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Objective: In the context of rapid changes regarding practices related to delivery in Africa, we assessed maternal and perinatal adverse outcomes associated with the mode of delivery in 41 referral hospitals of Mali and Senegal. Study Design: Cross-sectional survey nested in a randomised cluster trial (1/10/2007-1/10/2008). The associations between intended mode of delivery and (i) in-hospital maternal mortality, (ii) maternal morbidity (transfusion or hysterectomy), (iii) stillbirth or neonatal death before Day 1 and (iv) neonatal death between 24 hours after birth and hospital discharge were examined. We excluded women with immediate life threatening maternal or fetal complication to avoid indication bias. The analyses were performed using hierarchical logistic mixed models with random intercept and were adjusted for women’s, newborn’s and hospitals’ characteristics. Results: Among the 78,166 included women, 2.2% had a pre-labor cesarean section (CS) and 97.8% had a trial of labor. Among women with a trial of labor, 87.5% delivered vaginally and 12.5% had intrapartum CS. Pre-labor CS was associated with a marked reduction in the risk of stillbirth or neonatal death before Day 1 as compared with trial of labor (OR = 0.2 [0.16-0.36]), though we did not show that maternal mortality (OR = 0.3 [0.07-1.32]) and neonatal mortality after Day 1 (OR = 1.3 (0.66-2.72]) differed significantly between groups. Among women with trial of labor, intrapartum CS and operative vaginal delivery were associated with higher risks of maternal mortality and morbidity, and neonatal mortality after Day 1, as compared with spontaneous vaginal delivery. Conclusions: In referral hospitals of Mali and Senegal, pre-labor CS is a safe procedure although intrapartum CS and operative vaginal delivery are associated with increased risks in mothers and infants. Further research is needed to determine what aspects of obstetric care contribute to a delay in the provision of intrapartum interventions so that practices may be made safer when they are needed. © 2012 Briand et al.
We conducted a cross-sectional epidemiological survey nested in a cluster-randomised trial (QUARITE trial) in Senegal and Mali (the QUARITE trial is registered on the Current Controlled Trials website under the number ISRCTN46950658 http://www.controlled-trials.com/). The trial was approved by the ethics committee of Sainte-Justine Hospital in Montreal, Canada, the “Comité National d’Ethique pour la Santé et les Sciences de la vie (CNESS)” of the Ministry of Health in Mali, and the “Conseil National de la Recherche en Santé (CNRS)” of the Ministry of Health in Senegal. Individual informed consent was not sought as clinical data were collected at the institutional level from medical records and hospital registers without identifying the individual women. Informed consent at the institutional level was obtained from the responsible authority (director of the centre and chief of maternity services) of the participating health facilities. The study protocol of the QUARITE trial has already been published [9]. Briefly, the trial aimed to assess the effectiveness of quality care improvement program (the Advances in Labor and Risk Management (ALARM) International Program) to reduce maternal mortality. The trial was conducted in 46 referral hospitals spread across both countries from October 2007 to September 2011. For the present study we used the data collected during the first year of the trial (from October 2007 to October 2008) while hospitals had not been randomised yet neither the ALARM International program implemented. This pre-intervention phase of the trial (October 2007-October 2008) aimed to provide baseline data to verify the comparability of the groups (ALARM program vs. control) in terms of the characteristics of the centres and of the women included. Five out of the 46 participating hospitals were excluded from our analysis because four did not carry out any CS during the study period (October 2007-October 2008) and one only had data from mid-2008. Among the 41 included hospitals (20 in Mali and 21 in Senegal), 12 were located in the capital, 14 were regional hospitals outside the capital and 15 were district hospitals. Data was collected from medical records by trained midwives who were supervised by the national coordinators of the survey. In each country, data was collected on a daily basis on every woman who gave birth in every selected facility. The database for this study included information on maternal demographic characteristics, obstetric history (gravidity, parity and previous CS), prenatal care (number of antenatal care visits during the current pregnancy), management of labor and delivery, obstetric complications, and the vital status of both mother and child until hospital discharge. Medical conditions and obstetric complications were reported by midwives using open questions and a pre-defined list of diagnoses, except for pre-eclampsia/eclampsia, prolonged/obstructed labor, rupture of the uterus, haemorrhage and genital infection that must be reported systematically. To avoid under-reporting of in-hospital maternal mortality, a complementary procedure was carried out to identify the eligible maternal deaths among all the female deaths that occurred in the facility using the various registries available (admissions, hospitalizations, operating theatres and morgues). For each institution, available equipment and human resources for obstetric care were recorded using a standardised inventory developed by Villar et al. for the WHO global survey on maternal and perinatal health [10]. Because resources may change over time, we collected the information at the beginning and at the end of the study period. Women who delivered during the first half time period of the study were assumed to have access to resources recorded by the first inventory. The second half time period corresponded to the second inventory. The scarcest resources were those related to the child (fetal monitoring, neonatal care, alpha fetoprotein and fetal pH scalp available in, respectively, 24.4%, 23.2%, 4.9% and 2.4% of hospitals). Other resources were available in 40.0% to 100.0% of hospitals such as blood bank (84.1%), safe blood (52.4%) and adult intensive care unit (41.5%). In all hospitals located in the capital there were obstetrics specialists and anaesthetists 24 h/day, in all regional hospitals there were obstetrics specialists, and anaesthetists 24 h/day were present in half of them. In contrast, in district hospitals, three-quarter had trained general practitioners only and anaesthetists on call. All women with single pregnancy, living in Senegal or Mali, who delivered in the selected health facilities a newborn weighting more than 500 grams were eligible for analyses. To limit confounding by indication, referring to the fact that antenatal maternal morbidity may be both the indication for CS and the cause of maternal or perinatal death, we excluded women with immediate life threatening maternal or fetal complication (placenta praevia, severe pre-eclampsia, prerupture or rupture of the uterus, transverse lie, brow presentation, or major cephalopelvic disproportion [11]) (Figure S1). Most (98%) of these women had a cesarean section. The two maternal outcomes were: (i) in-hospital maternal mortality defined as the death of the woman before hospital discharge and (ii) severe maternal morbidity, corresponding to blood transfusion or hysterectomy (the variable was coded 1 if transfusion and/or hysterectomy were reported and 0 otherwise). The two child outcomes consisted in (i) stillbirth or immediate neonatal mortality within 24 hours after birth (hereinafter referred to as “fetal/immediate neonatal mortality”), as we could not distinguish between ante- and intrapartum stillbirths and misclassifications may have occurred between fetal and neonatal death, and (ii) early neonatal mortality, which consisted in deaths that occurred more than 24 hours after birth and up to hospital discharge (hereinafter referred to as “neonatal mortality after Day 1”). The primary predictor variable of interest was the mode of delivery. It was defined at four levels: spontaneous vaginal delivery, operative vaginal delivery (vacuum or forceps), emergency intrapartum CS (corresponding to CS indicated during either spontaneous or induced labor), and pre-labor CS (corresponding to CS scheduled before the onset of labor). First, we based the analyses on the concept of “intention-to-treat” in comparing all women with intended pre-labor CS with all women who had a trial of labor, which could result in spontaneous or operative vaginal delivery or intrapartum CS. Then, among women with a trial of labor, we compared those with intrapartum CS with those who delivered vaginally: spontaneous and operative delivery (forceps and/or vacuum). Finally, we compared pre-labor CS with spontaneaous vaginal delivery. For each outcome variable of interest, the analysis was performed using a two-step procedure. As the first step, we examined potential confounders of the association between specific maternal or child outcome and mode of delivery at individual level (woman or newborn characteristics). These variables were selected based on previous studies in low- or middle-income countries [1], [12]: age (2 classes: <35 years, ≥35 years), parity (2 classes: nulliparous, parous), number of antenatal care visits (2 classes: 0, ≥1), previous CS, medical conditions diagnosed before index pregnancy (2 classes: none versus at least one of the following conditions reported: HIV, chronic respiratory conditions, cardiac or renal diseases, sickle cell trait and chronic hypertension), referral from another health facility – which was considered as a potential marker for more severe conditions because of delays due to large travel distances or lack of transportation –, pregnancy-induced hypertension or mild pre-eclampsia, vaginal bleeding near full term, premature rupture of the membranes, chorioamniotis and other medical/obstetric conditions diagnosed during current pregnancy but before the onset of labor (2 classes: none versus at least one of the following conditions reported: pyelonephritis or urinary infection, chorioamniotis, severe maternal anaemia, malaria, gestational diabetes, suspected intrauterine death and suspected intrauterine growth retardation). We considered that women did not have a condition if it had not been reported by a midwife. Birth weight was always included in the models that were fitted to child outcomes (the variable was categorised in 6 classes: <2,000 grams, [2,000–2,500], [2,500–3,000], [3,000–3,500], [3,500–4,000], ≥4,000). First, tri-variate analyses (i.e., adjusted for country and time period) were performed to assess crude associations between mode of delivery and all the aforementioned individual-level variables. Then, a multivariable analysis was conducted. All variables were included in the final model, regardless of their associations with outcomes in tri-variate analyses. As the second step of these analyses, we examined potential confounders, at institutional-level (hospital characteristics), of the associations between the mode of delivery and specific maternal or child outcome, while adjusting for individual factors that were selected into the multivariable model estimated at the first step. Institutional factors considered for these analyses were selected a priori based on essential resources for emergency obstetric care defined by Villar et al. for the WHO [10]. The final multivariable model included only those institutional variables that were selected by a forward-stepwise procedure (with a P<0.01 criterion for entry). We used a forward elimination procedure to account for very high sample size and high correlation between institutional variables. The time period and the country were forced into the final multivariable model. Two sensitivity analyses were conducted. First, to control for indication bias, we assessed the relationship between the mode of delivery and maternal outcomes, while restricting the analysis to “low-risk” women, i.e. women aged <35 years, who had no medical conditions before or during the current pregnancy, no previous CS and who gave birth to a child weighting more than 2,500 grams (this criterion was used as a proxy for a term birth as we did not collect gestational age at delivery). Second, only early maternal deaths (within 24 hours after delivery) were included to take into account the fact that women with vaginal delivery tend to be discharged earlier compared to those with CS. To take into account the hierarchical structure of the data, we used a hierarchical logistic mixed model with random intercept to model dependence of outcomes for individual women who delivered in the same hospital [13]. The effects of both individual and institutional factors on maternal and child outcomes were assumed to be the same for all hospitals and, accordingly, were modelled as fixed effects. We calculated numbers needed to treat to benefit (NNTB) or to harm (NNTH) for maternal and child outcomes from the adjusted OR and its confidence interval [14]. All statistical analyses were performed using the SAS system software (SAS Institute Inc., Cary, NC, USA). Hierarchical logistic mixed models were estimated using the PROC NLMIXED procedure.
