drugset / Trial / NCT06199154
Induction of Labor in Morbidly Obese Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.
Timeline
- Start
- 2024-07-15
- Primary completion
- 2026-05
- Completion
- 2026-10
Publications
- Background Hoyert, Donna L. "Maternal Mortality Rates in the United States, 2021." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 16 Mar. 2023, www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.htm.
- Background MarchofDimes. "Total Cesarean Deliveries by Maternal Race/Ethnicity: United States, 2019-2021 Average." March of Dimes | PeriStats, www.marchofdimes.org/peristats/data?reg=99&top=8&stop=356&lev=1&slev=1&obj=1. Accessed 14 Nov. 2023.
- Background "Adult Obesity Facts." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 17 May 2022, www.cdc.gov/obesity/data/adult.html.
- Background Ellis JA, Brown CM, Barger B, Carlson NS. Influence of Maternal Obesity on Labor Induction: A Systematic Review and Meta-Analysis. J Midwifery Womens Health. 2019 Jan;64(1):55-67. doi: 10.1111/jmwh.12935. Epub 2019 Jan 16.
- Background Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
- Background Beckwith L, Magner K, Kritzer S, Warshak CR. Prostaglandin versus mechanical dilation and the effect of maternal obesity on failure to achieve active labor: a cohort study. J Matern Fetal Neonatal Med. 2017 Jul;30(13):1621-1626. doi: 10.1080/14767058.2016.1220523. Epub 2016 Aug 25.
- Background O'Dwyer V, O'Kelly S, Monaghan B, Rowan A, Farah N, Turner MJ. Maternal obesity and induction of labor. Acta Obstet Gynecol Scand. 2013 Dec;92(12):1414-8. doi: 10.1111/aogs.12263.
- Background Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction. Obstet Gynecol. 2009 Dec;114(6):1315-1321. doi: 10.1097/AOG.0b013e3181bfb39f.
- Background Drummond R, Patel M, Myers M, Ritter A, Hurvitz JA, Goetzinger KR, Crimmins SD. Class III obesity is an independent risk factor for unsuccessful induction of labor. AJOG Glob Rep. 2022 Sep 23;2(4):100109. doi: 10.1016/j.xagr.2022.100109. eCollection 2022 Nov.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Misoprostol | Other / unclassified | 25 ug | Other |
| Subject | Misoprostol | Other / unclassified | 50 ug | Other |