ClinicalTrials.gg
Sign In
RecruitingNCT06964373CRBUpdated Oct 13, 2026

Cervical Ripening Balloons for Same-Day Cervical Prep

An interventional study of Cervical Ripening Balloon and Osmotic Dilators in Dilation and Evacuation, sponsored by University of New Mexico. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Updated Oct 13, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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
02

Conditions studied

  • Dilation and Evacuation
03

In context

Dilatation, Pathologic

120 studies on the registry are indexed under Dilatation, Pathologic; 18 are open to participants now.

This study's planned enrollment of 70 is below the median of 82 across 84 interventional studies indexed under Dilatation, Pathologic.

Browse Dilatation, Pathologic studies →

Lead sponsor

University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Browse University of New Mexico studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Medical conditions that require procedural management in the operating room
  • Preference for D\&E procedure in the operating room
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Cervical Ripening Balloon

    Device: Cervical Ripening Balloon

  • Active comparator
    Osmotic Dilators

    Device: Osmotic Dilators

Interventions

  • DeviceCervical Ripening Balloon

    30 milliliter Foley balloon

  • DeviceOsmotic Dilators

    Dilapan-S

06

What researchers measure

Primary outcomes

  1. D&E procedure length (minutes)

    From insertion of first instrument to removal of speculum

    Time frame: during procedure

Secondary outcomes

  1. Starting dilation (French gauge)

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

    Time frame: during procedure

  2. Additional dilation (French gauge)

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

    Time frame: during procedure

  3. Estimated blood loss (milliliters)

    Amount of blood loss, measured in milliliters throughout the procedure

    Time frame: during procedure

  4. Additional sedation medication administered

    yes/no

    Time frame: during procedure

  5. Pain (Visual Analog Scale)

    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.

    Time frame: during procedure

  6. Administration of uterotonic medications

    yes/no

    Time frame: during procedure

  7. Cervical laceration

    yes/no

    Time frame: during procedure

  8. Estimated blood loss > 500 milliliters

    yes/no

    Time frame: From enrollment to 24 hours after enrollment

  9. Hospital transfer

    yes/no

    Time frame: From enrollment to 24 hours after enrollment

  10. Feasibility of cervical preparation (physician-reported)

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

    Time frame: From enrollment to 24 hours after enrollment

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

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

    Time frame: From enrollment to 24 hours after enrollment

  12. Acceptability of cervical preparation (physician-reported)

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

    Time frame: From enrollment to 24 hours after enrollment

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

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

    Time frame: From enrollment to 24 hours after enrollment

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for May 2027, 25 months after the start.

Of 27 interventional studies with no phase under Dilatation, Pathologic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 25 months is close to that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: primary completion Aug 2026 → May 2027 and completion Jul 2027 → Dec 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2025
First posted
May 9, 2025
StartActual
Apr 8, 2025
Primary completionEst.
May 31, 2027was Aug 2026
CompletionEst.
Dec 31, 2027was Jul 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 30, 2026→May 31, 2027
Oct 13, 2026
Study completion
Jul 31, 2027→Dec 31, 2027
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Primary completion Aug 30, 2026→May 31, 2027
    Study completion Jul 31, 2027→Dec 31, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06964373
Lead sponsor
University of New Mexico
Responsible party
Sponsor
First posted
May 9, 2025
Start date
Apr 8, 2025
Primary completion
May 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 13, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dilatation, Pathologic →

Other studies from this sponsor

University of New Mexico →

Start the discussion