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Dilapan-S for Induced Birth

N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours
Awards & highlights

Study Summary

This trial is testing if Dilapan-S is as good as Cook balloon for outpatient cervical ripening, by seeing if it can increase Bishop score just as much.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Bishop Score
Secondary outcome measures
Cervical Ripening Success Score: No Failure, Failure
Composite Maternal Morbidity: Morbidity, no Morbidity
Composite Neonatal Morbidity: Morbidity, no Morbidity
+4 more

Trial Design

2Treatment groups
Active Control
Group I: Dilapan-SActive Control1 Intervention
After randomization, the patient will have Dilapan-S placed via sterile speculum exam with placement of 3-5 rods. The rods will remain in place until expelled or up to 24 hours or until the scheduled return to labor and delivery. At presentation to labor and delivery, the rods will be confirmed expelled or will be removed and a blinded examiner will complete a sterile cervical exam. At that point the primary health care providers will manage further labor per their standard practice.
Group II: Cook CatheterActive Control1 Intervention
After randomization, the patient will have the Cook catheter placed via sterile vaginal or speculum exam with the uterine component of the balloon inflated to maximum 60mL. The balloon will remain in place until expelled or up to 24 hours or until the scheduled return to labor and delivery. At presentation to labor and delivery, the Cook catheter will be confirmed expelled or will be removed and a blinded examiner will complete a sterile cervical exam. At that point the primary health care providers will manage further labor per their standard practice.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,622 Previous Clinical Trials
11,468,677 Total Patients Enrolled
~26 spots leftby Jun 2025
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