Clinical trial NCT01818414
Conditions: Therapeutic Abortion
Keywords: Misoprostol administration & dosage Abortion techniques Abortion Induced methods Dilatation and Curettage
Sponsor: University of Pittsburgh
Start date: 2013-10-01; Completion date: 2014-04-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cervical preparation before second trimester dilation and evacuation (D\&E) reduces risks and complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied for cervical preparation. However, the optimal method for cervical preparation, especially for D\&E procedures that occur on the same day as cervical preparation, is not known. This study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical preparation for same-day D\&E between 16+0 and 20+6 weeks gestation.

HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours prior to D\&E as an adjunct to cervical preparation with Dilapan-S will decrease operative time for same-day D\&E performed between 16+0 and 20+6 weeks.

Detailed description:
Dilation and evacuation (D\&E) is commonly performed for second trimester abortions and management of second trimester intrauterine fetal demise (IUFD). Cervical preparation prior to second trimester D\&E increases safety.

Osmotic cervical dilators and prostaglandin analogs are used widely for cervical preparation before second trimester D\&E. Osmotic dilators are placed into the cervical canal, radially expand as they absorb moisture and decrease the risk of cervical injury during D\&E. Laminaria tents are the most commonly used osmotic dilator for D\&E cervical preparation but require N18 h to reach maximum diameter. Dilapan-S®, a synthetic osmotic cervical dilator, has a significant dilation effect 2 h after placement with the majority of expansion occurring in 4-6 h according to the manufacturer.

Misoprostol is the most commonly used pharmacologic cervical preparation for D\&E with duration of action between 2 and 4 h after administration. Multiple studies demonstrate the safety of misoprostol before early second trimester abortion. One prospective and four retrospective studies suggest that same-day cervical preparation with Dilapan-S and/or misoprostol for second trimester D\&E through 20 weeks is safe and effective. Misoprostol may be less effective when used alone compared to overnight osmotic dilators for cervical preparation later in the second trimester but has adjunctive benefit on cervical dilation and procedure time when used with overnight osmotic dilators between 16 and 24 weeks. The effect appears most pronounced at N19 weeks gestation. No prospective studies have been published examining misoprostol as an adjunct to osmotic dilators for cervical preparation for same-day D\&E.

Administration of adjunctive misoprostol with Dilapan-S has the potential to effectively prepare the cervix and decrease operative time for same-day D\&E. We compared cervical preparation with Dilapan-S with and without adjunctive buccal misoprostol for same-day D\&E between 16 0/7 and 20 6/7 weeks gestation.

Arms: arm 1: Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S. arm 2: Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S
Interventions: intervention 1: Misoprostol intervention 2: Folic Acid
Intervention descriptions: intervention 1: 400 mcg of buccal misoprostol, 3 hours prior to planned D\&E intervention 2: 4 mg of buccal folic acid, 3 hours prior to planned D\&E

Protocol documents: