Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Conditions
Keywords
nulliparous, labor induction, cervical ripening, misoprostol
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.
Interventions
COMBINATION_PRODUCTSequential 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_PRODUCTInpatient 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.
Sponsors
Ochsner Health System
Medicem International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants that complete vaginal delivery within 24 hours of hospital admission | Admission to 24 hours |
Countries
United States
Contacts
CONTACTFrank Williams, MD
CONTACTKen Bode
Outcome results
None listed