Labor Protocol Study
- Conditions
- Induced; BirthVaginal DeliveryLabor
- Interventions
- Registration Number
- NCT04004845
- Lead Sponsor
- Montefiore Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 66
- Singleton pregnancy
- Cephalic presentation
- Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
- Age 18 and over
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant women Cytotec 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. Pregnant women Cervical Foley Balloon 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. Pregnant women oxytocin 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.
- Primary Outcome Measures
Name Time Method Percentage of Vaginal Deliveries Within 24 hours Percent vaginal delivery within 24 hours of initiation of labor induction
- Secondary Outcome Measures
Name Time Method Incidence of transfusion of blood products Within 7 days Incidence of Neonatal 5-minute APGAR score <7 Within 4 days 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 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 Within 4 days mean, median
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 Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction Within 24 hours 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 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.
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
Trial Locations
- Locations (1)
Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States