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Study was temporarily paused due to COVID19 and ultimately terminated at the discretion of the PI
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The goal of this study is to see if there is a better way to induce labor.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytotec | Drug | Misoprostol 25mcg vaginal |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Vaginal Deliveries | Percent vaginal delivery within 24 hours of initiation of labor induction | Within 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of vaginal delivery within 12 hours of initiating induction | Within 12 hours | |
| Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction | Within 12 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women with a single baby who are having their labor induced.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bernstein, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine | The Bronx | New York | 10463 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11641677 | Background | 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. | |
| 29614276 | Background | 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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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| oxytocin | Drug | Oxytocin 10 IU/ml Solution for infusion |
|
|
| Cervical Foley Balloon | Device | Cervical Foley will be inflated to 80cc |
|
| 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 | mean, median | Within 4 days |
| Incidence of spontaneous internal version to non-cephalic presentation | Within 4 days |
| Incidence of umbilical cord prolapse | Within 4 days |
| Incidence of postpartum hemorrhage | Within 7 days |
| 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 | 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 |
| 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 |
| 22959833 | Background | 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. |
| 23926074 | Background | 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;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4. |
| Background | Battarbee, A.N., Maternal and neonatal outcomes associated with early amniotomy in term nulliparous labor induction. Am J Obstet Gynecol, 2019. 220: p. 1. |
| 27824758 | Background | 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. doi: 10.1097/AOG.0000000000001778. |
| 29215519 | Background | 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. |
| 29607491 | Background | 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. |
| 27500341 | Background | 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. |
| 27741203 | Background | 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. |
| 30304425 | Background | 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. |
| 30319925 | Background | 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. |
| 24565430 | Background | 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. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |