Labor Protocol Study
The goal of this study is to see if there is a better way to induce labor.
- Vaginal Delivery
- Induced; Birth
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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 Type
- Observational Model
- Time Perspective
|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.||
- NCT ID
- Montefiore Medical Center
Study ContactPeter Bernstein, MD
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.