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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:
Participants will be randomized to either low- or high-dose oxytocin groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose oxytocin | Active Comparator | 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. |
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| High dose oxytocin | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin (Low dose) | Drug | Low dose oxytocin |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Delivery | Induction to delivery time interval | Through delivery, on average 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mode of Delivery | Vaginal or cesarean delivery | Through delivery, on average 24 hours |
| Rate of Primary Cesarean Delivery | Number of participants with primary cesarean delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Wang, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Delivery | Induction to delivery time interval | Posted | Mean | Standard Deviation | minutes | Through delivery, on average 24 hours |
|
Through delivery, on average 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Wang, MD | University of Texas Medical Branch | 4097728666 | amanda.mei.wang@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2024 | Jul 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Oxytocin (High dose) | Drug | High dose oxytocin |
|
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| Through delivery, on average 24 hours |
| Maximum Dose of Oxytocin Infusion | The highest oxytocin infusion rate administered to a participant during the study period. | Through delivery, on average 24 hours |
| Rate of Uterine Tachysystole | The number of participants with and without fetal heart rate changes and the need for cessation or decrease in oxytocin dosage. | Through delivery, on average 24 hours |
| Number of Participants With Postpartum Hemorrhage | From delivery through the postpartum period (average duration approximately 24 hours) |
| Rate of Placental Abruption | The number of participants with placental abruption. | Through delivery, on average 24 hours |
| Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea | From delivery (average duration approximately 24 hours) |
| Rate of Maternal Infection (Endometritis, Chorioamnionitis) | The number of participants with maternal maternal infections (endometritis, choriomnionitis) | Through delivery, on average 24 hours |
| Rate of Serious Maternal Morbidity and Mortality | The number of participants with uterine rupture, admission to ICU, and septicemia or mortality. | Through delivery, on average 24 hours |
| 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 | From birth through 24 hours |
| Number of Participants With Neonatal Sepsis (Confirmed With Cultures) | From birth through 24 hours |
| Rate of Umbilical Artery Acidemia (Base Excess <12) | Number of participants with umbilical artery acidemia (base excess <12). | Through delivery, on average 24 hours |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Age measured in years. | Mean | Full Range | years |
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| Sex: Female, Male | Number of participants by sex at baseline. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Number of participants by ethnicity (Hispanic or Latino / Not Hispanic or Latino) as defined by NIH/OMB standards. | Count of Participants | Participants |
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| Secondary | Mode of Delivery | Vaginal or cesarean delivery | Posted | Count of Participants | Participants | Through delivery, on average 24 hours |
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| Secondary | Rate of Primary Cesarean Delivery | Number of participants with primary cesarean delivery. | Posted | Count of Participants | Participants | Through delivery, on average 24 hours |
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| Secondary | Maximum Dose of Oxytocin Infusion | The highest oxytocin infusion rate administered to a participant during the study period. | Posted | Number | mU/min | Through delivery, on average 24 hours |
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| Secondary | Rate of Uterine Tachysystole | The number of participants with and without fetal heart rate changes and the need for cessation or decrease in oxytocin dosage. | Posted | Count of Participants | Participants | Through delivery, on average 24 hours |
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| Secondary | Number of Participants With Postpartum Hemorrhage | Posted | Count of Participants | Participants | From delivery through the postpartum period (average duration approximately 24 hours) |
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| Secondary | Rate of Placental Abruption | The number of participants with placental abruption. | Posted | Count of Participants | Participants | Through delivery, on average 24 hours |
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| Secondary | Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea | Posted | Count of Participants | Participants | From delivery (average duration approximately 24 hours) |
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| Secondary | Rate of Maternal Infection (Endometritis, Chorioamnionitis) | The number of participants with maternal maternal infections (endometritis, choriomnionitis) | Posted | Count of Participants | Participants | Through delivery, on average 24 hours |
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| Secondary | Rate of Serious Maternal Morbidity and Mortality | The number of participants with uterine rupture, admission to ICU, and septicemia or mortality. | Posted | Count of Participants | Participants | Through delivery, on average 24 hours |
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| 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 | Posted | Count of Participants | Participants | From birth through 24 hours |
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| Secondary | Number of Participants With Neonatal Sepsis (Confirmed With Cultures) | Posted | Count of Participants | Participants | From birth through 24 hours |
|
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| Secondary | Rate of Umbilical Artery Acidemia (Base Excess <12) | Number of participants with umbilical artery acidemia (base excess <12). | Posted | Count of Participants | Participants | Through delivery, on average 24 hours |
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| 0 |
| 84 |
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| 84 |
| 0 |
| 84 |
| EG001 | 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 | 0 | 85 | 0 | 85 | 0 | 85 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| operative vaginal delivery |
|