Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial

NCT02639429 | Completed Phase 4 Results

• 1 other identifier: HSC-MS-15-0895
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.

Conditions

Obesity; Labor Induction; Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Need for Cesarean Delivery

  Induction to delivery

Secondary Outcomes (14)

• Indication for Cesarean Delivery

  Induction to delivery

• Induction-to-delivery Interval in Hours

  Induction to delivery

• Number of Participants With a Need for Oxytocin Augmentation

  Induction to delivery

• Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities

  Induction to delivery

• Number of Participants With Clinical Chorioamnionitis

  Induction to delivery

Study Arms (2)

Combined approach: Foley Balloon + Vaginal Misoprostol

EXPERIMENTAL

These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.

Device: Foley Balloon + Vaginal Misoprostol

Single approach: Vaginal Misoprostol only

ACTIVE COMPARATOR

These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score \> 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.

Drug: Vaginal Misoprostol

Interventions

Vaginal Misoprostol DRUG

Also known as: Cytotec

Single approach: Vaginal Misoprostol only

Foley Balloon + Vaginal Misoprostol DEVICE

Combined approach: Foley Balloon + Vaginal Misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous women aged 18 or above
• BMI ≥ 30 at the time of labor induction
• Singleton gestation
• Cephalic presentation (includes successful external cephalic version)
• Intact fetal membranes
• Unfavorable cervix (Bishop score of ≤ 6)
• Gestational age ≥ 32 weeks

You may not qualify if:

• Patient not candidate for IOL with misoprostol as deemed by the treating physician
• Multiple gestation
• Major fetal anomalies
• Fetal demise

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

• Viteri OA, Tabsh KK, Alrais MA, Salazar XC, Lopez JM, Fok RY, Chauhan SP, Sibai BM. Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial. Am J Perinatol. 2021 Aug;38(S 01):e123-e128. doi: 10.1055/s-0040-1708805. Epub 2020 Apr 16.

  PMID: 32299108 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Mesk Alrais, MD
• Organization: The University of Texas Health Science Center at Houston

Mesk.A.Alrais@uth.tmc.edu

(713) 566-5735

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Resident

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 24, 2015
• Study Start: January 1, 2016
• Primary Completion: June 24, 2018
• Study Completion: June 24, 2018
• Last Updated: August 26, 2019
• Results First Posted: August 26, 2019

Record last verified: 2019-08

Locations

US (1)