Labor Protocol Study

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

Detailed Description
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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.

Official Title
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Effect of a Labor Induction Protocol on Vaginal Delivery Rate

Conditions
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Vaginal Delivery, Labor, Induced; Birth

Intervention / Treatment
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* Drug: Cytotec
* Drug: oxytocin
* Device: Cervical Foley Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Cephalic presentation Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor Age 18 and over Exclusion Criteria: Preterm (less than 36 weeks 6 days) at initiation of induction of labor Non-cephalic presentation Major fetal anomalies or intrauterine fetal death Bishop score more than 6 at initiation of induction of labor 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). Any contraindication to vaginal delivery Latex allergic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>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<br>* Misoprostol 25mcg vaginal<br>* Other names: misoprostol;Drug: oxytocin<br>* Oxytocin 10 IU/ml Solution for infusion<br>* Other names: Pitocin;Device: Cervical Foley Balloon<br>* Cervical Foley will be inflated to 80cc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Vaginal Deliveries | 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 |  | Within 12 hours | 
| Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction |  | Within 12 hours | 
| Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction |  | Within 24 hours | 
| Rate of vaginal delivery |  | Within 4 days | 
| Rate of cesarean delivery |  | Within 4 days | 
| Rate of operative vaginal delivery |  | Within 4 days | 
| For patients undergoing cesarean delivery, rate of each indication for cesarean delivery |  | Within 4 days | 
| Incidence of chorioamnionitis |  | Within 4 days | 
| Number of vaginal exams | mean, median | Within 4 days | 
| Incidence of spontaneous internal version to non-cephalic presentation |  | Within 4 days | 
| Incidence of umbilical cord prolapse |  | Within 4 days | 
| Incidence of postpartum hemorrhage |  | Within 7 days | 
| Incidence of transfusion of blood products |  | Within 7 days | 
| Incidence of Neonatal 5-minute APGAR score <7 |  | Within 4 days | 
| Incidence of Umbilical cord pH < 7, <7.1, <7.2 |  | Within 4 days | 
| Incidence of Neonatal NICU admission |  | Within 7 days | 
| Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate | 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 |  | Within 4 days | 
| Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc). |  | Within 7 days | 
| Number of attending physicians managing induction of labor |  | Within 4 days | 
| Number of attending-to-attending hand-off's |  | Within 4 days | 
| Number of resident-to-resident team hand-off's |  | Within 4 days |