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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Cervical Ripening Balloon, Osmotic Dilators?

Research shows that mechanical methods like cervical ripening balloons are effective for softening and opening the cervix before labor, similar to other methods like prostaglandins, and they are simple, low-cost, and have fewer side effects. ^{1 2 3 4 5}

Is the use of cervical ripening balloons and osmotic dilators generally safe for humans?

Cervical ripening balloons and osmotic dilators are generally considered safe for use in humans, with minor complications like vaginal bleeding occurring in less than 2% of cases. Serious infections are uncommon, and while there is a risk of devices getting trapped or fragmenting, preventative measures can help reduce these risks. ^{1 2 4 6 7}

How is the treatment with cervical ripening balloons and osmotic dilators different from other treatments for cervical dilation and evacuation?

The use of cervical ripening balloons and osmotic dilators is unique because it is a non-drug, mechanical method that works by physically expanding as they absorb fluid, which helps to soften and open the cervix. This approach is simple, low-cost, and avoids systemic side effects compared to pharmacological methods like prostaglandins or oxytocin. ^{1 2 4 8 9}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

A Review of the Mechanism of Action and Clinical Applications of Osmotic Dilators for Cervical Ripening in the Induction of Labor and in Gynecology Procedures. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term: A Randomized Controlled Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of two mechanical devices for cervical ripening: a prospective quasi-randomized trial. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Ripening of the unfavorable cervix with extraamniotic catheter balloon: clinical experience and review. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Double-balloon catheter versus prostaglandin for cervical ripening to induce labor after previous cesarean delivery. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Complications of osmotic dilators. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening - an Evidence-Based Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Acute complications with same-day versus overnight cervical preparation before dilation and evacuation at 14 to 16 weeks. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial. [2021]