Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol

MedStar Health

Status: Completed

Conditions: Second Trimester Abortions

Treatments: Procedure: Misoprostol administered buccally; Procedure: Misoprostol administered vaginally with Dilapan; Procedure: Misoprostol administered vaginally; Procedure: Misoprostol administered buccally with Dilapan

Study type: Interventional

Funder types: Other

Identifiers

NCT02363556

2014-110

Details and patient eligibility

About

This randomized controlled trial will use a 2 by 2 factorial design to assess methods of cervical preparation prior to Dilation and Evacuations (D&Es) at 14 0/7 to 19 6/7 weeks gestational age. In total, 160 woman will be randomized to misoprostol alone or Dilapan with misoprostol and separately randomized to buccal or vaginal administration of 400-mcg misoprostol. A total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40 buccal). Another 80 women will have Dilapan inserted and then use misoprostol (40 vaginal and 40 buccal). Four to six hours later, the Dilation and Evacuation (D&E) procedure will be performed.

Full description

The primary objective of the study is to compare the efficacy of same-day 400-mcg misoprostol alone to same-day Dilapan with 400-mcg misoprostol for cervical preparation prior to D&E at 14 0/7 to 19 6/7 weeks. Patients will first be randomized to misoprostol alone or misoprostol-Dilapan, and then separately randomized to use the misoprostol buccally or vaginally.

The primary outcome measure is total procedure time. Secondary outcomes include D&E procedure time, initial cervical dilation (measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure), patient-oriented outcomes (side effects of buccal and vaginal misoprostol), and patient acceptability and satisfaction.

The investigators have chosen a randomized controlled trial with a factorial design to be conducted at Washington Hospital Center and Planned Parenthood of Metropolitan Washington. A total up to 180 English speaking women will be enrolled in the study so that 160 will be randomized and receive study interventions. The study will enroll healthy women, over the age of 18, eligible for non-urgent D&E at 14 0/7 weeks to 19 6/7 weeks, confirmed by sonogram. The women will be randomized to receive either misoprostol alone or Dilapan with misoprostol. Women will then be randomized to receive 400-mcg of misoprostol either buccally or vaginally. Computer generated randomization will be utilized to assign treatment arms. Approximately 4-6 hours prior to procedure, women will be randomly assigned to one of the following treatment combinations:

1. Misoprostol 400-mcg vaginally
2. Misoprostol 400-mcg buccally
3. Dilapan insertion with 400-mcg misoprostol vaginally
4. Dilapan insertion with 400-mcg misoprostol buccally

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy pregnant women
• 18 years of age or older
• Eligible for non-urgent Dilation and Evacuations at 14 0/7 - 19 6/7 weeks gestation confirmed by sonogram.

Exclusion criteria

• Women who do not speak English.
• Fetal demise
• Intolerance, allergy or contraindication to misoprostol or Dilapan.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Misoprostol Alone

Experimental group

Description:

Subjects enrolled into this arm of the study will receive misoprostol 400-mcg only.

Treatment:

Procedure: Misoprostol administered vaginally

Procedure: Misoprostol administered buccally

Dilapan with Misoprostol

Experimental group

Description:

Subjects enrolled into this arm of the study will receive Dilapan with 400-mcg misoprostol.

Treatment:

Procedure: Misoprostol administered vaginally with Dilapan

Procedure: Misoprostol administered buccally with Dilapan