Induction of Labor in Morbidly Obese Patients

Pregnancy Clinical Trial

Official title:

Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06199154
• Other study ID #: HP-00108436
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: Rosa Drummond, MD
• Phone: 4103285965
• Email: rosa.drummond[@]umm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: October 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Morbidly obese (BMI = 40 kg/m2) at admission for induction of labor

• Speaks English or Spanish

• Gestational age between 34 weeks and 0 days and 42 weeks and 6 days

• Age 18 years old or older

• Viable, single, cephalic fetus

• Intent to proceed with cervical ripening - cervical exam: dilation < 5 cm

• Contractions < 5 per 10 minutes

Exclusion Criteria:

• History of cesarean delivery

• Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)

• Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)

• Contraindications to labor (cardiac, neurosurgical, need for cesarean)

• Age < 18yo

• Fetal growth restriction with abnormal umbilical artery Doppler indices

• Cervical dilation >5 cm

• Contractions >5 per 10 minutes

• Significant vaginal bleeding with concern for placental abruption

• Non-reassuring fetal status or fetal heart rate decelerations

• Fetal demise or major fetal anomaly

• Inability to give consent

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Pregnancy

Intervention

Drug:
• Misoprostol
Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

References & Publications (9)

"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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of complete cervical dilation		Start of IOL until complete dilation
Secondary	Time interval from start of induction of labor (IOL) to complete cervical dilation		Start of IOL until complete dilation
Secondary	Achievement of 6 cm cervical dilation/active labor		Start of IOL until 6 cm dilation
Secondary	Time interval from start of IOL to 6 cm cervical dilation/active labor		Start of IOL until 6 cm dilation
Secondary	Time interval from start of IOL to vaginal delivery		Start of IOL until delivery
Secondary	Time interval from start of IOL to delivery		Start of IOL until delivery
Secondary	Incidence of vaginal deliveries		Start of IOL until delivery
Secondary	Incidence of cesarean deliveries		Start of IOL until delivery
Secondary	Indication for cesarean delivery	Maternal or Fetal	Start of IOL until delivery
Secondary	Cervical exam at time of cesarean delivery		Start of IOL until delivery
Secondary	Number of patients with tachysystole		Start of IOL until delivery
Secondary	Number of patients with tachysystole with non reassuring fetal heart rate (NRFHT)		Start of IOL until delivery
Secondary	Number of patients requiring terbutaline		Start of IOL until delivery
Secondary	Number of patients with chorioamnionitis		Start of IOL until delivery
Secondary	Number of patients with postpartum hemorrhage		Start of IOL until discharge, assessed up to 4 days
Secondary	Composite maternal morbidity (need for transfusion, sepsis, ICU admission, death)		Start of IOL until postpartum day 4
Secondary	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