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 range18 Years

SexFEMALE

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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

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