Buccal misoprostol to prevent hemorrhage at cesarean delivery: a randomized study.

OBJECTIVE: The purpose of this study was to assess the efficacy of buccal misoprostol to decrease uterine atony, hemorrhage, and the need for additional uterotonic agents during cesarean delivery. STUDY DESIGN: Patients who underwent cesarean delivery were assigned randomly to either 200-microg misoprostol or placebo placed in the buccal space. A dilute intravenous oxytocin infusion was given to all patients at delivery of the placenta. The primary outcome variable was the need for additional uterotonic agents. RESULTS: A total of 352 women received random assignments. Demographic and intrapartum characteristics were similar between the groups. More women in the placebo group required 1 additional uterotonic agent (43% vs 26%; P < .01; relative risk, 1.3; 95% CI, 1.10, 1.50). There was not a difference between the groups in the incidence of postpartum hemorrhage or a difference in preoperative and postoperative hemoglobin level. CONCLUSION: Buccal misoprostol reduces the need for additional uterotonic agents during cesarean delivery.

Buccal misoprostol to decrease blood loss after vaginal delivery: a randomized trial.

OBJECTIVE: To assess the efficacy of buccal misoprostol to decrease bleeding after vaginal delivery. METHODS: This was a randomized study of patients between 22 weeks and 42 weeks of gestation with anticipated vaginal delivery. Patients were given either a 200-mug misoprostol tablet or placebo in the buccal space at the time of cord clamping. A continuous dilute intravenous oxytocin infusion was given to all patients at delivery of the placenta. Postpartum hemorrhage was defined as blood loss exceeding 500 mL. Sample size calculations based on previous studies assumed a 13% incidence of postpartum hemorrhage in the control group. To show a statistically significant reduction of postpartum hemorrhage a total of 1,604 patients would be required in each group. RESULTS: A total of 848 patients were enrolled and 756 randomly assigned, 377 in the misoprostol group and 379 in the placebo group. Demographic, antepartum, and intrapartum characteristics were similar between the groups. The incidence of postpartum hemorrhage, 3% compared with 5%, (relative risk 0.65, 95% confidence interval 0.33-1.29, P = .22), mean estimated blood loss, 322 compared with 329 mL, (P = .45), and mean minutes of the third stage of labor, 6.7 compared with 6.9 (P = .52) were similar between the groups, misoprostol and placebo, respectively. Hemoglobin difference before and after delivery, need for second or third uterotonic agent, and all measured neonatal variables including birth weights, and umbilical cord pH were similar between the groups. CONCLUSION: Buccal misoprostol at cord clamping is no more effective than placebo in reducing postpartum hemorrhage.

Rofecoxib versus magnesium sulfate to arrest preterm labor: a randomized trial.

OBJECTIVE: To compare oral rofecoxib with intravenous magnesium sulfate as a tocolytic. METHODS: This was a randomized study of patients who were between 22 and 34 weeks of gestation with preterm labor. Patients were randomly assigned to receive either daily oral rofecoxib (50 mg) or intravenous magnesium sulfate for a maximum of 48 hours. Outcome variables included delay of delivery for 48 hours and the incidence of side effects. Data were analyzed by using the Student t test, Mann-Whitney U test, chi(2) test, and repeated-measures analysis of variance. Sample size calculations were based on previous studies of tocolytic efficacy. RESULTS: Two hundred fourteen patients were randomly assigned (105 received rofecoxib and 109 received magnesium sulfate). Delivery was delayed for 48 hours in 95 (90.4%) and 96 (88%) of the patients in the rofecoxib and magnesium sulfate groups, respectively (relative risk 0.97; 95% confidence interval 0.89, 1.06). To show a statistically significant benefit in delay of delivery past 48 hours, a total of 2,686 patients would be required in each group. There was no difference between the groups over the course of the study in cervical dilatation, amniotic fluid index, or cervical length by vaginal ultrasonography. The median hospital days on the original admission were also similar at 2 for both groups (P =.10). There was a higher reported incidence of maternal side effects in the magnesium sulfate group (relative risk 1.81; 95% confidence interval 1.07, 3.06). There was no difference in the incidence of neonatal side effects. CONCLUSION: There was no difference between oral rofecoxib and intravenous magnesium sulfate in arresting preterm labor.