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

Labor Long Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782816
• Other study ID #: 22-0240
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2023
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: Amanda Wang, MD
• Phone: 409-772-2891
• Email: ammwang[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Long

Intervention

Drug:
• Oxytocin
Low dose oxytocin
• Oxytocin
High dose oxytocin

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

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