Status:
COMPLETED
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
Lead Sponsor:
Boston University
Collaborating Sponsors:
Society of Family Planning
Conditions:
Cervical Preparation
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours ...
Eligibility Criteria
Inclusion
- Women 18-50 years of age undergoing surgical termination of pregnancy
- English or Spanish speaking
- Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
- Eligible for a dilation and evacuation abortion with local anesthesia and sedation
- Ultrasound for dating purposes done within the last two weeks
Exclusion
- Intrauterine infection
- Fetal demise
- Ruptured membranes
- Multiple gestation
- Uterine anomaly or significant distortion of the uterus with fibroids
- BMI greater than 45
- Inability to place osmotic dilators
- Active substance abuse or intoxication
- Adrenal failure, chronic corticosteroid use, anticoagulant usage
- Severe cervicitis, until treated and resolved
- Prior Cesarean section
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01436279
Start Date
July 1 2011
End Date
August 1 2013
Last Update
June 14 2017
Active Locations (1)
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1
Boston University
Boston, Massachusetts, United States, 02130