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

Study on Outpatient Dilation and Evacuation (D&E) Procedures

Recruiting
18 years or above
All
Fase N/A
70 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dilation and Evacuation
  • Age: 18 years or above
  • Gender: All

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:

  • Medical conditions that require procedural management in the operating room
  • Preference for D&E procedure in the operating room

Updated on 30 Apr 2025. Study ID: NCT06964373

This study investigates outpatient dilation and evacuation (D&E) procedures for individuals within a specified gestational duration. Dilation and evacuation is a medical procedure used to terminate a pregnancy, typically performed in the second trimester. It involves dilating the cervix and removing pregnancy tissue using surgical instruments and suction.

Participants in the study will undergo the D&E procedure in an outpatient setting. They must follow specific guidelines, such as observing fasting rules before the procedure and arranging reliable transportation post-procedure.

  • Who can participate: Participants must be at least 18 years old, fluent in English or Spanish, and able to consent. They should be between 18 weeks 0 days and 19 weeks 6 days of gestation and able to follow fasting and transportation guidelines.
  • Study details: Participants will undergo an outpatient D&E procedure.

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