Cervical Ripening for Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether different methods of cervical ripening, a process that prepares the cervix for labor, can improve vaginal delivery rates. Participants will receive either a double balloon catheter, a double balloon catheter with misoprostol (a medication to induce labor), or standard care as determined by their provider. The trial is suitable for pregnant individuals at least 37 weeks along who plan an induced labor and can communicate in English, Spanish, or Haitian Creole. As a Phase 2/3 trial, this research measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to significant advancements in labor induction methods.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using a double balloon catheter is generally safe for starting labor. Studies indicate that 91% of women using this method achieve successful vaginal births. The risks of infection and heavy bleeding are low, at 2.4% and 3.5%, respectively. This method also results in fewer cases of excessive contractions, making it safer than some other methods.
When combined with misoprostol, a medication that softens the cervix, the double balloon catheter can reduce the likelihood of needing a cesarean section. This combination offers an effective balance between delivery times and safety, making it a strong choice for inducing labor. Both treatments have been well-studied and are generally well-tolerated, with few serious side effects reported.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for cervical ripening because they offer potentially improved methods for preparing the cervix for labor induction. The double balloon catheter alone provides a mechanical approach, which may reduce the need for medication and its associated side effects. When combined with misoprostol, a medication that softens and dilates the cervix, it could enhance effectiveness by leveraging both mechanical and pharmacological strategies. This combination might offer a more efficient and potentially faster alternative to the standard care options, which typically involve separate or less coordinated use of mechanical and drug-based methods.
What evidence suggests that this trial's treatments could be effective for cervical ripening?
Research has shown that the double balloon catheter is generally safe and effective for initiating labor. Many doctors and midwives find it effective for softening and opening the cervix, which is necessary for a vaginal birth. However, it has not proven to be clearly superior to other single methods used to induce labor. In this trial, one group of participants will receive cervical ripening with only a double balloon catheter.
Another group will receive the double balloon catheter combined with misoprostol. Studies have found that this combination can reduce the likelihood of needing a cesarean section, suggesting that using both the catheter and misoprostol may better support vaginal delivery.16789Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cervical ripening using standardized methods, including a double balloon catheter and/or misoprostol
Follow-up
Participants are monitored for maternal and fetal outcomes, including SVD rate and maternal morbidity
What Are the Treatments Tested in This Trial?
Interventions
- Double Balloon Catheter
- Double Balloon Catheter plus Misoprostol
- Usual-care Control Group
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Cervical ripening will occur using the method chosen by your provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Indiana University Health
Collaborator
Citations
1.
europeanjournalofmidwifery.eu
europeanjournalofmidwifery.eu/A-snapshot-of-women-s-and-clinicians-perceptions-of-the-double-balloon-catheter-for,146689,0,2.htmlA snapshot of women's and clinicians' perceptions ...
Doctors and midwives consistently believed that the double balloon catheter to be effective in ripening the cervix on most occasions, 83% (n=10) ...
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.
Induction of labour using cervical double-balloon (Cook ...
Our findings suggest that balloon catheters are generally safe and effective for induction of labor in both inpatient and outpatient settings, although this ...
4.
aci.health.nsw.gov.au
aci.health.nsw.gov.au/__data/assets/pdf_file/0008/986705/Evidence-brief-Cervical-ripening.pdfEvidence check: Cervical ripening
Double-vs single-balloon catheter for induction of labor: Systematic review and individual participant data meta-analysis. Acta Obstet ...
5.
obg.cuhk.edu.hk
obg.cuhk.edu.hk/wp-content/uploads/20210722_Double_Balloon_Device_for_6_Compared_With_12_Hours.22.pdfDouble-Balloon Device for 6 Compared With 12 Hours for ...
Cervical ripening with a double-balloon catheter removal at 6 hours, rather than 12 hours, results in a shortened time from insertion to ...
Efficacy and safety of double balloon catheter and ... - PMC
Double balloon catheter and dinoprostone seem to be equally effective, but double balloon catheter seem to be more safe than dinoprostone for induction of labor ...
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 ...
Duration of double balloon catheter for patients with prior ...
Planned removal at 6 hours compared to 12 hours may result in higher chances of successful vaginal delivery and possibly a shorter time to delivery.
9.
obgproject.com
obgproject.com/2017/06/11/double-balloon-catheter-prostaglandin-e2-cervical-ripening/Double-Balloon Catheter or Prostaglandin E2 for Cervical ...
The primary outcome measure was vaginal delivery rate within 24 hours and C-section risk. There was no statistical difference found between ...
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