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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Nulliparous Women Who Scheduled for Labor Induction
• Intervention / Treatment: Combination product: Sequential Cervical Ripening; Combination product: Inpatient Combined Cervical Ripening

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ken Bode; Phone Number: 504-842-1936; Email: ken.bode@ochsner.org
• Study Contact Backup: Name: Frank Williams, MD; Phone Number: 205-994-4820; Email: frank.williams2@ochsner.org

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Baptist
      • Contact: Frank Williams, MD; Phone Number: 504-899-9311; Email: frank.williams2@ochsner.org
      • Principal Investigator: Frank Williams, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient Sequential Cervical Ripening; 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; 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.
Active Comparator: Inpatient Combined Cervical Ripening; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
vaginal delivery within 24 hours of hospital admission	Admission to 24 hours

Collaborators and Investigators

• Sponsor: Ochsner Health System
• Collaborators: Medicem International

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: misoprostol; cervical ripening; labor induction; nulliparous
• Other Study ID Numbers: 2025.432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Findings will be disseminated via abstract submissions at national obstetrical meetings along with manuscripts targeting a high impact obstetrics journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No