Labor Protocol Study

Montefiore Medical Center66 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Vaginal Delivery Labor Induced; Birth

Interventions

CytotecDRUG

Misoprostol 25mcg vaginal

oxytocinDRUG

Oxytocin 10 IU/ml Solution for infusion

Cervical Foley BalloonDEVICE

Cervical Foley will be inflated to 80cc

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine

The Bronx, New York, United States

Outcomes

Primary Outcomes

Percentage of Vaginal Deliveries

Percent vaginal delivery within 24 hours of initiation of labor induction

Time frame: Within 24 hours

Secondary Outcomes

Percent of vaginal delivery within 12 hours of initiating induction

Time frame: Within 12 hours

Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction

Time frame: Within 12 hours

Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction

Time frame: Within 24 hours

Rate of vaginal delivery

Time frame: Within 4 days

Rate of cesarean delivery

Time frame: Within 4 days

Rate of operative vaginal delivery

Time frame: Within 4 days

For patients undergoing cesarean delivery, rate of each indication for cesarean delivery

Time frame: Within 4 days

Incidence of chorioamnionitis

Time frame: Within 4 days

Number of vaginal exams

mean, median

Time frame: Within 4 days

Incidence of spontaneous internal version to non-cephalic presentation

Data from ClinicalTrials.gov

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