Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06964373

Cervical Ripening Balloons for Same-Day Cervical Prep

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dilation and Evacuation Dilatation, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location status: Recruiting

Location contact

Cervical Ripening Balloon Study Coordinator

CONTACT

[email protected]

505-205-4118

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical Ripening Balloon

Device

30 milliliter Foley balloon

Osmotic Dilators

Device

Dilapan-S

Primary outcomes

  1. D&E procedure length (minutes)

    Time frame: during procedure

    From insertion of first instrument to removal of speculum

Secondary outcomes

  1. Starting dilation (French gauge)

    Time frame: during procedure

    Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)

  2. Additional dilation (French gauge)

    Time frame: during procedure

    Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)

  3. Estimated blood loss (milliliters)

    Time frame: during procedure

    Amount of blood loss, measured in milliliters throughout the procedure

  4. Additional sedation medication administered

    Time frame: during procedure

    yes/no

  5. Pain (Visual Analog Scale)

    Time frame: during procedure

    10 point visual analog scale with values from 0-10, with 0 being "No pain" and 10 being "Worst possible pain." Electronic slider measure so participants can specify up to 0.001 value.

  6. Administration of uterotonic medications

    Time frame: during procedure

    yes/no

  7. Cervical laceration

    Time frame: during procedure

    yes/no

  8. Estimated blood loss > 500 milliliters

    Time frame: From enrollment to 24 hours after enrollment

    yes/no

  9. Hospital transfer

    Time frame: From enrollment to 24 hours after enrollment

    yes/no

  10. Feasibility of cervical preparation (physician-reported)

    Time frame: From enrollment to 24 hours after enrollment

    Yes/ No: "Is this type of cervical prep feasible for future patients" and qualitative free-text responses

  11. Likelihood to recommend cervical preparation (participant-reported)

    Time frame: From enrollment to 24 hours after enrollment

    Modified Likert scale: Very unlikely, Somewhat unlikely, Neither likely nor unlikely, Somewhat likely, Very likely

  12. Acceptability of cervical preparation (physician-reported)

    Time frame: From enrollment to 24 hours after enrollment

    Yes/ No: "Is this type of cervical prep acceptable for future patients" and qualitative free-text responses

  13. Satisfaction with level of pain management (participant-reported)

    Time frame: From enrollment to 24 hours after enrollment

    Yes/ No: "Are you satisfied with your level of pain management..." and qualitative free-text responses

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination

Acronym: CRB

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 9, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.