Cervical Ripening Double Balloon Catheter for Cervical Ripening

(CRDB RCT Trial)

Overseen By Yale Family Planning

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Multiple pregnancy, Infection, Bleeding, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Cervical Ripening Double Balloon (CRDB) catheter, a special type of thin tube, is more effective than usual osmotic dilators for preparing the cervix before a dilation and evacuation (D&E) procedure. Although the CRDB catheter is already approved for assisting with labor at full term, this study tests its use in the second trimester. Women between 19 and 23 weeks pregnant, planning a D&E, and residing in Connecticut may qualify for this trial.

As an unphased study, this trial allows participants to contribute to important research that could enhance medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a contraindication (a medical reason not to use) to medications used during standard cervical preparation, you may not be eligible to participate.

What prior data suggests that the Cervical Ripening Double Balloon (CRDB) Catheter is safe for cervical dilation?

Research has shown that the Cervical Ripening Double Balloon (CRDB) Catheter is generally safe for use. Studies indicate that this catheter carries a low risk of complications during labor induction. The primary concern is a small chance of infection, though this is uncommon. The FDA has approved the CRDB Catheter to help open the cervix (the lower part of the uterus) before childbirth at full term. This approval suggests it is well-tolerated for similar uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cervical Ripening Double Balloon (CRDB) Catheter is unique because it offers a mechanical method to help prepare the cervix for childbirth. Unlike current options like osmotic dilators, which absorb moisture to expand and dilate the cervix gradually, the CRDB Catheter uses a dual-balloon system to apply direct pressure, potentially speeding up the ripening process. Researchers are excited about this treatment as it may provide a more controlled and faster approach to cervical ripening, potentially leading to a smoother labor process.

What evidence suggests that the Cervical Ripening Double Balloon Catheter is effective for cervical dilation?

Studies have shown that the double-balloon catheter, which participants in this trial may receive, effectively prepares the cervix for labor by softening and opening it. In one study, 91% of women achieved successful vaginal births using this method, with low risks of infection and bleeding. Although it hasn't been proven superior to other methods, many doctors find it effective. Typically used at the end of pregnancy, the double-balloon catheter works similarly if used earlier, suggesting it might also help open the cervix in the second trimester. Another treatment option in this trial is the use of osmotic dilators, serving as an active comparator. ^{1 6 7 8 9}

Who Is on the Research Team?

Tessa Madden, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for patients needing cervical preparation before a dilation and evacuation (D&E) procedure. Participants should require the procedure, be willing to stay overnight in the hospital, and have no contraindications to using CRDB catheters or osmotic dilators.

Inclusion Criteria

Residents of the state of Connecticut

I speak English or Spanish.

I am pregnant with one baby, between 19 to 24 weeks along.

Exclusion Criteria

Placenta accreta spectrum

Spontaneous or induced fetal demise

Multiple pregnancy

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 using either a CRDB catheter or osmotic dilators overnight

1 day

1 visit (in-person)

Dilation and Evacuation (D&E)

The cervical dilating device is removed, and the D&E procedure is performed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the D&E procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cervical Ripening Double Balloon (CRDB) Catheter
• Osmotic Dilators

Trial Overview The study compares two methods of preparing the cervix for D&E: an FDA-cleared Cervical Ripening Double Balloon (CRDB) Catheter versus standard overnight osmotic dilators. The goal is to see if CRDB is superior for this purpose.

How Is the Trial Designed?

Group I: Cervical Ripening Double Balloon (CRDB) Catheter Experimental Treatment 1 Intervention

Group II: Osmotic Dilators Active Control 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Citations

1. 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.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/rfc2.54

Double‐balloon catheter for induction of labour: Rates ... In this study, rates of vaginal birth were high (91%), and maternal infection (2.4%) and haemorrhage (3.5%) were low; however, these outcomes ...

3. europeanjournalofmidwifery.eu europeanjournalofmidwifery.eu/A-snapshot-of-women-s-and-clinicians-perceptions-of-the-double-balloon-catheter-for,146689,0,2.html

A snapshot of women's and clinicians' perceptions ... The majority of midwives and doctors agreed that on most occasions the double balloon catheter was effective as a cervical ripening device.

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

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 ...

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

Cervical Ripening and Induction of Labor Combining a balloon catheter with misoprostol is a common practice and has been shown to decrease time to delivery in a small study.

6. obgproject.com obgproject.com/2018/01/25/outpatient-balloon-catheters-labor-induction-assessment-potential-risks/

Outpatient Balloon Catheters for Labor Induction Risk of adverse events is very low for balloon catheter cervical ripening; The authors focused on low-risk but also included high-risk women ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211517304451

Review article Risk of maternal, fetal and neonatal ... This review shows that labour induction with a balloon catheter is a safe intervention, with intrapartum maternal infection being the only reasonable risk ...

8. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1111/aogs.14626

Double‐vs single‐balloon catheter for induction of labor ... Single-balloon catheter is at least comparable to double-balloon catheter in terms of vaginal birth rate and maternal and perinatal safety outcomes.

9. ajog.org ajog.org/article/S0002-9378(23)01298-X/fulltext

470 Double-balloon cervical ripening in women with ... Cervical ripening with a double-balloon catheter appears to be safe in the setting of ruptured membranes. For women with a scarred uterus, PROM, and an ...