CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
High-dose oxytocin +1 moredrug
Likely dose
High-dose: 6 mU/min initial, increased by 6 mU/min every 30 minutes; Low-dose: 2 mU/min initial, increased by 2 mU/min every 30 minutesAI-extracted
Key inclusion· 9
  • Nulliparous (no prior vaginal deliveries)
  • Age > 18 years
  • Gestational age ≥37 weeks 0 days
  • Singleton pregnancy
Key exclusion· 11
  • Prior uterine surgery (cesarean, myomectomy, etc.)
  • Non-reassuring fetal status as indication for induction
  • Fetal demise
  • Major fetal congenital malformation or known chromosomal abnormality

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05289869
NCT05289869Phase 4Completed

The HILIO Trial: High vs. Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity- PILOT STUDY

Ohio State University·interventional·Posted Mar 22, 2022·Updated Nov 29, 2023

In Brief

A Phase 4 clinical trial evaluating High-dose oxytocin and Low-dose oxytocin for Pregnant Patients With Obesity. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMar 22, 2022
Enrollment StartApr 6, 2022
Primary CompletionSep 18, 2022
Study CompletionOct 28, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.3 years ago

Interventions

High-dose oxytocindrug

Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

Low-dose oxytocindrug

Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.