NCT03140488

Oxytocin Dosage to Decrease Induction Duration

High Dose vs. Low Dose Oxytocin for Labor Induction in Obese Women: a Randomized Controlled Trial - the OPS (Obese Pitocin Study) Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial in which women are allocated either 'high dose' or 'low dose' oxytocin infusions for induction of labour. The randomization is stratified by maternal body mass index.

Detailed description

Obesity is considered a major public health concerns and increases the risk of many comorbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and postpartum. In particular, obese pregnant women have more difficulty going into labor, a longer labor course, and even with pharmacologic treatment, have a higher chance of requiring cesarean delivery. When pregnant women need help going into labor, they commonly receive a medication called Pitocin on the labor and delivery floor. Pitocin is the brand name and is a synthetic analog to the naturally produced oxytocin, a hormone secreted by mother when they naturally go into labor. This medication has been used widely around the world. There is emerging evidence that obese women need more oxytocin to go into labor compared to their lean cohorts. There are many studies to support the use of different oxytocin dosage protocols (both high and low dose infusion increments). Despite these evidences, a low dose oxytocin regimen is universally used in the United States, regardless of patient characteristics. This study is a double blinded randomized controlled trial. Both lean and obese cohorts will be recruited for the study. The investigators will randomly place both cohorts into the low or the high dose oxytocin regimen treatment group. The investigators, patients and providers will be blinded and will not know the specific assignments. The purpose of this study is to evaluate the effect of high dose oxytocin in the obese cohort. The hypothesis is that obese patient will have shorter time to delivery with the high dose oxytocin regimen without incurring any additional risks or adverse outcomes.

Conditions

• Obesity
• Labor, Induced
• Oxytocin

Interventions

Type	Name	Description
DRUG	Oxytocin	Patients will be randomized to low dose or high dose oxytocin for induction of labor.

Timeline

• Start date: 2017-06-05
• Primary completion: 2018-10-12
• Completion: 2019-09-05
• First posted: 2017-05-04
• Last updated: 2022-12-20
• Results posted: 2022-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study