Not yet recruiting NCT07717502
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sequential Cervical Ripening, Inpatient Combined Cervical Ripening.
- Who it may be relevant to
- Registry conditions: Nulliparous Women Who Scheduled for Labor Induction, Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 oxy - 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.
Primary outcome measures
- vaginal delivery within 24 hours of hospital admission [Time frame: Admission to 24 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Ochsner Baptist — New Orleans
Identifiers
NCT: NCT07717502 · 2025.432