Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

Sponsor

Stanford University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05099991

Collaborator

(none)

Enrollment

Location

Arms

15.7

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abortion, Second Trimester	Device: Single Foley Balloon Device: Dilapan-S	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 8, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Procedure time [Approximately 12 minutes]
Time to speculum in to speculum out

Secondary Outcome Measures

Cervical dilation [Beginning of the procedure (approximately 5 seconds to assess)]
Measure the cervical dilation after removal of the Foley balloon or Dilapan-S

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304

Sponsors and Collaborators

Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT05099991

Other Study ID Numbers:

IRB-63172

First Posted:

Oct 29, 2021

Last Update Posted:

May 10, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of May 10, 2022