A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt.

BACKGROUND: Previous community-based research shows that secondary prevention of postpartum hemorrhage (PPH) with misoprostol only given to women with above-average measured blood loss produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH. Given the difficulty of routinely measuring blood loss for all deliveries, more operational models of secondary prevention are needed. METHODS: This cluster-randomized, non-inferiority trial included women giving birth with nurse-midwives at home or in Primary Health Units (PHUs) in rural Egypt. Two PPH management approaches were compared: 1) 600mcg oral misoprostol given to all women after delivery (i.e. primary prevention, current standard of care); 2) 800mcg sublingual misoprostol given only to women with 350-500 ml postpartum blood loss estimated using an underpad (i.e. secondary prevention). The primary outcome was mean change in pre- and post-delivery hemoglobin. Secondary outcomes included hemoglobin ≥2 g/dL and other PPH interventions. RESULTS: Misoprostol was administered after delivery to 100% (1555/1555) and 10.7% (117/1099) of women in primary and secondary prevention clusters, respectively. The mean drop in pre- to post-delivery hemoglobin was 0.37 (SD: 0.91) and 0.45 (SD: 0.76) among women in primary and secondary prevention clusters, respectively (difference adjusted for clustering = 0.01, one-sided 95% CI: < 0.27, p = 0.535). There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions. CONCLUSIONS: Misoprostol for secondary prevention of PPH is comparable to universal prophylaxis and can be implemented using local materials, such as underpads. TRIAL REGISTRATION: Clinicaltrials.gov NCT02226588, date of registration 27 August 2014.

Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial.

BACKGROUND: Oxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended equally and little discussion of potential differences between the two. This trial assesses the effectiveness and safety of 10 IU oxytocin administered as IM injection versus IV infusion and IV bolus during the third stage of labor for PPH prophylaxis. METHODS: In two tertiary level Egyptian maternity hospitals, women delivering vaginally without exposure to pre-delivery uterotonics were randomized to one of three prophylactic oxytocin administration groups after delivery of the baby. Blood loss was measured 1 h after delivery, and side effects were recorded. Primary outcomes were mean postpartum blood loss and proportion of women with postpartum blood loss ≥500 ml in this open-label, three-arm, parallel, randomized controlled trial. RESULTS: Four thousand nine hundred thirteen eligible, consenting women were randomized. Compared to IM injection, mean blood loss was 5.9% less in the IV infusion arm (95% CI: -8.5, - 3.3) and 11.1% less in the IV bolus arm (95% CI: -14.7, - 7.8). Risk of postpartum blood loss ≥500 ml in the IV infusion arm was significantly less compared to IM injection (0.8% vs. 1.5%, RR = 0.50, 95% CI: 0.27, 0.91). No side effects were reported in any arm. CONCLUSIONS: Intravenous oxytocin is more effective than intramuscular injection for the prevention of PPH in the third stage of labor. Oxytocin delivered by IV bolus presents no safety concerns after vaginal delivery and should be considered a safe option for PPH prophylaxis. TRIAL REGISTRATION: clinicaltrials.gov # NCT01914419 , posted August 2, 2013.

A cross sectional study of maternal 'near-miss' cases in major public hospitals in Egypt, Lebanon, Palestine and Syria.

BACKGROUND: The maternal near-miss approach has been increasingly used as a tool to evaluate and improve the quality of care in maternal health. We report findings from the formative stage of a World Health Organization (WHO) funded implementation research study that was undertaken to collect primary data at the facility level on the prevalence, characteristics, and management of maternal near-miss cases in four major public referral hospitals - one each in Egypt, Lebanon, Palestine and Syria. METHODS: We conducted a cross sectional study of maternal near-miss cases in the four contexts beginning in 2011, where we collected data on severe maternal morbidity in the four study hospitals, using the WHO form (Individual Form HRP A65661). In each hospital, a research team including trained hospital healthcare providers carried out the data collection. RESULTS: A total of 9,063 live birth deliveries were reported during the data collection period across the four settings, with a total of 77 cases of severe maternal outcomes (71 maternal near-miss cases and 6 maternal deaths). Higher indices for the maternal mortality index were found in both Al Galaa hospital, in Egypt (8.6%) and Dar Al Tawleed hospital in Syria (14.3%), being large referral hospitals, compared to Ramallah hospital in Palestine and Rafik Hariri University hospital in Lebanon. Compared to the WHO's Multicountry Survey using the same data collection tool, our study's mortality indices are higher than the index of 5.6% among countries with a moderate maternal mortality ratio in the WHO Survey. Overall, haemorrhage-related complications were the most frequent conditions among maternal near-miss cases across the four study hospitals. In all hospitals, coagulation dysfunctions (76.1%) were the most prevalent dysfunction among maternal near-miss cases, followed by cardiovascular dysfunctions. The coverage of key evidence-based interventions among women experiencing a near-miss was either universal or very high in the study hospitals. CONCLUSIONS: Findings from this formative stage confirmed the need for quality improvement interventions. The high reported coverage of the main clinical interventions in the study hospitals would appear to be in contradiction with the above findings as the level of coverage of key evidence-based interventions was high.

Hospital practice versus evidence-based obstetrics: categorizing practices for normal birth in an Egyptian teaching hospital.

BACKGROUND: Little is known of common normal labor hospital practices in Egypt or of their relationship to evidence-based obstetrics. This study documented facility-based practices for normal labor and delivery in Egypt for the first time by categorizing 44 practices observed in a busy obstetric teaching hospital according to the World Health Organization (WHO) Technical Working Group on Normal Birth classification of normal birth practices. METHODS: A multidisciplinary approach combined directly observing practices that were applied to individual laboring women and their newborns, observing ward activities, interviews, and focus groups. One hundred seventy-five normal births were observed in their entirety, over 28 days and nights, by medically trained observers using an observation checklist that documented 537 variables for each woman. Mothers were interviewed postpartum, and findings were shared with practitioners for their feedback. Observed practices were categorized according the 1999 WHO classification of 59 practices for normal birth, depending on their usefulness, effectiveness, or harmfulness. RESULTS: There was infrequent use of beneficial practices that should be encouraged and an unexpectedly high level of harmful practices that should be eliminated. Some beneficial practices were applied inappropriately, and practices of unproved benefit were also documented, some of which are potentially harmful to childbearing mothers and their babies. CONCLUSIONS: Hospital practices for normal labor were largely not in accordance with the WHO evidence-based classification of practices for normal birth. The findings are worrying, given the increasing proportion of hospital-based births in Egypt and the country's improved but relatively high maternal and neonatal mortality rates. Obstacles to following evidence-based protocols for normal labor require examination.