Clinical trial NCT02363556: Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Second Trimester Abortions
Keywords: Cervical Dilation
Dilation and Evacuation
Misoprostol
Misoprostol-Dilapan
Abortion
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2015-02-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Total procedure time
timeFrame: 4-6hrs
Secondary outcomes:
measure: D&E procedure time
timeFrame: 0-60 mins
measure: Initial cervical dilation
timeFrame: 0-10 mins
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Silver Spring
country: United States
facility: Planned Parenthood Metropolitan Washington
state: Maryland
Study officials:
affiliation: MedStar Washington Hospital Center & Planned Parenthood of Metropolitan Washington
name: Dr. Matthew Reeves, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Dr. Jamilah Shakir, MD MPH
role: STUDY_CHAIR
References: