Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

Not Applicable

Completed

• Conditions: Abortion, Second Trimester
• Interventions: Device: Dilapan-S; Device: Single Foley Balloon

• Registration Number: NCT05099991
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-17
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-29
• Study Start: 2022-02-08
• Primary Completion: 2023-04-27
• Study Completion: 2023-04-28
• Status Verified: 2024-03
• Results First Submitted: 2024-03-22
• Results First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Results First Posted: 2024-04-18
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dilapan-S	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.
Foley balloon	Single 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.

Primary Outcome Measures

Name	Time	Method
Procedure Time	Up to approximately 30 minutes	Time to speculum in to speculum out

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States