Vaginal Delivery, Labor, Induced; Birth
Conditions
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.
Interventions
DRUGCytotec
Misoprostol 25mcg vaginal
DRUGoxytocin
Oxytocin 10 IU/ml Solution for infusion
DEVICECervical Foley Balloon
Cervical Foley will be inflated to 80cc
Sponsors
Montefiore Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Vaginal Deliveries | Within 24 hours | Percent vaginal delivery within 24 hours of initiation of labor induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | — |
| Percent of vaginal delivery within 12 hours of initiating induction | Within 12 hours | — |
| 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 | 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 | — |
| Incidence of postpartum hemorrhage | Within 7 days | — |
Countries
United States
Outcome results
None listed