A randomized study comparing rectally administered misoprostol versus Syntometrine combined with an oxytocin infusion for the cessation of primary post partum hemorrhage.

BACKGROUND: Post partum hemorrhage is a major cause of maternal death, particularly in developing countries, and most cases are due to an atonic uterus. Hemorrhage can occur despite active management of the third stage of labor. Presently, misoprostol (Cytotec, Searle Pharmaceuticals) is the only thermostable uterotonic agent potentially available which would be economically beneficial for developing countries where refrigeration of drugs poses a problem. The objective of the study was to compare intra-muscular Syntometrine (Sandoz Pharmaceuticals) (ampoule=5 iu oxytocin and 500 mcg ergometrine maleate) plus Syntocinon (Sandoz Pharmceuticals) (10 iu oxytocin diluted in 500 ml normal saline) intravenous infusion versus 800 mcg misoprostol per rectum for treatment of primary post partum hemorrhage in a developing country.
METHODS: Randomized single blinded two-center study, set in both a township and teaching hospital in South Africa. Sixty-four women with primary post partum hemorrhage due to an atonic uterus were recruited. The primary outcome measure was whether the hemorrhage ceased within 20 minutes of administering the first line treatment, once hemorrhage was clinically recognized.
RESULTS: There was a 28.1% difference between the misoprostol arm and the Syntometrine and Syntocinon arm (p=0.01). This result had a greater than 80% power. Misoprostol performed better.
CONCLUSION: 800 mcg misoprostol per rectum is effective at treating primary post partum hemorrhage.

RCT Entities:   Population Interventions Outcomes