Clinical trial NCT05782816: Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor
Official title: Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Labor Long
Keywords: induction of labor
augmentation of labor
oxytocin
pitocin
high dose
mode of delivery
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to delivery
timeFrame: through study completion, expected to be 2 years
Secondary outcomes:
measure: Mode of delivery
timeFrame: through study completion, expected to be 2 years
measure: Rate of primary cesarean delivery
timeFrame: through study completion, expected to be 2 years
measure: Maximum dose of oxytocin infusion
timeFrame: through study completion, expected to be 2 years
measure: Number of participants with uterine tachysystole
timeFrame: through study completion, expected to be 2 years
measure: Rate of postpartum hemorrhage
timeFrame: through study completion, expected to be 2 years
measure: Rate of placental abruption
timeFrame: through study completion, expected to be 2 years
measure: Number of participants with nausea/vomiting requiring antiemetics and diarrhea
timeFrame: through study completion, expected to be 2 years
measure: Rate of maternal infection (endometritis, chorioamnionitis)
timeFrame: through study completion, expected to be 2 years
measure: Rate of serious maternal morbidity and mortality
timeFrame: through study completion, expected to be 2 years
measure: 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
timeFrame: through study completion, expected to be 2 years
measure: Rate of neonatal infection
timeFrame: through study completion, expected to be 2 years
measure: Rate of neonates with 5 min APGAR score <7
timeFrame: through study completion, expected to be 2 years
measure: Rate of umbilical artery acidemia
timeFrame: through study completion, expected to be 2 years
measure: Rate of NICU admission
timeFrame: through study completion, expected to be 2 years
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Amanda Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: