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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT05782816 (opens ClinicalTrials.gov in a new tab)Other id22-0240
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
170 participants (actual)
Sponsor
The University of Texas Medical Branch, Galveston · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
17 Apr 2023
Primary completion
31 Dec 2024
Completion
24 Jun 2025
First posted
24 Mar 2023
Last update posted
9 Jan 2026
Conditions
Labor Long

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 4

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

    NCT05782816

    17 Apr 2023 to 24 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oxytocin (Low dose)Drug
  • Oxytocin (High dose)Drug

Arms2

  • Active comparator

    Low dose oxytocin

    The low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.

  • Active comparator

    High dose oxytocin

    The high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will 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. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Delivery

    Time frame · Through delivery, on average 24 hours

    Registry description

    Induction to delivery time interval

Secondary outcomes(12)

  1. Mode of Delivery

    Time frame · Through delivery, on average 24 hours

    Registry description

    Vaginal or cesarean delivery

  2. Rate of Primary Cesarean Delivery

    Time frame · Through delivery, on average 24 hours

    Registry description

    Number of participants with primary cesarean delivery.

  3. Maximum Dose of Oxytocin Infusion

    Time frame · Through delivery, on average 24 hours

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Through delivery, on average 24 hours

Time to Delivery

GroupValue (minutes)Spread
Low Dose Oxytocin1041.8537.5
High Dose Oxytocin971.1519.0
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Through delivery, on average 24 hours

Mode of Delivery

GroupValue (Participants)
Low Dose Oxytocin58
High Dose Oxytocin52
Secondary outcomeCount of participants· Through delivery, on average 24 hours

Rate of Primary Cesarean Delivery

GroupValue (Participants)
Low Dose Oxytocin25
High Dose Oxytocin1
Secondary outcomeNumber· Through delivery, on average 24 hours

Maximum Dose of Oxytocin Infusion

GroupValue (mU/min)
Low Dose Oxytocin11.8
High Dose Oxytocin15.6
Secondary outcomeCount of participants· Through delivery, on average 24 hours

Rate of Uterine Tachysystole

GroupValue (Participants)
Low Dose Oxytocin15
High Dose Oxytocin22
Secondary outcomeCount of participants· From delivery through the postpartum period (average duration approximately 24 hours)

Number of Participants With Postpartum Hemorrhage

GroupValue (Participants)
Low Dose Oxytocin1
High Dose Oxytocin4
Secondary outcomeCount of participants· Through delivery, on average 24 hours

Rate of Placental Abruption

GroupValue (Participants)
Low Dose Oxytocin0
High Dose Oxytocin0
Secondary outcomeCount of participants· From delivery (average duration approximately 24 hours)

Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea

GroupValue (Participants)
Low Dose Oxytocin0
High Dose Oxytocin0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Low Dose OxytocinThe low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions. Oxytocin: Low dose oxytocin0 / 840 / 840 / 84
High Dose OxytocinThe high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will 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. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions. Oxytocin: High dose oxytocin0 / 850 / 850 / 85

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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