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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05782816
Other study ID # 22-0240
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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