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

NCT ID: NCT02363556

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-06-30

Brief Summary

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.

Detailed 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

Conditions

Second Trimester Abortions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Misoprostol Alone

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

Group Type: EXPERIMENTAL

Misoprostol administered vaginally

Intervention Type: PROCEDURE

Misoprostol administered buccally

Intervention Type: PROCEDURE

Dilapan with Misoprostol

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

Group Type: EXPERIMENTAL

Misoprostol administered vaginally with Dilapan

Intervention Type: PROCEDURE

Misoprostol administered buccally with Dilapan

Intervention Type: PROCEDURE

Interventions

Misoprostol administered vaginally

Intervention Type: PROCEDURE

Misoprostol administered buccally

Intervention Type: PROCEDURE

Misoprostol administered vaginally with Dilapan

Intervention Type: PROCEDURE

Misoprostol administered buccally with Dilapan

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Matthew Reeves

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Matthew Reeves, MD MPH

Role: PRINCIPAL_INVESTIGATOR

MedStar Washington Hospital Center & Planned Parenthood of Metropolitan Washington

Dr. Jamilah Shakir, MD MPH

Role: STUDY_CHAIR

Medstar Health Research Institute

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Planned Parenthood Metropolitan Washington

Silver Spring, Maryland, United States

Countries

United States

Other Identifiers

2014-110

Identifier Type: -

Identifier Source: org_study_id