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

Study Overview
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Brief Summary
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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.

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

Conditions
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Labor Long

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose oxytocin<br>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<br>* Low dose oxytocin<br>|
| Active Comparator: High dose oxytocin<br>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<br>* High dose oxytocin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to delivery | Induction to delivery time interval | through study completion, expected to be 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Vaginal or cesarean delivery | through study completion, expected to be 2 years | 
| 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 | with and without fetal heart rate changes, need for cessation or decrease in oxytocin dosage | through study completion, expected to be 2 years | 
| 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 | Maternal side effects | through study completion, expected to be 2 years | 
| Rate of maternal infection (endometritis, chorioamnionitis) | Maternal side effects | through study completion, expected to be 2 years | 
| Rate of serious maternal morbidity and mortality | uterine rupture, admission to ICU, septicemia | through study completion, expected to be 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction of labor, augmentation of labor, oxytocin, pitocin, high dose, mode of delivery