Labor Long
Conditions
Keywords
induction of labor, augmentation of labor, oxytocin, pitocin, high dose, mode of delivery
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.
Interventions
Low dose oxytocin
High dose oxytocin
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Delivery | Through delivery, on average 24 hours | Induction to delivery time interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Primary Cesarean Delivery | Through delivery, on average 24 hours | Number of participants with primary cesarean delivery. |
| Maximum Dose of Oxytocin Infusion | Through delivery, on average 24 hours | The highest oxytocin infusion rate administered to a participant during the study period. |
| Rate of Uterine Tachysystole | 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. |
| Number of Participants With Postpartum Hemorrhage | From delivery through the postpartum period (average duration approximately 24 hours) | — |
| Rate of Placental Abruption | Through delivery, on average 24 hours | The number of participants with placental abruption. |
| Mode of Delivery | Through delivery, on average 24 hours | Vaginal or cesarean delivery |
| Rate of Maternal Infection (Endometritis, Chorioamnionitis) | Through delivery, on average 24 hours | The number of participants with maternal maternal infections (endometritis, choriomnionitis) |
| Rate of Serious Maternal Morbidity and Mortality | Through delivery, on average 24 hours | The number of participants with uterine rupture, admission to ICU, and septicemia or mortality. |
| 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) | Through delivery, on average 24 hours | Number of participants with umbilical artery acidemia (base excess \<12). |
| Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea | From delivery (average duration approximately 24 hours) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 84 |
| 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 | 85 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Low Dose Oxytocin | High Dose Oxytocin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 85 Participants | 169 Participants |
| Age, Continuous | 24.0 years | 23.8 years | 23.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants | 59 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 26 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 84 Participants | 85 Participants | 169 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 85 |
| other Total, other adverse events | 0 / 84 | 0 / 85 |
| serious Total, serious adverse events | 0 / 84 | 0 / 85 |
Outcome results
Primary
Time to Delivery
Induction to delivery time interval
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose Oxytocin | Time to Delivery | 1041.8 minutes | Standard Deviation 537.5 |
| High Dose Oxytocin | Time to Delivery | 971.1 minutes | Standard Deviation 519 |
Secondary
Maximum Dose of Oxytocin Infusion
The highest oxytocin infusion rate administered to a participant during the study period.
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose Oxytocin | Maximum Dose of Oxytocin Infusion | 11.8 mU/min |
| High Dose Oxytocin | Maximum Dose of Oxytocin Infusion | 15.6 mU/min |
Secondary
Mode of Delivery
Vaginal or cesarean delivery
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low Dose Oxytocin | Mode of Delivery | vaginal delivery | 58 Participants |
| Low Dose Oxytocin | Mode of Delivery | cesarean delivery | 25 Participants |
| Low Dose Oxytocin | Mode of Delivery | operative vaginal delivery | 1 Participants |
| High Dose Oxytocin | Mode of Delivery | vaginal delivery | 52 Participants |
| High Dose Oxytocin | Mode of Delivery | cesarean delivery | 1 Participants |
| High Dose Oxytocin | Mode of Delivery | operative vaginal delivery | 32 Participants |
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
Time frame: From birth through 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low 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 |
| 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 | 10 Participants |
Secondary
Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea
Time frame: From delivery (average duration approximately 24 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea | 0 Participants |
| High Dose Oxytocin | Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea | 0 Participants |
Secondary
Number of Participants With Neonatal Sepsis (Confirmed With Cultures)
Time frame: From birth through 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Number of Participants With Neonatal Sepsis (Confirmed With Cultures) | 0 Participants |
| High Dose Oxytocin | Number of Participants With Neonatal Sepsis (Confirmed With Cultures) | 0 Participants |
Secondary
Number of Participants With Postpartum Hemorrhage
Time frame: From delivery through the postpartum period (average duration approximately 24 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Number of Participants With Postpartum Hemorrhage | 1 Participants |
| High Dose Oxytocin | Number of Participants With Postpartum Hemorrhage | 4 Participants |
Secondary
Rate of Maternal Infection (Endometritis, Chorioamnionitis)
The number of participants with maternal maternal infections (endometritis, choriomnionitis)
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Rate of Maternal Infection (Endometritis, Chorioamnionitis) | 29 Participants |
| High Dose Oxytocin | Rate of Maternal Infection (Endometritis, Chorioamnionitis) | 30 Participants |
Secondary
Rate of Placental Abruption
The number of participants with placental abruption.
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Rate of Placental Abruption | 0 Participants |
| High Dose Oxytocin | Rate of Placental Abruption | 0 Participants |
Secondary
Rate of Primary Cesarean Delivery
Number of participants with primary cesarean delivery.
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Rate of Primary Cesarean Delivery | 25 Participants |
| High Dose Oxytocin | Rate of Primary Cesarean Delivery | 1 Participants |
Secondary
Rate of Serious Maternal Morbidity and Mortality
The number of participants with uterine rupture, admission to ICU, and septicemia or mortality.
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Rate of Serious Maternal Morbidity and Mortality | 0 Participants |
| High Dose Oxytocin | Rate of Serious Maternal Morbidity and Mortality | 0 Participants |
Secondary
Rate of Umbilical Artery Acidemia (Base Excess <12)
Number of participants with umbilical artery acidemia (base excess \<12).
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Rate of Umbilical Artery Acidemia (Base Excess <12) | 0 Participants |
| High Dose Oxytocin | Rate of Umbilical Artery Acidemia (Base Excess <12) | 1 Participants |
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.
Time frame: Through delivery, on average 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Oxytocin | Rate of Uterine Tachysystole | 15 Participants |
| High Dose Oxytocin | Rate of Uterine Tachysystole | 22 Participants |