Purpose

The goal of this study is to see if there is a better way to induce labor.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Singleton pregnancy
  2. Cephalic presentation
  3. Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
  4. Age 18 and over

Exclusion Criteria

  1. Preterm (less than 36 weeks 6 days) at initiation of induction of labor
  2. Non-cephalic presentation
  3. Major fetal anomalies or intrauterine fetal death
  4. Bishop score more than 6 at initiation of induction of labor
  5. Any contraindication to any agents in the induction protocol (i.e. prior cesarean delivery or myomectomy, three or more contractions per ten minute period averaged over 30 minutes at the initiation of induction of labor, low lying placenta).
  6. Any contraindication to vaginal delivery
  7. Latex allergic

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Pregnant women We are including only women who are age 18 or over, who have a single baby (not twins), with the baby's head down, and are between 36 weeks 6 days and 42 weeks 0 days of pregnancy.
  • Drug: Cytotec
    Misoprostol 25mcg vaginal
    Other names:
    • misoprostol
  • Drug: oxytocin
    Oxytocin 10 IU/ml Solution for infusion
    Other names:
    • Pitocin
  • Device: Cervical Foley Balloon
    Cervical Foley will be inflated to 80cc

Recruiting Locations

Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine
Bronx, New York 10463
Contact:
Peter Bernstein, MD, MPH
718-904-2767
pbernste@montefiore.org

More Details

NCT ID
NCT04004845
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Peter Bernstein, MD
(718) 904-2767
pbernste@montefiore.org

Detailed Description

This is quasi-experimental prospective cohort study with historical control to examine the efficacy of a new labor induction bundle. The prospective cohort will consist of all eligible nulliparous and multiparous patients admitted for induction; the historical control group will consist of all eligible nulliparous and multiparous patients admitted for induction between August 2019 and February 2020. Patients who are part of the prospective cohort who do not consent to the labor bundle due to personal or physician preferences will be included in secondary analyses as a contemporary control group, however the sample size of this group will not be determined in advance.

Objective: To assess if implementation of an evidence-based labor induction bundle will increase the rate of vaginal delivery within 24 hours.

Hypothesis: Implementation of a labor induction bundle would result in a 30% increase in the rate of vaginal delivery within 24 hours.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.