Postpartum Hemorrhage

The primary outcome was a composite of peri-natal death or severe neonatal complications and consisted of one or more of the following during the antepartum or intrapartum period or during the delivery hospitalization: perinatal death, the need for respiratory support within 72 hours after birth, Apgar score of 3 or less at 5 minutes, hypoxic–ischemic encephalopathy,^{17 (link)} seizure, infection (confirmed sepsis or pneumonia), meconium aspiration syndrome, birth trauma (bone fracture, neurologic injury, or retinal hemorrhage), intracranial or subgaleal hemorrhage, or hypo-tension requiring vasopressor support. The principal prespecified maternal outcome (the main secondary outcome) was cesarean delivery.
Prespecified subgroups for the primary perinatal outcome and for the secondary outcome of cesarean delivery were maternal race or ethnic group as reported by the participant (white, black, Asian, Hispanic, other, unknown, or more than one race), age of 35 years or older versus younger than 35 years, body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more versus less than 30, and a modified Bishop score at the time of randomization of less than 5 versus 5 or higher. In addition, although it was not a baseline variable, the specialty of the admitting provider (obstetrics-gynecology, maternal-fetal medicine, family practice, or midwifery) was prespecified for the subgroup analyses.
Neonatal secondary outcomes included birth weight, duration of respiratory support, cephalohematoma, shoulder dystocia, transfusion of blood products, hyperbilirubinemia requiring photo-therapy or exchange transfusion, hypoglycemia requiring intravenous therapy, admission to the neonatal intermediate or intensive care unit, and length of hospitalization. In addition to cesarean delivery, other maternal secondary outcomes included hypertensive disorders of pregnancy (gestational hypertension or preeclampsia), indication for cesarean delivery, operative vaginal delivery, indication for operative vaginal delivery, uterine incisional extensions during cesarean delivery, chorioamnionitis, third-degree or fourth-degree perineal laceration, postpartum hemorrhage, postpartum infection, venous thromboembolism, number of hours in the labor and delivery unit, length of postpartum hospital stay, admission to the intensive care unit, and maternal death. Definitions of secondary outcomes are provided in the Supplementary Appendix.
Records of all infants who met the primary perinatal outcome were reviewed centrally to verify that the primary outcome had occurred. Records of infants in whom the primary outcome did not occur but that suggested (on the basis of a delivery hospitalization of 7 or more days or discharge to a long-term care facility) that clinically significant perinatal complications may have occurred were reviewed centrally as well. Reviewers were unaware of the trial-group assignments.

A prospective cohort study was implemented in the Western Province of Rwanda between September 2010 and September 2011, with two intervention health posts and one control health post. Currently, the health post is the lowest level of the healthcare infrastructure where women can receive ambulatory level reproductive healthcare services and the health center is the lowest level where women in labor receive care (intrapartum services). At one intervention health post, ambulatory care was thus further decentralized from the health post to the village level, with a mobile nurse providing in-home comprehensive reproductive health care. This nurse worked closely with the community health workers to organize this village-level health care service. At least one or two of these community workers, who live and work in every village in Rwanda, are responsible for assisting all pregnant women in attending their prenatal care appointments and accompanying them to a health care facility at the time of labor.
At the second intervention health post, intrapartum care was further decentralized from the local health center to the level of the health post. This was accomplished by the opening of a maternity center where women in labor could deliver their babies. This center was staffed by trained nurses and referral services were established to the district hospital for high risk cases. No changes to services were made at the control site for the study.
Convenience sampling of all pregnant women living in the catchment areas of the three health posts was performed. Women receiving ANC at any of these sites were eligible for inclusion. At the control site and the decentralized intrapartum site, all women presenting for ANC were individually educated about the study and recruited to participate. A study nurse consented the women who agreed to participate in the study. At the decentralized ambulatory care site, women willing to participate received group education in the villages by the mobile nurse followed by individual written informed consent. After delivery, data were abstracted from the existing ANC charts, partographs, and intrapartum charts.
The primary outcome of interest was lack of SAB. Secondary outcome was having at least three ANC visits. SAB was defined as receiving intrapartum and postpartum care by a nurse, midwife, or physician at a health center, district hospital, or at the study health post with decentralized intrapartum care. Data on the following maternal and neonatal outcomes were also gathered: intra-partum hemorrhage, post-partum hemorrhage, obstetric fistulae, intrapartum or postpartum fever, retained placenta, eclampsia, hysterectomy, maternal death, admission to the neonatal intensive care unit, perinatal death, neonatal sepsis.
Two distance variables were defined. Village-delivery site distance was defined as the average number of minutes it takes to walk from village to delivery site. Village-ANC site distance was defined as the average number of minutes it takes to walk from village to ANC site.
Associations of socio-demographic and distance variables with the two outcomes were evaluated using Chi-square and ANOVA tests for categorical and continuous variables, respectively. Number of ANC visits was dichotomized at the median to greater than or equal to three visits. Chi-square was used to evaluate bivariate associations between the above defined outcome variables and intervention site. A Chi-square test was also done to evaluate the association between number of ANC visits and having no SAB. Adverse outcomes were dichotomized and bivariate tests were done to evaluate for associations with the outcome variables of interest and intervention site.
Backward stepwise multivariate logistic regression analysis was performed for predicting the factors associated with the two outcomes of interest. Simultaneous evaluation for confounding was done to create an appropriately adjusted model that best fit the data. Statistical analyses were done using STATA software, version 11 (College Station, TX: StataCorp, LP). Two-sided tests were used, with statistical significance defined as having p<0.05.
The Rwandan National Ethics Committee and the Institutional Review Board at Albert Einstein College of Medicine/Montefiore Medical Center approved this study.