Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-31 @ 6:42 AM
Study NCT ID:
NCT02363556
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: