Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion
Not Applicable
Completed
- Conditions
- Abortion, Second Trimester
- Registration Number
- NCT05099991
- Lead Sponsor
- Stanford University
- Brief Summary
The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
Inclusion Criteria
- presenting to clinic for second trimester abortion at 18 to 23 weeks and 6 days gestation confirmed by ultrasound
- able to provide informed consent and comply with study protocol
- English or Spanish-speaking
- candidate for outpatient cervical preparation
Exclusion Criteria
- Anyone with an allergy to misoprostol, mifepristone or any study medication
- premature rupture of membranes
- intrauterine fetal demise
- placenta previa
- suspected abnormal placentation
- evidence of infection at the time of enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Procedure Time Up to approximately 30 minutes Time to speculum in to speculum out
- Secondary Outcome Measures
Name Time Method Cervical Dilation Beginning of the procedure (approximately 5 seconds to assess) Measure the cervical dilation after removal of the Foley balloon or Dilapan-S
Trial Locations
- Locations (1)
Stanford University
🇺🇸Palo Alto, California, United States
Stanford University🇺🇸Palo Alto, California, United States