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Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

NCT05099991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-04-18

Study results available
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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.

Conditions

  • Abortion, Second Trimester

Interventions

DEVICE

Single Foley Balloon

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

DEVICE

Dilapan-S

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2023-04-27
Completion
2023-04-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099991 on ClinicalTrials.gov