Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

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

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 Overview

• Status: Completed
• Conditions: Abortion, Second Trimester
• Intervention / Treatment: Device: Dilapan-S; Device: Single Foley Balloon

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Dilapan-S; A number of Dilapan-S will be inserted for cervical preparation. The number will be determined by a standard protocol that is based on gestational age. The dilators will stay in until the next day prior to their procedure, or earlier if they fall out on their own.	Device: Dilapan-S; Dilapan S will be placed through the cervix on the day prior to the procedure
Experimental: Foley balloon; A Foley balloon will be inserted for cervical preparation and filled to 30mL of water or saline. The balloon will stay in until the next day prior to their procedure, or earlier if it falls out on its own.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	Time to speculum in to speculum out	Up to approximately 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Dilation	Measure the cervical dilation after removal of the Foley balloon or Dilapan-S	Beginning of the procedure (approximately 5 seconds to assess)

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB-63172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No