N/A
N=32
Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion
Abortion, Second Trimester
Bottom Line
View on ClinicalTrials.gov: NCT05099991 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Procedure Time — 22.4; 22.6 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single Foley Balloon (Device); Dilapan-S (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Time |
22.4; 22.6 | — |
| SECONDARY Cervical Dilation |
0; 2; 0; 4; 4; 3 | 0.07 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05099991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.