Brief Summary
The goal of this study is to see if there is a better way to induce labor.
Brief Title
Labor Protocol Study
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Vaginal Delivery
Labor
Induced; Birth
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04004845
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9662
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Effect of a Labor Induction Protocol on Vaginal Delivery Rate
Primary Outcomes
Outcome Description
Percent vaginal delivery within 24 hours of initiation of labor induction
Outcome Measure
Percentage of Vaginal Deliveries
Outcome Time Frame
Within 24 hours
Secondary Outcomes
Outcome Time Frame
Within 12 hours
Outcome Measure
Percent of vaginal delivery within 12 hours of initiating induction
Outcome Time Frame
Within 12 hours
Outcome Measure
Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction
Outcome Time Frame
Within 24 hours
Outcome Measure
Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction
Outcome Time Frame
Within 4 days
Outcome Measure
Rate of vaginal delivery
Outcome Time Frame
Within 4 days
Outcome Measure
Rate of cesarean delivery
Outcome Time Frame
Within 4 days
Outcome Measure
Rate of operative vaginal delivery
Outcome Time Frame
Within 4 days
Outcome Measure
For patients undergoing cesarean delivery, rate of each indication for cesarean delivery
Outcome Time Frame
Within 4 days
Outcome Measure
Incidence of chorioamnionitis
Outcome Description
mean, median
Outcome Time Frame
Within 4 days
Outcome Measure
Number of vaginal exams
Outcome Time Frame
Within 4 days
Outcome Measure
Incidence of spontaneous internal version to non-cephalic presentation
Outcome Time Frame
Within 4 days
Outcome Measure
Incidence of umbilical cord prolapse
Outcome Time Frame
Within 7 days
Outcome Measure
Incidence of postpartum hemorrhage
Outcome Time Frame
Within 7 days
Outcome Measure
Incidence of transfusion of blood products
Outcome Time Frame
Within 4 days
Outcome Measure
Incidence of Neonatal 5-minute APGAR score <7
Outcome Time Frame
Within 4 days
Outcome Measure
Incidence of Umbilical cord pH < 7, <7.1, <7.2
Outcome Time Frame
Within 7 days
Outcome Measure
Incidence of Neonatal NICU admission
Outcome Description
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.
Outcome Time Frame
During delivery hospitalization
Outcome Measure
Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate
Outcome Time Frame
Within 4 days
Outcome Measure
Incidence of shoulder dystocia
Outcome Time Frame
Within 7 days
Outcome Measure
Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc).
Outcome Time Frame
Within 4 days
Outcome Measure
Number of attending physicians managing induction of labor
Outcome Time Frame
Within 4 days
Outcome Measure
Number of attending-to-attending hand-off's
Outcome Time Frame
Within 4 days
Outcome Measure
Number of resident-to-resident team hand-off's
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Pregnant women with a single baby who are having their labor induced.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Peter Bernstein
Investigator Email
pbernste@montefiore.org
Investigator Phone