Outpatient Cervical Preparation to Reduce Induction Duration in NTSV Women
Withdrawn before enrolling · Not applicable
Conditions studied: Cervical Ripening, Outpatient, Patient Satisfaction, Nulliparous, Length of Stay
In brief
This study is to compare 2 groups in nulliparous women undergoing cervical ripening for induction of labor. The study hypothesis is that outpatient cervical preparation with a foley catheter can reduce the induction of labor (IOL) time interval from admission to delivery by 50%. A 30 ml transcervical foley catheter is a safe mode of cervical preparation in the outpatient setting, as concluded in Diederen et al, Sciscinoe et al, and Kelly et al. Findings from studies on nulliparous, term, singleton vertex (NTSV) showed patients can be applied to a wide variety of maternity unit sizes as discussed by Main et al. No previous study has evaluated the effectiveness of outpatient cervical preparation in the NTSV population by PUBMED search. Further, no previous study has assessed patient satisfaction cervical preparation in the outpatient setting and no previous study has evaluated whether outpatient cervical preparation has an impact on the length of stay and cost of hospitalization. This study will explore these important questions with the goal of improving current practices in labor induction to be more patient-centered, pragmatic, and cost-effective.
Key facts
- Study ID
- NCT03934918
- Run by
- University of California, Davis
- People needed
- 0
- Starts
- 2020-12-01
- Expected to finish
- 2022-06-01
- Last updated by the study team
- 2021-04-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Nulliparous women >18 years of age
- Singleton live pregnancy
- Vertex presentation
- Scheduled induction of labor between 37 and 42 weeks gestation
- Bishop score <6
You may not qualify if…
- Regular painful contractions (> every 5 minutes)
- Oligohydramnios or anhydramnios
- Breech presentation
- Rupture of membranes
- Fetal heart tracing with minimal variability or significant decelerations with >50% contractions
- Prior vaginal or cesarean delivery
- Contraindication to vaginal delivery (including placenta previa, morbidly adherent placenta, active genital herpes)
- Known or suspected placental abruption
- Major fetal anomaly
- Poorly controlled hypertension (using 2 or more medications; newly diagnosed preeclampsia; preeclampsia with severe features; superimposed preeclampsia)
- Poorly controlled diabetes
Where it is running
- University of California Davis — Sacramento, California, United States
Full record on ClinicalTrials.gov
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