Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester

This project is a placebo-controlled, double-blinded randomized controlled trial comparing the effect of misoprostol 400mcg buccally to placebo on blood loss in second trimester surgical abortion between 16-21 weeks gestation. The probability of group assignment is 50% with half of the women randomized to misoprostol and half to placebo (folic acid 1 mg).

Folic acid was chosen at the placebo as it looks similar to misoprostol, and when it is held in the cheek it has very little taste, similar to misoprostol. A compounded placebo that was tasteless had a very different appearance and was not suitable as a control.

Consent will be obtained after consent for the abortion has been completed and counseling and explanation of the abortion has been completed. Consent may be obtained before the abortion procedures have begun of the day prior to abortion (osmotic dilator placement and induction of fetal demise if appropriate), or after these procedures have been completed. No study procedures take place on the day prior to abortion.

On the day of the abortion, 1 hour prior to the procedure, the following study procedures will be conducted. Women will be given the study medication, which consists of two tablets of either misoprostol 200 mcg (400 mcg total) or placebo (folic acid 2 mg). The medication will be dispensed from opaque sequentially numbered vials so that double-blinding is maintained. The subject will be asked questions about symptoms prior to administration of the study medication. She will then hold the medication buccally (in her cheek) for 20 minutes and then swallow any remaining tablet. Immediately prior to the abortion, the subject will be asked about her symptoms again.

The abortion will commence 1 hour after administration of the study medication. The following study procedure will be done at the start of the abortion. The amount of cervical dilation will be measured by cervical dilators, starting with the largest dilator and progressively using smaller dilators until the largest one that will pass is determined. This generally takes less than 30 seconds.