Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

Abortion, Second Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05099991
• Other study ID #: IRB-63172
• Status: Completed
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 28, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Second Trimester

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Time	Time to speculum in to speculum out	Up to approximately 30 minutes
Secondary	Cervical Dilation	Measure the cervical dilation after removal of the Foley balloon or Dilapan-S	Beginning of the procedure (approximately 5 seconds to assess)