmacokinetic properties of magnesium sulphate in women with preeclampsia and eclampsia. A systematic Review 2015. Abstractclinical_pharmacokinetic_properties_of_magnesium_sulphate_in_women_with_pre.pdf

Background
The pharmacokinetic basis of magnesium sulphate (MgSO4) dosing regimens for eclampsia prophylaxis and treatment is not clearly established.
Objectives
To review available data on clinical pharmacokinetic properties of MgSO4 when used for women with pre-eclampsia and/or eclampsia.
Search strategy
MEDLINE, EMBASE, CINAHL, POPLINE, Global Health Library and reference lists of eligible studies.
Selection criteria
All study types investigating pharmacokinetic properties of MgSO4 in women with preeclampsia and/or eclampsia.
Data collection and analysis
Two authors extracted data on basic pharmacokinetic parameters reflecting the different aspects of absorption, bioavailability, distribution and excretion of MgSO4 according to identified dosing regimens.
Main results
Twenty-eight studies investigating pharmacokinetic properties of 17 MgSO4 regimens met our inclusion criteria. Most women (91.5%) in the studies had pre-eclampsia. Baseline serum magnesium concentrations were consistently <1 mmol/l across studies. Intravenous loading dose between 4 and 6 g was associated with a doubling of this baseline concentration half an hour after injection. Maintenance infusion of 1 g/hour consistently produced concentrations well below 2 mmol/l, whereas maintenance infusion at 2 g/hour and the Pritchard intramuscular regimen had higher but inconsistent probability of producing concentrations between 2 and 3 mmol/l. Volume of distribution of magnesium varied (13.65–49.00 l) but the plasma clearance was fairly similar (4.28–5.00 l/hour) across populations.
Conclusion
The profiles of Zuspan and Pritchard regimens indicate that the minimum effective serum magnesium concentration for eclampsia prophylaxis is lower than the generally accepted level. Exposure–response studies to identify effective alternative dosing regimens should target concentrations achievable by these standard regimens.

2014

Souza, JP, Widmer M, Gülmezoglu AM, Lawrie TA, Adejuyigbe EA, Carroli G, Crowther C, Currie SM, Dowswell T, Hofmeyr J, Lavender T, Lawn J, Mader S, Martinez FE, Mugerwa K, QURESHI ZAHIDA, Silvestre MA, Soltani H, Torloni MR, Tsigas EZ, Vowles Z, Ouedraogo L, Serruya S, Al-Raiby J, Awin N, Obara H, Mathai M, Bahl R, Martines J, Ganatra B, Phillips SJ, Johnson BR, Vogel JP, Oladapo OT, Temmerman M.  2014.  Maternal and perinatal health research priorities beyond 2015: an international survey and prioritization exercise., 2014. Reproductive health. 11:61. Abstract

Maternal mortality has declined by nearly half since 1990, but over a quarter million women still die every year of causes related to pregnancy and childbirth. Maternal-health related targets are falling short of the 2015 Millennium Development Goals and a post-2015 Development Agenda is emerging. In connection with this, setting global research priorities for the next decade is now required.

Vogel, JP, Souza JP, Gülmezoglu MA, Mori R, Lumbiganon P, QURESHI ZAHIDA, Carroli G, Laopaiboon M, Fawole B, Ganchimeg T, Zhang J, Torloni MR, Bohren M, Temmerman M.  2014.  Use of antenatal corticosteroids and tocolytic drugs in preterm births in 29 countries: an analysis of the WHO Multicountry Survey on Maternal and Newborn Health., 2014 Nov 22. Lancet. 384(9957):1869-77. Abstract

Despite the global burden of morbidity and mortality associated with preterm birth, little evidence is available for use of antenatal corticosteroids and tocolytic drugs in preterm births in low-income and middle-income countries. We analysed data from the WHO Multicountry Survey on Maternal and Newborn Health (WHOMCS) to assess coverage for these interventions in preterm deliveries.

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