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Completed

NCT Number: NCT03140488

Oxytocin Dosage to Decrease Induction Duration

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Banner University Medical Center Tucson

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxytocin

Drug

Patients will be randomized to low dose or high dose oxytocin for induction of labor.

Other names: Pitocin, Syntocinon

Primary outcomes

  1. Length of Time to Delivery

    Time frame: Start of induction to Delivery

    Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.

Secondary outcomes

  1. Maximum Oxytocin Infusion Rate

    Time frame: Start of induction to Delivery

    rate measured in milliunits/minute during induction of labour, no time limit applied.

  2. Number of Participants With Terbutaline Use

    Time frame: Start of induction to Delivery

    If terbutaline was injected during labor to decrease number or strength of contraction

  3. Rate of Cesarean Delivery

    Time frame: Start of induction to Delivery

    total number of patients who undergo cesarean delivery

  4. Rate of Cesarean Delivery for Labor Arrest

    Time frame: Start of induction to Delivery

    Number of patients who undergo cesarean delivery due to labor arrest/ failed induction

  5. Maternal Blood Loss

    Time frame: At delivery

    Blood loss in milliliters

  6. Number of Neonates With Apgar Score <7

    Time frame: 5 minutes after birth

    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

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Acronym: OPS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 4, 2017
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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