Cervical Ripening Balloons for Dilation and Evacuation

(CRB Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Operating room preference, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a cervical ripening balloon (a small inflatable device) compared to traditional osmotic dilators (devices that absorb moisture to expand) for preparing the cervix before a same-day outpatient dilation and evacuation (D&E) procedure. The study evaluates the effectiveness, safety, and patient satisfaction with the balloon method. Participants will receive either the balloon or the usual dilators and will share their experiences through surveys. This trial suits those planning a D&E procedure between 18 and 19 weeks of pregnancy and who can manage transportation and fasting requirements. As an unphased trial, it offers participants the chance to contribute to important research that could improve future D&E procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the cervical ripening balloon is safe for cervical preparation before same-day outpatient D&E?

Research has shown that the cervical ripening balloon, similar to the Foley balloon, is generally safe for preparing the cervix. One review found the Foley balloon effective and safe for cervical preparation before procedures like dilation and evacuation (D&E). Another study found that a double-balloon catheter was safe for starting labor, although it was not superior to other methods. This suggests that a cervical ripening balloon is likely well-tolerated.

Osmotic dilators are also commonly used for cervical preparation and are considered safe. They have been a standard part of many procedures.

In summary, both the cervical ripening balloon and osmotic dilators have demonstrated safety in past uses. For those considering joining this trial, these treatments have a history of being well-tolerated in similar procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which typically involves osmotic dilators to prepare the cervix for procedures, the cervical ripening balloon offers a mechanical approach that may reduce the need for medication. This balloon method is unique because it physically expands the cervix, which can potentially shorten preparation time and decrease side effects associated with chemical dilators. Researchers are excited about this technique as it might provide a more comfortable and quicker option for patients needing cervical dilation.

What evidence suggests that this trial's treatments could be effective for cervical preparation before same-day outpatient D&E?

This trial will compare the effectiveness of cervical ripening balloons with osmotic dilators for preparing the cervix before procedures like dilation and evacuation (D&E). Research has shown that cervical ripening balloons effectively prepare the cervix, and studies indicate they can work as well as osmotic dilators. Both methods soften and open the cervix, making the procedure easier and faster. Evidence suggests that balloon catheters are as effective as some drugs in speeding up labor, similar to their function in D&E. People generally find balloons acceptable for cervical preparation. Overall, the cervical ripening balloon is a promising option for this purpose. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals needing cervical preparation before a same-day outpatient dilation and evacuation (D&E) procedure. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

Able to observe fasting guidelines of 6 hours prior to the D&E procedure

Able and willing to consent

Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound

Exclusion Criteria

I prefer to have a D&E procedure in the operating room.

I need a medical procedure that must be done in an operating room.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Cervical Preparation

Participants undergo cervical preparation with either a cervical ripening balloon or osmotic dilators

Same-day

1 visit (in-person)

Dilation and Evacuation (D&E) Procedure

Participants undergo the D&E procedure following cervical preparation

Same-day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

24 hours

1 follow-up contact (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

• Cervical Ripening Balloon
• Osmotic Dilators

Trial Overview The study compares two methods of cervical prep: an experimental group using a cervical ripening balloon (Foley balloon) versus the usual care group using osmotic dilators. It aims to assess non-inferiority, feasibility, safety, and acceptability of the balloon method with participant surveys.

How Is the Trial Designed?

Group I: Cervical Ripening Balloon Experimental Treatment 1 Intervention

Group II: Osmotic Dilators Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6109826/

Patient satisfaction with the cervical ripening balloon as a ... Evidence has shown that balloon catheters are as effective as prostaglandins (PGE) in achieving vaginal delivery within 24 hours of the start of induction ...

2. aafp.org aafp.org/pubs/afp/issues/2022/0200/p177.html

Cervical Ripening and Induction of Labor Some evidence shows that the use of nonpharmacologic approaches such as osmotic dilators and cervical ripening balloons reduce time to delivery. The effect of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933324000442

Randomized control trial comparing hygroscopic cervical ... This study aimed to demonstrate equivalent efficacy between synthetic hygroscopic dilators and the single-balloon catheter for outpatient cervical ripening.

4. ajog.org ajog.org/article/S0002-9378(19)30036-5/fulltext

A randomized controlled trial of Dilapan-S vs Foley balloon ... We found that pregnancies undergoing cervical ripening with DS was noninferior to FB in achieving vaginal delivery. While the rate of vaginal ...

5. journals.lww.com journals.lww.com/greenjournal/fulltext/2025/07000/cervical_ripening_in_pregnancy__acog_clinical.30.aspx

Cervical Ripening in Pregnancy - Obstetrics & Gynecology The purpose of this document is to review current methods for cervical ripening and to summarize the effectiveness of these approaches based ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9450369/

Safety and efficacy of double-balloon catheter for cervical ... Double-balloon catheter did not show superiority when compared with other single method in primary and secondary outcomes of labor induction.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782421002146

Foley catheter and misoprostol for cervical preparation ... Our chart review showed that an intracervical Foley balloon and serial misoprostol are effective and safe for cervical preparation before second-trimester D&E ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07200115

RCT of Cervical Ripening Double Ballon Catheter Prior to ... The purpose of this study is to determine whether the overnight use of an FDA-cleared CRDB catheter is superior to the use of overnight ...

9. ajog.org ajog.org/article/S0002-9378(23)00081-9/abstract

Methods for the induction of labor: efficacy and safety The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of ...

10. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-020-03513-7

Induction of labour in mid-trimester pregnancy using double ... This study aims to evaluate the efficacy and safety of the induction of labour in mid-trimester pregnancy using a double-balloon catheter (DBC) within 12 h ...