CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Single Foley Balloon +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05099991
NCT05099991N/ACompleted
CompareCT.gov

Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion: a Non-Inferiority Randomized Trial

Stanford University·interventional·Posted Oct 29, 2021·Updated Apr 18, 2024

In Brief

A clinical study evaluating Single Foley Balloon and Dilapan-S for Abortion, Second Trimester. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbortion, Second Trimester
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 29, 2021
Enrollment StartFeb 8, 2022
Primary CompletionApr 27, 2023
Study CompletionApr 28, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.7 years ago

Interventions

Single Foley Balloondevice

Foley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure

Dilapan-Sdevice

Dilapan S will be placed through the cervix on the day prior to the procedure