Background. Manual removal of placenta is performed in 13 of cases, and whilst a well established and relatively safe procedure, it is not without complications, which include infection, hemorrhage, uterine rupture, and occasional maternal death. Methods.
A three-arm randomized controlled trial of 50 IU Syntocinon (in 30 ml N saline) versus 800 mcg misoprostol (in 30 ml N saline) versus 30 ml N saline alone (control), injected into the placental bed via the umbilical vein using the Pipingas method.
A group sequential research model (triangular test: PEST4) was adopted to minimize the sample size, as retained placenta is a relatively uncommon condition. Results. No significant difference in the rate of manual removal was observed between the control and Syntocinon groups. On triggering the automatic stopping rule for this arm of the trial all subsequent cases recruited were allocated to receive either Syntocinon or misoprostol.
After a total of 54 cases a significant reduction in manual removal of placenta was observed in the misoprostol group, triggering the automatic stopping rule and terminating the trial. Conclusion. Misoprostol (800 mcg) dissolved in 30 ml N saline and administered by intraumbilical injection using the Pipingas technique significantly reduces the need for manual removal for retained adherent placenta, whereas Syntocinon has similar effectiveness to injection of N saline alone.