A Study of Outpatient Cervical Preparation to Reduce Induction Duration in Pregnant Women

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Age: 18 years or older
Gender:
Female
Healthy Volunteers: No
Keywords: labor and delivery, labor induction
Type: Other study
Target:
100 Participants
Investigator:
Description
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.
This study requires

· If you decide to participate, you will be randomized to one of two groups. The group you are assigned to will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what group you get.

· You will be given an appointment date for either the start of your induction or outpatient cervical preparation with placement of a foley catheter in your cervix. This may be a same-day appointment depending on what time it is medically appropriate for your induction to begin.

Who can participate

Inclusion criteria:

  • Nulliparous women >18 years of age
  • Singleton live pregnancy
  • Vertex presentation
  • Scheduled induction of labor between 37 and 42 weeks gestation
  • Bishop score <6

Exclusion criteria:

  • 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will be in the study from the time of foley balloon insertion/labor induction until hospital discharge after giving birth.
Recruitment period
From March 6, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Courtney Overstreet
Research Topic
Conditions:
  • Cervical Ripening
  • Outpatient
  • Patient Satisfaction
  • Nulliparous
  • Length of Stay

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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