Oxytocin Dosage to Decrease Induction Duration

Obesity Clinical Trial

— OPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140488
• Other study ID #: 1702231223
• Status: Completed
• Phase: Phase 4
• Start date: June 5, 2017
• Est. completion date: September 5, 2019

Study information

• Verified date: November 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 5, 2019
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Labor, Induced
• Obesity
• Oxytocin

Intervention

Drug:
• Oxytocin
Patients will be randomized to low dose or high dose oxytocin for induction of labor.

Locations

Country	Name	City	State
United States	Banner University Medical Center Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Time to Delivery	Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.	Start of induction to Delivery
Secondary	Maximum Oxytocin Infusion Rate	rate measured in milliunits/minute during induction of labour, no time limit applied.	Start of induction to Delivery
Secondary	Number of Participants With Terbutaline Use	If terbutaline was injected during labor to decrease number or strength of contraction	Start of induction to Delivery
Secondary	Rate of Cesarean Delivery	total number of patients who undergo cesarean delivery	Start of induction to Delivery
Secondary	Rate of Cesarean Delivery for Labor Arrest	Number of patients who undergo cesarean delivery due to labor arrest/ failed induction	Start of induction to Delivery
Secondary	Maternal Blood Loss	Blood loss in milliliters	At delivery
Secondary	Number of Neonates With Apgar Score <7	5 minute Apgar Score <7; *Apgar is an acronym for which each criterion is given a minimum of 0 and maximum of 2 points: Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), Respiration	5 minutes after birth