Abortion, Second Trimester Clinical Trial
Official title:
A Randomized Double-blinded Comparison of 24-hour Interval-Mifepristone and Buccal Misoprostol Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation in Second-Trimester Surgical Abortion
Verified date | June 2018 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal misoprostol for cervical preparation for second trimester dilation and evacuation (D&E).
Status | Completed |
Enrollment | 70 |
Est. completion date | August 1, 2017 |
Est. primary completion date | August 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - The study will enroll healthy English or Spanish-speaking women, over 18 years of age, eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by sonogram, and willing/able to undergo informed consent. Exclusion Criteria: - Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy, intolerance, allergy or contraindication to mifepristone or misoprostol |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure Time | Time from initial uterine instrumentation to speculum out | At end of procedure | |
Secondary | Cervical Dilation | Pratt Dilator initially accepted without resistance starting from 65 and working down | At end of procedure |
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