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

NCT07717502 | Not Yet Recruiting

• 1 other identifier: 2025.432
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Keywords

nulliparous; labor induction; cervical ripening; misoprostol

Outcome Measures

Primary Outcomes (1)

• vaginal delivery within 24 hours of hospital admission

  Admission to 24 hours

Study Arms (2)

Outpatient Sequential Cervical Ripening

EXPERIMENTAL

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 Ripening

ACTIVE 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

Interventions

Sequential Cervical Ripening COMBINATION_PRODUCT

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.

Outpatient Sequential Cervical Ripening

Inpatient Combined Cervical Ripening COMBINATION_PRODUCT

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.

Inpatient Combined Cervical Ripening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead
• Medicem International: collaborator

Study Sites (1)

Ochsner Baptist

New Orleans, Louisiana, 70115, United States

Location

Central Study Contacts

Frank Williams, MD

CONTACT

205-994-4820; frank.williams2@ochsner.org

Ken Bode

CONTACT

504-842-1936; ken.bode@ochsner.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)