Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

NCT05099991 | Completed Results FDA Device

• 1 other identifier: IRB-63172
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Procedure Time

  Time to speculum in to speculum out

  Up to approximately 30 minutes

Secondary Outcomes (1)

• Cervical Dilation

  Beginning of the procedure (approximately 5 seconds to assess)

Study Arms (2)

Dilapan-S

PLACEBO COMPARATOR

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

Foley balloon

EXPERIMENTAL

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

Interventions

Single Foley Balloon DEVICE

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

Foley balloon

Dilapan-S DEVICE

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

Dilapan-S

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Liu SM, Henkel A, Meza P, Shorter JM, Cahill E, Blumenthal PD, Shaw KA. Comparing transcervical balloon with osmotic dilators for cervical preparation prior to procedural abortion: A noninferiority randomized trial. Contraception. 2024 Dec;140:110550. doi: 10.1016/j.contraception.2024.110550. Epub 2024 Jul 25.

  PMID: 39067560 DERIVED

Results Point of Contact

• Title: Research Team
• Organization: Stanford University

gynresearch@stanford.edu

(650) 497-5175

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 29, 2021
• Study Start: February 8, 2022
• Primary Completion: April 27, 2023
• Study Completion: April 28, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)