Labor Protocol Study

Montefiore Medicine Academic Health System

Status: Terminated

Conditions: Induced; Birth; Labor; Vaginal Delivery

Treatments: Drug: Cytotec; Drug: oxytocin; Device: Cervical Foley Balloon

Study type: Observational

Funder types: Other

Identifiers

NCT04004845

2018-9662

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

66 participants in 1 patient group

Pregnant women

Description:

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.

Treatment:

Device: Cervical Foley Balloon

Drug: oxytocin

Drug: Cytotec