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NCT Number: NCT05782816

Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor

The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question[s] it aims to answer are:

* Does a high dose oxytocin infusion protocol affect length of induction to delivery interval? * Does a high dose oxytocin infusion protocol affect mode of delivery? * Does a high dose oxytocin infusion protocol affect maternal and neonatal outcomes?

Participants will be randomized to either low- or high-dose oxytocin groups:

* The low dose group will receive an infusion to start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. The maximum rate of infusion is 40 milli-units/min. * The high dose group will receive an infusion to start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min.

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Key information

Conditions

Labor Long

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged 18-50 years old
  • Singleton gestation
  • Nulliparous
  • Vertex presentation
  • Gestational age greater than or equal to 37 weeks
  • No prior uterine surgery
  • Presents for elective or medically indicated induction of labor
  • Need for augmentation of labor with oxytocin

Exclusion criteria

  • Previous cervical ripening using non-mechanical methods
  • Patient unable or unwilling to provide verbal consent
  • Contraindications to vaginal delivery
  • Fetal demise or life-limiting anomaly
  • Allergy to oxytocin
  • Non-reassuring fetal heart tracing prior to inclusion
  • Maternal pulmonary edema prior to inclusion
  • Fetal growth restriction

Treatment and study plan

Oxytocin (Low dose)

Drug

Low dose oxytocin

Other names: Pitocin, Syntocinon

Oxytocin (High dose)

Drug

High dose oxytocin

Other names: Pitocin, Syntocinon

Primary outcomes

  1. Time to Delivery

    Time frame: Through delivery, on average 24 hours

    Induction to delivery time interval

Secondary outcomes

  1. Mode of Delivery

    Time frame: Through delivery, on average 24 hours

    Vaginal or cesarean delivery

  2. Rate of Primary Cesarean Delivery

    Time frame: Through delivery, on average 24 hours

    Number of participants with primary cesarean delivery.

  3. Maximum Dose of Oxytocin Infusion

    Time frame: Through delivery, on average 24 hours

    The highest oxytocin infusion rate administered to a participant during the study period.

  4. Rate of Uterine Tachysystole

    Time frame: Through delivery, on average 24 hours

    The number of participants with and without fetal heart rate changes and the need for cessation or decrease in oxytocin dosage.

  5. Number of Participants With Postpartum Hemorrhage

    Time frame: From delivery through the postpartum period (average duration approximately 24 hours)

  6. Rate of Placental Abruption

    Time frame: Through delivery, on average 24 hours

    The number of participants with placental abruption.

  7. Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea

    Time frame: From delivery (average duration approximately 24 hours)

  8. Rate of Maternal Infection (Endometritis, Chorioamnionitis)

    Time frame: Through delivery, on average 24 hours

    The number of participants with maternal maternal infections (endometritis, choriomnionitis)

  9. Rate of Serious Maternal Morbidity and Mortality

    Time frame: Through delivery, on average 24 hours

    The number of participants with uterine rupture, admission to ICU, and septicemia or mortality.

  10. Number of Neonates With One or More of: Perinatal Death, Severe Respiratory Distress Requiring Ventilation, Neonatal Encephalopathy, Neonatal Seizure, Neonatal Sepsis, 5-minute APGAR Score <7, Umbilical Artery Acidemia, Neonatal ICU Admission

    Time frame: From birth through 24 hours

  11. Number of Participants With Neonatal Sepsis (Confirmed With Cultures)

    Time frame: From birth through 24 hours

  12. Rate of Umbilical Artery Acidemia (Base Excess <12)

    Time frame: Through delivery, on average 24 hours

    Number of participants with umbilical artery acidemia (base excess <12).

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor: A Randomized Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 24, 2023
Registry last updated
Jan 9, 2026

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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