Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | January 2017 |
| Contact: | Dr. Matthew Reeves, MD MPH |
| Email: | matthew.reeves@medstar.net |
| Phone: | 1-202-877-7101 |
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
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.
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.
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
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
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.
We found this trial at
2
sites
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