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Completed

NCT Number: NCT02363556

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

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.

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Key information

Conditions

Second Trimester Abortions Dilatation, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States

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About this study

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:

  • Misoprostol 400-mcg vaginally
  • Misoprostol 400-mcg buccally
  • Dilapan insertion with 400-mcg misoprostol vaginally
  • Dilapan insertion with 400-mcg misoprostol buccally

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol administered vaginally

Procedure

Misoprostol administered buccally

Procedure

Misoprostol administered vaginally with Dilapan

Procedure

Misoprostol administered buccally with Dilapan

Procedure

Primary outcomes

  1. Total procedure time

    Time frame: 4-6hrs

    Total procedure time is defined as the time required for dilator insertion plus the D&E time.

Secondary outcomes

  1. D&E procedure time

    Time frame: 0-60 mins

  2. Initial cervical dilation

    Time frame: 0-10 mins

    Measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

A Factorial-Design Randomized Controlled Trial Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol for Same-Day Cervical Preparation Prior to Dilation & Evacuation

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 16, 2015
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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