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NCT Number: NCT07717502

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

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Key information

Conditions

Nulliparous Women Who Scheduled for Labor Induction Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Baptist

New Orleans, Louisiana, 70115, United States

Location contact

Frank Williams, MD

CONTACT

[email protected]

504-899-9311

Frank Williams, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

vaginal delivery within 24 hours of hospital admission

Time frame: Admission to 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Frank Williams, MD

CONTACT

[email protected]

205-994-4820

Ken Bode

CONTACT

[email protected]

504-842-1936

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Collaborators

Medicem International

Registry information

Acronym: RAPID-DS

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 21, 2026
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed