NCT04004845

Labor Protocol Study

Effect of a Labor Induction Protocol on Vaginal Delivery Rate

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Vaginal Delivery
• Labor
• Induced; Birth

Interventions

Type	Name	Description
DRUG	Cytotec	Misoprostol 25mcg vaginal
DRUG	oxytocin	Oxytocin 10 IU/ml Solution for infusion
DEVICE	Cervical Foley Balloon	Cervical Foley will be inflated to 80cc

Timeline

• Start date: 2021-03-30
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2019-07-02
• Last updated: 2022-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study