Clinical trial NCT03140488: Oxytocin Dosage to Decrease Induction Duration
Official title: High Dose vs. Low Dose Oxytocin for Labor Induction in Obese Women: a Randomized Controlled Trial - the OPS (Obese Pitocin Study) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Labor, Induced
Oxytocin
Keywords: Induction of labor
Pitocin
BMI
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy ≥ 37 weeks gestation
* Patient presented for induction of labor who is determined to be a candidate for oxytocin
* Cephalic presentation
* Reassuring fetal health assessment (no abnormal findings in fetal assessment, see below)
* Meeting one of the following BMI category:

Obese group: BMI ≥30 at \<20 weeks of pregnancy, or BMI ≥35 at a term gestation of pregnancy Lean group: BMI ≤25 at \<20 weeks of pregnancy, or BMI ≤28 at a term gestation of pregnancy

Exclusion Criteria:

* Non-reassuring fetal assessment at the time of recruitment
* Previous cervical ripening agents (cytotec, cervidil, cervical Foley Balloon)
* \<18 years of age
* Prisoners
* Any patients contraindicated for vaginal delivery
* Multiple gestations
* History of previous cesarean delivery
* Patients with history of significant cardiac disease
* Fetal demise
* Estimated fetal weight greater than 4500 grams in diabetic and 5000 grams in non-diabetic mother
* Ruptured membranes
* Spontaneous labor (latent or active phase)
* Augmentation of labor (latent or active phase)

Primary outcomes:
measure: Length of Time to Delivery
timeFrame: Start of induction to Delivery
Secondary outcomes:
measure: Maximum Oxytocin Infusion Rate
timeFrame: Start of induction to Delivery
measure: Number of Participants With Terbutaline Use
timeFrame: Start of induction to Delivery
measure: Rate of Cesarean Delivery
timeFrame: Start of induction to Delivery
measure: Rate of Cesarean Delivery for Labor Arrest
timeFrame: Start of induction to Delivery
measure: Maternal Blood Loss
timeFrame: At delivery
measure: Number of Neonates With Apgar Score <7
timeFrame: 5 minutes after birth
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center Tucson
state: Arizona
Study officials:
affiliation: University of Arizona
name: Meghan Hill, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wei RM, Bounthavong M, Hill MG. High- vs low-dose oxytocin in lean and obese women: a double-blinded randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100627. doi: 10.1016/j.ajogmf.2022.100627. Epub 2022 Mar 28.