Cervical Ripening Balloons for Same-Day Cervical Prep
ConditionDilation and Evacuation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of New Mexico
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Medical conditions that require procedural management in the operating room
Preference for D&E procedure in the operating room
Trial design
Treatments tested in this trial
- Cervical Ripening Balloon
- Osmotic Dilators
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov