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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03140488
Other study ID # 1702231223
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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