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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.
The rate of IOL continues to increase, from about 10% in 1990 to 23% in 2018. Patients with BMI >40 are at increased risk for failed IOL and needing a CD. Studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery, but optimal dosing of misoprostol has not been studied as well. Increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity.
The investigators plan to conduct a randomized controlled double blinded trial. Patients who are scheduled for induction of labor after 34 weeks gestation, have a BMI >40, and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments. Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - 25 mcg vaginal misoprostol | Active Comparator | Participants will receive 25 mcg vaginal misoprostol every 4 hours. |
|
| Intervention - 50 mcg vaginal misoprostol | Experimental | Participants will receive 50 mcg vaginal misoprostol every 4 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of complete cervical dilation | Start of IOL until complete dilation |
| Measure | Description | Time Frame |
|---|---|---|
| Time interval from start of induction of labor (IOL) to complete cervical dilation | Start of IOL until complete dilation | |
| Achievement of 6 cm cervical dilation/active labor | Start of IOL until 6 cm dilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosa Drummond, MD | Contact | 4103285965 | rosa.drummond@umm.edu | |
| Krista Mehlhaff, DO | Contact | 4103285965 | KMehlhaff@som.umaryland.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Recruiting | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | ||
| 30648804 | 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. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Time interval from start of IOL to 6 cm cervical dilation/active labor | Start of IOL until 6 cm dilation |
| Time interval from start of IOL to vaginal delivery | Start of IOL until delivery |
| Time interval from start of IOL to delivery | Start of IOL until delivery |
| Incidence of vaginal deliveries | Start of IOL until delivery |
| Incidence of cesarean deliveries | Start of IOL until delivery |
| Indication for cesarean delivery | Maternal or Fetal | Start of IOL until delivery |
| Cervical exam at time of cesarean delivery | Start of IOL until delivery |
| Number of patients with tachysystole | Start of IOL until delivery |
| Number of patients with tachysystole with non reassuring fetal heart rate (NRFHT) | Start of IOL until delivery |
| Number of patients requiring terbutaline | Start of IOL until delivery |
| Number of patients with chorioamnionitis | Start of IOL until delivery |
| Number of patients with postpartum hemorrhage | Start of IOL until discharge, assessed up to 4 days |
| Composite maternal morbidity (need for transfusion, sepsis, ICU admission, death) | Start of IOL until postpartum day 4 |
| Composite neonatal morbidity (NICU admission, Apgar score =<7 at 5 minutes, sepsis, cord gas arterial pH <7.10 and/or base deficit < -12, active cooling protocol, death) | Start of IOL until discharge or day of life 30 |
| 30089070 | 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. |
| 27560557 | 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. |
| 24116732 | 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. |
| 19935035 | 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. |
| 36311296 | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |