The gentlebirth.org website is provided courtesy of
Ronnie Falcao, LM MS, a homebirth midwife in Mountain View, CA

Is Rectal Misoprostol Really Effective in the Treatment of Third Stage of Labor? A Randomized Controlled Trial

Caliskan E, Meydanli MM, Dilbaz B, Aykan B, Sonmezer M, Haberal A
American Journal of Obstetrics and Gynecology. 2002;187(4):1038-1045

Site: Maternity and Women's Health Hospital, Ankara, Turkey

Objective: To compare misoprostol, 600 mcg intrarectally, with conventional oxytocics in the management of the third stage.

Methods: After vaginal delivery, immediately after cord clamping, 1606 women were randomly assigned to 1 of 4 groups: (1) oxytocin + rectal misoprostol + placebo IM, (2) rectal misoprostol + placebo IM and placebo IV, (3) oxytocin + placebo IM + placebo rectal tablets, or (4) oxytocin + methylergometrine + placebo rectal tablets. All medications were applied by midwives, but the doctors involved in the study were blinded to the actual treatment.

Oxytocin was administered as 10 U/500 mL saline IV over 30 minutes. Two 200-mcg misoprostol tablets were inserted rectally, followed by 100 mcg 4- and 8-hours postpartum; 1 mL of methylergometrine was given IM.

The placenta was removed manually after 30 minutes. IM methylergometrine was given for persistent atony and bleeding after placental delivery. Blood was transfused in women with hemorrhage and hemoglobin less than 8 g/dL. Blood loss at delivery was estimated by weighing pads after the first hour. Postpartum hemorrhage (PPH) was defined as >/= 500 mL; severe PPH as >/= 1000 mL. The main outcomes were the incidence of PPH and the drop in hemoglobin concentration.

Results: The incidence of PPH was 9.8% in the misoprostol-only group, compared with 3.5% in the oxytocin-methylergonovine group (P = .001). Significantly more women needed additional oxytocin in the misoprostol-only group compared with the oxytocin-ergot group (8.3% vs 2.2%; P < .001). The primary outcome measures were similar in the misoprostol-only and oxytocin-only groups. Side effects such as shivering and hyperthermia (T >= 38°C) were significantly increased (P < .05) in both misoprostol groups compared with the oxytocin-alone or oxytocin-ergot groups.

Conclusions: Rectal misoprostol is significantly less effective than oxytocin plus methylergometrine for the prevention of PPH.

Commentary

It was only a matter of time before someone thought of using it for the prevention and treatment of postpartum hemorrhage. Given the availability of effective parenteral oxytocics (oxytocin, various ergot preparations, and the F2alpha prostaglandin Hemabate, Pharmacia), there is no great demand for a new product in this country. However, its low cost, stability, and ease of administration would be a boon in third-world countries -- where hemorrhage remains a major cause of maternal mortality. It is not surprising, therefore, that this study comes from Turkey.

This is a well-conceived and executed randomized controlled trial that could serve as a model in the United States. Rectal misoprostol was comparable in efficacy to IV oxytocin but less effective than oxytocin + methylergometrine. Compared with oxytocin alone, misoprostol was associated with increased shivering and hyperthermia. Gerstenfeld and Wing[1] found that rectal misoprostol was comparable to oxytocin in the short-term, but patients were more likely to need additional oxytocics.

Reference

 * Gerstenfeld TS, Wing DA. Rectal misoprostol versus intravenous oxytocin for the prevention of postpartum hemorrhage after vaginal delivery. Am J Obstet Gynecol. 2001;185:878-882.