Status:
TERMINATED
Same-day Dilapan-S With Adjunctive Misoprostol
Lead Sponsor:
University of Pittsburgh
Conditions:
Therapeutic Abortion
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Cervical preparation before second trimester dilation and evacuation (D\&E) reduces risks and complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied for cervical...
Detailed Description
Dilation and evacuation (D\&E) is commonly performed for second trimester abortions and management of second trimester intrauterine fetal demise (IUFD). Cervical preparation prior to second trimester ...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years (no upper age limit)
- Gestational age between 16+0 and 20+6 weeks gestation on day of D\&E with confirmation of gestational age by ultrasound
- Desires D\&E for termination of pregnancy or for fetal demise
- Able to provide written informed consent
- Able to comply with study procedures
- English-speaking
Exclusion
- Known allergy or contraindication to misoprostol
- Pregnancy with a multiple gestation
- Known bleeding disorder or current anticoagulation therapy (within one month of procedure)
- Active bleeding or hemodynamically unstable at enrollment
- Signs of chorioamnionitis or clinical infection at enrollment
- Signs of spontaneous labor or cervical insufficiency at enrollment
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01818414
Start Date
October 1 2013
End Date
April 1 2014
Last Update
February 28 2017
Active Locations (2)
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1
Planned Parenthood of Western Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
2
Univeristy of Pittsburgh, Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213