Cervical Ripening Balloons for Same-Day Cervical Prep (CRB)

University of New Mexico (UNM)

Status

Enrolling

Conditions

Dilation and Evacuation

Treatments

Device: Cervical Ripening Balloon

Device: Osmotic Dilators

Study type

Interventional

Funder types

Other

Identifiers

NCT06964373

24-493

Details and patient eligibility

About

The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D&E). The main questions it aims to answer are:

Is cervical preparation with cervical ripening balloon for same-day outpatient D&E non-inferior to cervical preparation with osmotic dilators?
How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D&E?
How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D&E?

Participants will:

Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group)
Complete two surveys, one about the cervical preparation and one about the D&E procedure

Enrollment

70 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Individuals who desire outpatient dilation and evacuation (D&E)
At least 18 years of age
Able and willing to consent
Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound
Able to read and understand English or Spanish
Able to obtain reliable post-procedure transportation
Able to observe fasting guidelines of 6 hours prior to the D&E procedure

Exclusion criteria