Dilation and EvacuationCRBNCT06964373
Cervical Ripening Balloons for Same-Day Cervical Prep
A study testing Cervical Ripening Balloon and Osmotic Dilators in people with Dilation and Evacuation, run by University of New Mexico at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dilation and Evacuation
- What is being tested?
- Cervical Ripening Balloon and Osmotic Dilators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical conditions that require procedural management in the operating room
- Preference for D\&E procedure in the operating room
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87106
Cervical Ripening Balloon Study Coordinator, 505-205-4118, HSC-FamilyPlanningResearch@salud.unm.edu
About this study
Official title: Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
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?
Read more
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
- Conditions
- Dilation and Evacuation
- Being tested
- Cervical Ripening Balloon, Osmotic Dilators
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Ripening BalloonDevice
30 milliliter Foley balloon
Osmotic DilatorsDevice
Dilapan-S
| Study group | Role | What they receive |
|---|---|---|
| Cervical Ripening Balloon | Experimental | Not described Receives: Device: Cervical Ripening Balloon |
| Osmotic Dilators | Active comparator | Not described Receives: Device: Osmotic Dilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
D&E procedure length (minutes)
From insertion of first instrument to removal of speculum
Measured: during procedure
Secondary outcomes (13)
Starting dilation (French gauge)
Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)
Measured: during procedure
Additional dilation (French gauge)
Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)
Measured: during procedure
Estimated blood loss (milliliters)
Amount of blood loss, measured in milliliters throughout the procedure
Measured: during procedure
Additional sedation medication administered
yes/no
Measured: during procedure
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.
Measured: during procedure
Administration of uterotonic medications
yes/no
Measured: during procedure
Cervical laceration
yes/no
Measured: during procedure
Estimated blood loss > 500 milliliters
yes/no
Measured: From enrollment to 24 hours after enrollment
Hospital transfer
yes/no
Measured: From enrollment to 24 hours after enrollment
Feasibility of cervical preparation (physician-reported)
Yes/ No: "Is this type of cervical prep feasible for future patients" and qualitative free-text responses
Measured: From enrollment to 24 hours after enrollment
Likelihood to recommend cervical preparation (participant-reported)
Modified Likert scale: Very unlikely, Somewhat unlikely, Neither likely nor unlikely, Somewhat likely, Very likely
Measured: From enrollment to 24 hours after enrollment
Acceptability of cervical preparation (physician-reported)
Yes/ No: "Is this type of cervical prep acceptable for future patients" and qualitative free-text responses
Measured: From enrollment to 24 hours after enrollment
Satisfaction with level of pain management (participant-reported)
Yes/ No: "Are you satisfied with your level of pain management..." and qualitative free-text responses
Measured: From enrollment to 24 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start8 Apr 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilation and EvacuationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964373
- Sponsor's protocol ID
- 24-493
- Acronym
- CRB
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
- ClinicalTrials.gov ID
- NCT06964373
- Acronym / sponsor ID
- CRB / 24-493
- Conditions
- Dilation and Evacuation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Ripening Balloon | Experimental | Device: Cervical Ripening Balloon |
| Osmotic Dilators | Active comparator | Device: Osmotic Dilators |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Medical conditions that require procedural management in the operating room
- Preference for D\&E procedure in the operating room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Ripening Balloon30 milliliter Foley balloon | Device | Cervical Ripening Balloon |
| Osmotic DilatorsDilapan-S | Device | Osmotic Dilators |
Primary outcome
D&E procedure length (minutes)
Time frame: during procedure
From insertion of first instrument to removal of speculum
13 secondary outcomes
Starting dilation (French gauge)
Time frame: during procedure
Additional dilation (French gauge)
Time frame: during procedure
Estimated blood loss (milliliters)
Time frame: during procedure
Additional sedation medication administered
Time frame: during procedure
Pain (Visual Analog Scale)
Time frame: during procedure
Administration of uterotonic medications
Time frame: during procedure
Cervical laceration
Time frame: during procedure
Estimated blood loss > 500 milliliters
Time frame: From enrollment to 24 hours after enrollment
Hospital transfer
Time frame: From enrollment to 24 hours after enrollment
Feasibility of cervical preparation (physician-reported)
Time frame: From enrollment to 24 hours after enrollment
Likelihood to recommend cervical preparation (participant-reported)
Time frame: From enrollment to 24 hours after enrollment
Acceptability of cervical preparation (physician-reported)
Time frame: From enrollment to 24 hours after enrollment
Satisfaction with level of pain management (participant-reported)
Time frame: From enrollment to 24 hours after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of New Mexico
Albuquerque, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Ripening Balloon and Osmotic Dilators in people with Dilation and Evacuation, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
D&E procedure length (minutes) (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.