Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS) | NCT07717502

NCT07717502

Overview

NCT ID: NCT07717502
Lead Sponsor: Ochsner Health SystemOTHER
Official Title: Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Brief Summary: 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.
Conditions: Nulliparous Women Who Scheduled for Labor Induction
Pregnancy
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Dec 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Nulliparous patients with singleton pregnancies with vertex lie at term receiving prenatal care that are eligible for outpatient cervical ripening will be eligible

Exclusion Criteria:

age less than 18,

suspected major fetal anomalies (including suspected or proven chromosome anomalies, congenital cardiac disease expected to require neonatal intervention, and multiple anomalies suggestive of a complex syndrome),

fetal growth restriction

oligohydramnios

prior full thickness

uterine scar

placenta previa,

low-lying placenta,

premature rupture of amniotic membranes,

cervical dilation > 2 cm

modified Bishop score > 4

residence greater than 60 minutes from the hospital

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 260Estimated
Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Frank Williams, MDContact
frank.williams2@ochsner.org205-994-4820

Similar Studies

Participant Group/Arms

Outpatient Sequential Cervical RipeningExperimental

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.

Combination Product: Sequential Cervical Ripening

Inpatient Combined Cervical RipeningActive Comparator

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.

Combination Product: Inpatient Combined Cervical Ripening