Labor Protocol Study

October 2, 2022 updated by: Peter S. Bernstein, Montefiore Medical Center

Effect of a Labor Induction Protocol on Vaginal Delivery Rate

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10463
        • Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with a single baby who are having their labor induced.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Vaginal Deliveries
Time Frame: Within 24 hours
Percent vaginal delivery within 24 hours of initiation of labor induction
Within 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of vaginal delivery within 12 hours of initiating induction
Time Frame: Within 12 hours
Within 12 hours
Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction
Time Frame: Within 12 hours
Within 12 hours
Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction
Time Frame: Within 24 hours
Within 24 hours
Rate of vaginal delivery
Time Frame: Within 4 days
Within 4 days
Rate of cesarean delivery
Time Frame: Within 4 days
Within 4 days
Rate of operative vaginal delivery
Time Frame: Within 4 days
Within 4 days
For patients undergoing cesarean delivery, rate of each indication for cesarean delivery
Time Frame: Within 4 days
Within 4 days
Incidence of chorioamnionitis
Time Frame: Within 4 days
Within 4 days
Number of vaginal exams
Time Frame: Within 4 days
mean, median
Within 4 days
Incidence of spontaneous internal version to non-cephalic presentation
Time Frame: Within 4 days
Within 4 days
Incidence of umbilical cord prolapse
Time Frame: Within 4 days
Within 4 days
Incidence of postpartum hemorrhage
Time Frame: Within 7 days
Within 7 days
Incidence of transfusion of blood products
Time Frame: Within 7 days
Within 7 days
Incidence of Neonatal 5-minute APGAR score <7
Time Frame: Within 4 days
Within 4 days
Incidence of Umbilical cord pH < 7, <7.1, <7.2
Time Frame: Within 4 days
Within 4 days
Incidence of Neonatal NICU admission
Time Frame: Within 7 days
Within 7 days
Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate
Time Frame: During delivery hospitalization
Will analyze mean, median. Scale 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. Minimum score 1, Maximum score 10. A score of 1 is considered a worse outcome (completely dissatisfied) and 10 is considered a better outcome (completely satisfied). A score of 5 is neutral.
During delivery hospitalization
Incidence of shoulder dystocia
Time Frame: Within 4 days
Within 4 days
Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc).
Time Frame: Within 7 days
Within 7 days
Number of attending physicians managing induction of labor
Time Frame: Within 4 days
Within 4 days
Number of attending-to-attending hand-off's
Time Frame: Within 4 days
Within 4 days
Number of resident-to-resident team hand-off's
Time Frame: Within 4 days
Within 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Peter Bernstein, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 2, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-9662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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