Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.

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. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).

A Randomized Control Trial of 3 IU IV Oxytocin Bolus with 7 IU Oxytocin Infusion versus 10 IU Oxytocin Infusion During Cesarean Section for Prevention of Postpartum Hemorrhage.

PURPOSE: Oxytocin is the preferred choice for prophylaxis and treatment of postpartum hemorrhage. Intravenous infusion has been a widely accepted route for Oxytocin administration. However, intravenous bolus route is not a readily preferred route due to apprehensions regarding hypotension that it may cause. This trial compares low dose 3 IU intravenous (IV) bolus Oxytocin along with 7 IU Oxytocin in intravenous infusion to 10IU Oxytocin intravenous infusion during cesarean section. PATIENTS AND METHODS: A total of 250 term pregnant women were randomized to either 3 IU intravenous bolus with 7 IU intravenous infusion of Oxytocin or 10IU of intravenous Oxytocin infusion. The difference in pre- and post-operative hemoglobin levels, tone of the uterus, hemodynamic changes, adverse effects of the drug, need for additional uterotonics and need for blood transfusions were assessed. RESULTS: There was 6.7% less blood loss in the 3 IU IV bolus Oxytocin with 7 IU Oxytocin infusion group in comparison to the Oxytocin infusion group. The tone of the uterus was firmer in IV bolus Oxytocin with Oxytocin infusion group at 5 minutes (p<0.001) than the Oxytocin infusion group. There was no significant difference in the hemodynamic changes, adverse effects or need for blood transfusions. CONCLUSION: Intravenous bolus of 3 IU Oxytocin along with 7 IU infusion of Oxytocin is as safe and more effective than intravenous infusion of 10 IU of Oxytocin during cesarean section in the prevention of postpartum hemorrhage.