A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity (HILIO-PILOT)

  • STATUS
    Not Recruiting
  • participants needed
    20
  • sponsor
    Ohio State University
Updated on 3 December 2022

Summary

Pregnant patients with obesity are more likely to undergo induction of labor and have a higher risk of failed induction compared to patients with normal weight. The association between maternal obesity and labor dysfunction leading to cesarean delivery is poorly understood. Oxytocin is the mostly common medication used in induction of labor, yet optimal dosing of this medication is unknown. Studies have suggested that patients with obesity may be less responsive to oxytocin. This trial will compare a high and low dose oxytocin dosing regimen for the induction of labor in women with obesity.

Description

This study is a pragmatic single center randomized, double blinded controlled trial. Nulliparous women with a pre-pregnancy body mass index (BMI) ≥30 kg/m2 undergoing induction of labor at ≥37 weeks' gestation will be eligible for enrollment. Women will be randomly allocated to receive oxytocin using either a high-dose or low-dose regimen. Patients, providers, and research staff will be blinded to the dosing regimen. All other aspects of obstetric management will be at the discretion of the patient's clinical care team.

Postpartum maternal, neonatal, and delivery outcomes will be collected. Postpartum data through hospital discharge will be collected from the medical record. Information about complications following hospital discharge through 6 weeks after delivery will be collected during a research follow-up telephone call performed 6-8 weeks following delivery.

Details
Condition Pregnant Patients With Obesity
Treatment High-dose oxytocin, Low-dose oxytocin
Clinical Study IdentifierNCT05289869
SponsorOhio State University
Last Modified on3 December 2022

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