Phase 4
N=170
Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor
Labor Long
Bottom Line
View on ClinicalTrials.gov: NCT05782816 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Time to Delivery — 1041.8; 971.1 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Low dose) (Drug); Oxytocin (High dose) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Delivery |
1041.8; 971.1 | — |
| SECONDARY Mode of Delivery |
58; 52; 25; 1; 1; 32 | — |
| SECONDARY Rate of Primary Cesarean Delivery |
25; 1 | — |
| SECONDARY Maximum Dose of Oxytocin Infusion |
11.8; 15.6 | — |
| SECONDARY Rate of Uterine Tachysystole |
15; 22 | — |
| SECONDARY Number of Participants With Postpartum Hemorrhage |
1; 4 | — |
| SECONDARY Rate of Placental Abruption |
0; 0 | — |
| SECONDARY Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea |
0; 0 | — |
| SECONDARY Rate of Maternal Infection (Endometritis, Chorioamnionitis) |
29; 30 | — |
| SECONDARY Rate of Serious Maternal Morbidity and Mortality |
0; 0 | — |
| 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 |
7; 10 | — |
| SECONDARY Number of Participants With Neonatal Sepsis (Confirmed With Cultures) |
0; 0 | — |
| SECONDARY Rate of Umbilical Artery Acidemia (Base Excess <12) |
0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT05782816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.