Clinical trial NCT04004845: Labor Protocol Study
Official title: Effect of a Labor Induction Protocol on Vaginal Delivery Rate
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vaginal Delivery
Labor
Induced; Birth
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with a single baby who are having their labor induced.

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.

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

Primary outcomes:
measure: Percentage of Vaginal Deliveries
timeFrame: Within 24 hours
Secondary outcomes:
measure: Percent of vaginal delivery within 12 hours of initiating induction
timeFrame: Within 12 hours
measure: Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction
timeFrame: Within 12 hours
measure: Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction
timeFrame: Within 24 hours
measure: Rate of vaginal delivery
timeFrame: Within 4 days
measure: Rate of cesarean delivery
timeFrame: Within 4 days
measure: Rate of operative vaginal delivery
timeFrame: Within 4 days
measure: For patients undergoing cesarean delivery, rate of each indication for cesarean delivery
timeFrame: Within 4 days
measure: Incidence of chorioamnionitis
timeFrame: Within 4 days
measure: Number of vaginal exams
timeFrame: Within 4 days
measure: Incidence of spontaneous internal version to non-cephalic presentation
timeFrame: Within 4 days
measure: Incidence of umbilical cord prolapse
timeFrame: Within 4 days
measure: Incidence of postpartum hemorrhage
timeFrame: Within 7 days
measure: Incidence of transfusion of blood products
timeFrame: Within 7 days
measure: Incidence of Neonatal 5-minute APGAR score <7
timeFrame: Within 4 days
measure: Incidence of Umbilical cord pH < 7, <7.1, <7.2
timeFrame: Within 4 days
measure: Incidence of Neonatal NICU admission
timeFrame: Within 7 days
measure: Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate
timeFrame: During delivery hospitalization
measure: Incidence of shoulder dystocia
timeFrame: Within 4 days
measure: Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc).
timeFrame: Within 7 days
measure: Number of attending physicians managing induction of labor
timeFrame: Within 4 days
measure: Number of attending-to-attending hand-off's
timeFrame: Within 4 days
measure: Number of resident-to-resident team hand-off's
timeFrame: Within 4 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Peter Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: How HY, Leaseburge L, Khoury JC, Siddiqi TA, Spinnato JA, Sibai BM. A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor. Am J Obstet Gynecol. 2001 Oct;185(4):911-5. doi: 10.1067/mob.2001.117358.
citation: Pimentel VM, Arabkhazaeli M, Moon JY, Wang A, Kapedani A, Bernstein PS, Tropper PJ. Induction of labor using one dose vs multiple doses of misoprostol: a randomized controlled trial. Am J Obstet Gynecol. 2018 Jun;218(6):614.e1-614.e8. doi: 10.1016/j.ajog.2018.03.034. Epub 2018 Mar 31.
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citation: Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.
citation: Schoen CN, Saccone G, Backley S, Sandberg EM, Gu N, Delaney S, Berghella V. Increased single-balloon Foley catheter volume for induction of labor and time to delivery: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2018 Sep;97(9):1051-1060. doi: 10.1111/aogs.13353. Epub 2018 Apr 25.
citation: Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
citation: Yee LM, Sandoval G, Bailit J, Reddy UM, Wapner RJ, Varner MW, Caritis SN, Prasad M, Tita ATN, Saade G, Sorokin Y, Rouse DJ, Blackwell SC, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Maternal and Neonatal Outcomes With Early Compared With Delayed Pushing Among Nulliparous Women. Obstet Gynecol. 2016 Nov;128(5):1039-1047. doi: 10.1097/AOG.0000000000001683.
citation: Cahill AG, Srinivas SK, Tita ATN, Caughey AB, Richter HE, Gregory WT, Liu J, Woolfolk C, Weinstein DL, Mathur AM, Macones GA, Tuuli MG. Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery Among Nulliparous Women Receiving Neuraxial Analgesia: A Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1444-1454. doi: 10.1001/jama.2018.13986.
citation: Simpson LL, Rochelson B, Ananth CV, Bernstein PS, D'Alton M, Chazotte C, Lavery JA, Zielinski K; Safe Motherhood Initiative Severe Hypertension in Pregnancy Work Group. Safe Motherhood Initiative: Early Impact of Severe Hypertension in Pregnancy Bundle Implementation. AJP Rep. 2018 Oct;8(4):e212-e218. doi: 10.1055/s-0038-1673632. Epub 2018 Oct 11.
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