Recruiting

Sequential vs. Combined

Sponsor:

Ochsner Health System

Code:

NCT07717502

Conditions

Nulliparous Women Who Scheduled for Labor Induction

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sequential Cervical Ripening

Inpatient Combined Cervical Ripening

Study Details

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

Study ID

NCT07717502

Start date

Aug 18, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Number of Participants that complete vaginal delivery within 24 hours of hospital admission [ Time Frame: Admission to 24 hours ]

Central Contacts and Locations

Locations

Ochsner Baptist

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Principal Investigator:

Frank Williams, MD

More Information

Sponsor

Ochsner Health System

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • nulliparous
  • labor induction
  • cervical ripening
  • misoprostol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2026-08-24.