CompletedNot Applicable

Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

United States32 participantsStarted 2022-02-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Procedure Time

Timeframe: Up to approximately 30 minutes

Trial details

NCT IDNCT05099991

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-27

Results submitted2024-03-22

View on ClinicalTrials.gov More Abortion, Second Trimester trials