Oxytocin Dosage to Decrease Induction Duration

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2019-09-05

Brief Summary

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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

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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

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Obesity Labor, Induced Oxytocin

Keywords

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Induction of labor Pitocin BMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 Comparison groups:

1. Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
2. Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
3. Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
4. Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This portion of the study will be carried out by the research pharmacy. Single (low dose) and triple (high dose) concentration of oxytocin will be premixed in the intravenous fluid bag in the pharmacy. Sequence generation for randomization will be created with 1:1 ratio in both the obese and lean group by the Department of Statistics. After the sequence is generated, ths list will be given to the research pharmacy. The premixed oxytocin medication will be sequentially labelled as "OPS drug, patient #1, 2, 3" etc. per the allocation. Allocation concealment will also be carried out by pharmacy as these bags will completely appear identical after they are labelled numerically. Once a patient is randomized, the pharmacy will send up the appropriate concentration of oxytocin already premixed in the intravenous fluid bag, labelled as "OPS drug, patient #". Lean group will be assigned at # 1-70 and obese group will be assigned at #71-140.

Study Groups

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Lean-Control

1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol

Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Group Type ACTIVE_COMPARATOR