Cervical Ripening for Labor Induction
(RAPID-DS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare the effectiveness of sequential versus combined multimodal cervical ripening strategies to achieve vaginal delivery within 24 hours among nulliparous patients with singleton, vertex pregnancies at term undergoing induction of labor.
Are You a Good Fit for This Trial?
This trial is for first-time pregnant women carrying one baby in head-down position at full term who need their labor induced. Women with certain medical conditions or complications may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Outpatient Sequential Cervical Ripening
Placement of Dilapan-S osmotic cervical dilators in the outpatient setting 12 to 24 hours prior to scheduled labor and delivery admission
Inpatient Combined Cervical Ripening
Placement of Dilapan-S and administration of misoprostol every 2 hours up to 8 doses until transition to oxytocin infusion
Follow-up
Participants are monitored for safety and effectiveness after delivery
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two ways to prepare the cervix for labor: using Dilapan-S and misoprostol one after another (sequential) versus both together (combined), to see which helps achieve vaginal delivery within 24 hours.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Those assigned to sequential cervical ripening will be scheduled with a trained physician for placement of Dilapan-STM osmotic cervical dilators in the outpatient setting at 12 to 24 hours prior to their scheduled labor and delivery admission. Upon admission to labor and delivery, sequential patients will have Dilapan-S removed during clinical vaginal exam and will receive misoprostol 25 mcg every two hours up to 8 doses until modified Bishop score is greater than 4, warranting transition to oxytocin infusion.
Those randomized to scheduled induction of labor in the inpatient setting will present as scheduled to labor unit, at which time they will undergo clinical assessment and will receive placement of Dilapan-S by a trained physician along with misoprostol 25 mcg every 2 hours up to 8 doses or until clinical exam demonstrates modified Bishop score greater than 4, warranting transition to oxytocin infusion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ochsner Health System
Lead Sponsor
Medicem International
Collaborator
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