Labor Protocol Study

Labor Clinical Trial

Official title:

Effect of a Labor Induction Protocol on Vaginal Delivery Rate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04004845
• Other study ID #: 2018-9662
• Status: Terminated
• Start date: March 30, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to see if there is a better way to induce labor.

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 information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Induced; Birth
• Labor
• Vaginal Delivery

Intervention

Drug:
• Cytotec
Misoprostol 25mcg vaginal
• oxytocin
Oxytocin 10 IU/ml Solution for infusion

Device:
• Cervical Foley Balloon
Cervical Foley will be inflated to 80cc

Locations

Country	Name	City	State
United States	Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine, Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026. — View 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. — View Citation

Battarbee, A.N., Maternal and neonatal outcomes associated with early amniotomy in term nulliparous labor induction. Am J Obstet Gynecol, 2019. 220: p. 1.

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. — View 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. — View Citation

Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. — View 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. Erratum in: Obstet Gynecol. 2018 Apr;131(4):745. — View Citation

Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24. — View 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. — View 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. — View 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. — View Citation

Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;(8):CD006794. doi: 10.1002/14651858.CD006794.pub4. Review. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Vaginal Deliveries	Percent vaginal delivery within 24 hours of initiation of labor induction	Within 24 hours
Secondary	Percent of vaginal delivery within 12 hours of initiating induction		Within 12 hours
Secondary	Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction		Within 12 hours
Secondary	Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction		Within 24 hours
Secondary	Rate of vaginal delivery		Within 4 days
Secondary	Rate of cesarean delivery		Within 4 days
Secondary	Rate of operative vaginal delivery		Within 4 days
Secondary	For patients undergoing cesarean delivery, rate of each indication for cesarean delivery		Within 4 days
Secondary	Incidence of chorioamnionitis		Within 4 days
Secondary	Number of vaginal exams	mean, median	Within 4 days
Secondary	Incidence of spontaneous internal version to non-cephalic presentation		Within 4 days
Secondary	Incidence of umbilical cord prolapse		Within 4 days
Secondary	Incidence of postpartum hemorrhage		Within 7 days
Secondary	Incidence of transfusion of blood products		Within 7 days
Secondary	Incidence of Neonatal 5-minute APGAR score <7		Within 4 days
Secondary	Incidence of Umbilical cord pH < 7, <7.1, <7.2		Within 4 days
Secondary	Incidence of Neonatal NICU admission		Within 7 days
Secondary	Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate	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.	During delivery hospitalization
Secondary	Incidence of shoulder dystocia		Within 4 days
Secondary	Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc).		Within 7 days
Secondary	Number of attending physicians managing induction of labor		Within 4 days
Secondary	Number of attending-to-attending hand-off's		Within 4 days
Secondary	Number of resident-to-resident team hand-off's		Within 4 days