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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
Singleton pregnancy
Cephalic presentation
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are pregnant with only one baby.
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The baby is positioned head-down in the mother's uterus.

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.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,611 Previous Clinical Trials
11,470,439 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research have an age limitation for participants?

"Patients of legal age or older, up to 50 years old, are encouraged to participate in this investigation."

Answered by AI

Could I qualify to participate in this experiment?

"All eligible candidates must be between the ages 18 and 50, with a past history of induced childbirth. This medical study is looking to enrol 90 participants in total."

Answered by AI

How many individuals are currently involved in this medical experiment?

"Affirmative. As per information on clinicaltrials.gov, this trial is in the process of recruiting participants and has been since May 1st 2022. The study was last updated on July 19th 2022 and aims to enroll 90 individuals at one location."

Answered by AI

Are there any current opportunities for prospective participants to join this trial?

"As detailed on clinicaltrials.gov, this research effort is still looking for participants as of July 19th 2022. The trial was originally announced to the public on May 1st 2022."

Answered by AI
Recent research and studies
New England Journal of MedicineJournal
Labor Induction Versus Expectant Management in Low-risk Nulliparous Women
Grobman, William A., Madeline M. Rice, Uma M. Reddy, Alan T.N. Tita, Robert M. Silver, Gail Mallett, Kim Hill, et al.. 2018. “Labor Induction Versus Expectant Management in Low-risk Nulliparous Women”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1800566.
Obstetrics & GynecologyJournal
Outpatient Foley Catheter for Induction of Labor in Nulliparous Women
Ausbeck, Elizabeth B., Victoria C. Jauk, Yumo Xue, Pamela Files, Spencer G. Kuper, Akila Subramaniam, Brian M. Casey, Jeff M. Szychowski, Lorie M. Harper, and Alan T. Tita. 2020. “Outpatient Foley Catheter for Induction of Labor in Nulliparous Women”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000004041.
American Journal of Obstetrics and GynecologyJournal
A Randomized Controlled Trial of Dilapan-s Vs Foley Balloon for Preinduction Cervical Ripening (DILAFOL Trial)
Saad, Antonio F., Josephine Villarreal, Joe Eid, Nicholas Spencer, Viviana Ellis, Gary D. Hankins, and George R. Saade. 2019. “A Randomized Controlled Trial of Dilapan-s Vs Foley Balloon for Preinduction Cervical Ripening (DILAFOL Trial)”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2019.01.008.
Frontiers in Public HealthJournal
Out-of-hospital Cervical Ripening with a Synthetic Hygroscopic Cervical Dilator May Reduce Hospital Costs and Cesarean Sections in the United States—a Cost-consequence Analysis
Saunders, Sita J., Rhodri Saunders, Tess Wong, and Antonio F. Saad. 2021. “Out-of-hospital Cervical Ripening with a Synthetic Hygroscopic Cervical Dilator May Reduce Hospital Costs and Cesarean Sections in the United States—a Cost-consequence Analysis”. Frontiers in Public Health. Frontiers Media SA. doi:10.3389/fpubh.2021.689115.
~27 spots leftby Apr 2025
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