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

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05782816

Collaborator

(none)

170

Enrollment

Location

Arms

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Long	Drug: Oxytocin Drug: Oxytocin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Oxytocin Low dose oxytocin
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.	Drug: Oxytocin High dose oxytocin

Arm

Intervention/Treatment

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.

Drug: Oxytocin

Low dose oxytocin

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.

Drug: Oxytocin

High dose oxytocin

Outcome Measures

Primary Outcome Measures

Time to delivery [through study completion, expected to be 2 years]
Induction to delivery time interval

Secondary Outcome Measures

Mode of delivery [through study completion, expected to be 2 years]
Vaginal or cesarean delivery
Rate of primary cesarean delivery [through study completion, expected to be 2 years]
Maximum dose of oxytocin infusion [through study completion, expected to be 2 years]
Number of participants with uterine tachysystole [through study completion, expected to be 2 years]
with and without fetal heart rate changes, need for cessation or decrease in oxytocin dosage
Rate of postpartum hemorrhage [through study completion, expected to be 2 years]
Rate of placental abruption [through study completion, expected to be 2 years]
Number of participants with nausea/vomiting requiring antiemetics and diarrhea [through study completion, expected to be 2 years]
Maternal side effects
Rate of maternal infection (endometritis, chorioamnionitis) [through study completion, expected to be 2 years]
Maternal side effects
Rate of serious maternal morbidity and mortality [through study completion, expected to be 2 years]
uterine rupture, admission to ICU, septicemia
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 [through study completion, expected to be 2 years]
Rate of neonatal infection [through study completion, expected to be 2 years]
Rate of neonates with 5 min APGAR score <7 [through study completion, expected to be 2 years]
Rate of umbilical artery acidemia [through study completion, expected to be 2 years]
Rate of NICU admission [through study completion, expected to be 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Medical Branch	Galveston	Texas	United States	77555

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Medical Branch, Galveston

ClinicalTrials.gov Identifier:

NCT05782816

Other Study ID Numbers:

22-0240

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by The University of Texas Medical Branch, Galveston

induction of labor

augmentation of labor

Additional relevant MeSH terms:

Oxytocin

Study Results

No Results Posted as of Mar 24, 2023