Foley catheter versus laminaria for cervical preparation prior to second trimester dilation and evacuation: Open label a non-inferiority randomized trial
Phase 4
- Conditions
- Abortion
- Registration Number
- PACTR202408852551318
- Lead Sponsor
- St. Paul Institute for Reproductive Health and Rights
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 128
Inclusion Criteria
Women undergoing second trimester D&E
-Gestational age at 16-22 weeks
-Volunteering to participate in the study
Elective D&E procedure
Exclusion Criteria
-Incomplete abortion
-Molar pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean dilation and evacuation- D&E -procedure time (in minutes) after overnight laminaria or Foley catheter placement
- Secondary Outcome Measures
Name Time Method requirement of additional doses of misoprostol ( 2 or more doses) , Foley or Laminaria insertion to D&E time, D&E complications ( hemorrhage, cervical tear, infection, uterine perforation , failed cervical preparation, and incomplete abortion ), and patient acceptability of the cervical preparation methods