Trial Outcomes & Findings for Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor (NCT NCT05782816)

NCT ID: NCT05782816

Last Updated: 2026-01-09

Results Overview

Induction to delivery time interval

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 170 participants
• Primary outcome timeframe: Through delivery, on average 24 hours
• Results posted on: 2026-01-09

Participant Flow

Participant milestones

Measure	Low Dose Oxytocin 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin 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. Oxytocin: High dose oxytocin
Overall Study STARTED	85	85
Overall Study COMPLETED	84	85
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Low Dose Oxytocin 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin 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. Oxytocin: High dose oxytocin
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin	Total n=169 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=8 Participants	85 Participants n=7 Participants	169 Participants n=15 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Age, Continuous	24.0 years n=8 Participants	23.8 years n=7 Participants	23.9 years n=15 Participants
Sex: Female, Male Female	84 Participants n=8 Participants	85 Participants n=7 Participants	169 Participants n=15 Participants
Sex: Female, Male Male	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	62 Participants n=8 Participants	59 Participants n=7 Participants	121 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=8 Participants	26 Participants n=7 Participants	48 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants

PRIMARY outcome

Timeframe: Through delivery, on average 24 hours

Induction to delivery time interval

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Time to Delivery	1041.8 minutes Standard Deviation 537.5	971.1 minutes Standard Deviation 519.0

SECONDARY outcome

Timeframe: Through delivery, on average 24 hours

Vaginal or cesarean delivery

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Mode of Delivery vaginal delivery	58 Participants	52 Participants
Mode of Delivery cesarean delivery	25 Participants	1 Participants
Mode of Delivery operative vaginal delivery	1 Participants	32 Participants

SECONDARY outcome

Timeframe: Through delivery, on average 24 hours

Number of participants with primary cesarean delivery.

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Rate of Primary Cesarean Delivery	25 Participants	1 Participants

SECONDARY outcome

Timeframe: Through delivery, on average 24 hours

The highest oxytocin infusion rate administered to a participant during the study period.

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Maximum Dose of Oxytocin Infusion	11.8 mU/min	15.6 mU/min

SECONDARY outcome

Timeframe: Through delivery, on average 24 hours

The number of participants with and without fetal heart rate changes and the need for cessation or decrease in oxytocin dosage.

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Rate of Uterine Tachysystole	15 Participants	22 Participants

SECONDARY outcome

Timeframe: From delivery through the postpartum period (average duration approximately 24 hours)

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Number of Participants With Postpartum Hemorrhage	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Through delivery, on average 24 hours

The number of participants with placental abruption.

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Rate of Placental Abruption	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From delivery (average duration approximately 24 hours)

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through delivery, on average 24 hours

The number of participants with maternal maternal infections (endometritis, choriomnionitis)

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Rate of Maternal Infection (Endometritis, Chorioamnionitis)	29 Participants	30 Participants

SECONDARY outcome

Timeframe: Through delivery, on average 24 hours

The number of participants with uterine rupture, admission to ICU, and septicemia or mortality.

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Rate of Serious Maternal Morbidity and Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From birth through 24 hours

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
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 Participants	10 Participants

SECONDARY outcome

Timeframe: From birth through 24 hours

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Number of Participants With Neonatal Sepsis (Confirmed With Cultures)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through delivery, on average 24 hours

Number of participants with umbilical artery acidemia (base excess <12).

Outcome measures

Measure	Low Dose Oxytocin n=84 Participants 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. Oxytocin: Low dose oxytocin	High Dose Oxytocin n=85 Participants 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. Oxytocin: High dose oxytocin
Rate of Umbilical Artery Acidemia (Base Excess <12)	0 Participants	1 Participants

Adverse Events

Low Dose Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Dose Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Wang, MD

University of Texas Medical Branch

Phone: 4097728666

Email: amanda.mei.wang@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place