NCT07717502 · Ochsner Health System
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
(RAPID-DS)
What this study is about
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.
View original scientific description
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 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.
Primary outcome measures
Number of Participants that complete vaginal delivery within 24 hours of hospital admission
Time frame: Admission to 24 hours
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Orleans, Louisiana
Collaborators
Medicem International
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2026 · Source of record for eligibility and locations