Dystocia
Conditions
Brief summary
Oxytocin is a medication that is often used to strengthen contractions to overcome delayed labor progress. The primary aim of this study is to determine whether receiving a higher dose of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal Apgar score \<5 at 5 minutes, and need for neonatal intensive care.
Detailed description
This randomized double blind clinical trial of consenting nulliparous women in spontaneous labor who require oxytocin for labor augmentation seeks to determine whether use of a high dose oxytocin regimen improves obstetric outcomes when compared with a low dose oxytocin regimen, in a manner that is safe for both mother and neonate. This project will include 1002 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 36 weeks gestation, have a singleton pregnancy, and have been diagnosed with spontaneous labor or spontaneous rupture of membranes. Women will be exposed to oxytocin for the indication of labor augmentation at the discretion of their obstetric provider. Women will be randomized with equal probability to intervention group using a fixed allocation procedure. To maintain a double blind design, the Prentice Women's Hospital pharmacy will carry out the randomization of oxytocin solutions according to the random assignment so that neither the women or their care providers nor the investigators will know the identity of the intervention assignment. The low-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate of 2 milliunits/minute that can be increased at increments of 2 milliunits/minute, as per the discretion of their obstetric provider. The high-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate of 6 milliunits/minute that can be increased at increments of 6 milliunits/minute, as per the discretion of their obstetric provider. Once the women are enrolled, randomized, and in receipt of their assigned interventions, further clinical management will be left to the discretion of each woman's obstetric provider. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review.
Interventions
DRUGOxytocin
OTHERSodium Chloride 0.9%
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Able to give informed written consent * Age 18-45 years * Nulliparous * Pregnant with a live singleton gestation that is equal to or greater than 36 weeks * Diagnosed with at least 6 regular uterine contractions in an observation period of no more than 60 minutes and at least one of the following: spontaneous rupture of membranes, OR cervix greater than or equal to 3 centimeters dilated OR cervix at least 80% effaced. * The participant's attending obstetric physician or midwife has determined that the participant needs administration of oxytocin infusion for labor augmentation. Labor augmentation will be defined as stimulation of uterine contractions when spontaneous contractions have failed to result in progressive cervical dilation of descent of fetus.
Exclusion criteria
* Women not meeting the above criteria * History of prior cesarean section or uterine surgery * Fetus in non-cephalic presentation * Participant is undergoing labor induction (i.e. cervical ripening) * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Delivered by Cesarean | At time of delivery | Number of participants delivered by cesarean section |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postpartum Hemorrhage | From date of delivery to date of hospital discharge, an expected average of 3 days | Estimated blood loss greater than 500 milliliters after a vaginal delivery or greater than 1000 milliliters after a cesarean delivery |
| Number of Participants With Intrapartum Chorioamnionitis | From time of labor admission to time of delivery, an expected average of 24 to 48 hours | Fever greater than 100.4 Fahrenheit in the intrapartum period with the initiation of a therapeutic antibiotic regimen in the intrapartum period |
| Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life | Delivery through 5 minutes of life | Number of participants with neonates with Apgar score of less than 3 at 5 minutes of life. This is using a Apgar scale which ranges from minimum total score of 0 and maximum total score of 10, with higher score representing a better outcome. |
| Number of Participants With Postpartum Endometritis | From time of delivery to time of hospital discharge, an expected average of 3 days | Fever greater than 100.4 Fahrenheit in the postpartum period with the initiation of a therapeutic antibiotic regimen in the postpartum period |
| Labor Augmentation Duration | Number of hours from randomization to delivery | Time from randomization to delivery |
| Number of Participants With Umbilical Cord Acidemia | At time of delivery | Umbilical cord arterial blood pH less than 7.0 or base deficit greater than 12 mmol/L; or cord venous blood pH less than 7.0 or base deficit greater than 12 mmol/L when umbilical artery values are not available |
| Admission to Neonatal Intensive Care Unit | Delivery to 28 days of life | Number of participants whose neonates are admitted to Neonatal Intensive Care Unit |
| Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality | Delivery to 28 days of life | Neonatal composite morbidity will be defined as occurrence of any of the following: perinatal death, severe, respiratory distress, major birth injury, encephalopathy, seizure, need for hypothermic treatment, or sepsis |
| Number of Participants Whose Offspring Experiences a Perinatal Death | Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn) | Perinatal death includes intrapartum stillbirth and neonatal death |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Dose Oxytocin Regimen The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9% | 502 |
| Low Dose Oxytocin Regimen The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9% | 501 |
| Total | 1,003 |
Baseline characteristics
| Characteristic | High Dose Oxytocin Regimen | Total | Low Dose Oxytocin Regimen |
|---|---|---|---|
| Age, Continuous | 31.5 years STANDARD_DEVIATION 4.4 | 31.6 years STANDARD_DEVIATION 4.4 | 31.7 years STANDARD_DEVIATION 4.3 |
| Amniotomy before trial entry | 110 Participants | 235 Participants | 125 Participants |
| Body mass index at trial entry | 28.8 kg/m^2 | 29.2 kg/m^2 | 29.9 kg/m^2 |
| Chronic hypertension | 6 Participants | 10 Participants | 4 Participants |
| Female fetal sex | 268 Participants | 507 Participants | 239 Participants |
| Gestational age at trial entry (weeks) | 39.1 weeks STANDARD_DEVIATION 0.8 | 39.1 weeks STANDARD_DEVIATION 0.7 | 39.1 weeks STANDARD_DEVIATION 0.7 |
| Gestational or pre-gestational diabetes | 12 Participants | 27 Participants | 15 Participants |
| Group B Streptococcus carrier | 95 Participants | 183 Participants | 88 Participants |
| Hypertensive disorders of pregnancy | 47 Participants | 110 Participants | 63 Participants |
| Indication for trial entry Labor with intact membranes | 236 Participants | 477 Participants | 241 Participants |
| Indication for trial entry Spontaneous rupture of membranes | 266 Participants | 526 Participants | 260 Participants |
| Insurance type Commercial | 435 Participants | 877 Participants | 442 Participants |
| Insurance type Government | 66 Participants | 125 Participants | 59 Participants |
| Insurance type Uninsured | 1 Participants | 1 Participants | 0 Participants |
| Married or living with a partner | 396 Participants | 805 Participants | 409 Participants |
| Neonatal birthweight | 3325 grams | 3335 grams | 3350 grams |
| Neuraxial analgesia before trial entry | 246 Participants | 493 Participants | 247 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 42 Participants | 89 Participants | 47 Participants |
| Race/Ethnicity, Customized Black | 36 Participants | 80 Participants | 44 Participants |
| Race/Ethnicity, Customized Hispanic or Latina | 27 Participants | 53 Participants | 26 Participants |
| Race/Ethnicity, Customized Other, unknown, or more than one race | 65 Participants | 107 Participants | 42 Participants |
| Race/Ethnicity, Customized White | 332 Participants | 674 Participants | 342 Participants |
| Receipt of magnesium sulfate infusion | 10 Participants | 23 Participants | 13 Participants |
| Sex: Female, Male Female | 502 Participants | 1003 Participants | 501 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 / 502 | 0 / 501 |
| other Total, other adverse events | 0 / 502 | 0 / 501 |
| serious Total, serious adverse events | 0 / 502 | 0 / 501 |
Outcome results
Primary
Number of Participants Delivered by Cesarean
Number of participants delivered by cesarean section
Time frame: At time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Number of Participants Delivered by Cesarean | 73 Participants |
| Low Dose Oxytocin Regimen | Number of Participants Delivered by Cesarean | 72 Participants |
Secondary
Admission to Neonatal Intensive Care Unit
Number of participants whose neonates are admitted to Neonatal Intensive Care Unit
Time frame: Delivery to 28 days of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Admission to Neonatal Intensive Care Unit | 29 Participants |
| Low Dose Oxytocin Regimen | Admission to Neonatal Intensive Care Unit | 33 Participants |
Secondary
Labor Augmentation Duration
Time from randomization to delivery
Time frame: Number of hours from randomization to delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Oxytocin Regimen | Labor Augmentation Duration | 9.1 hours | Standard Deviation 5.6 |
| Low Dose Oxytocin Regimen | Labor Augmentation Duration | 10.5 hours | Standard Deviation 7 |
Secondary
Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life
Number of participants with neonates with Apgar score of less than 3 at 5 minutes of life. This is using a Apgar scale which ranges from minimum total score of 0 and maximum total score of 10, with higher score representing a better outcome.
Time frame: Delivery through 5 minutes of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life | 3 Participants |
| Low Dose Oxytocin Regimen | Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life | 4 Participants |
Secondary
Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality
Neonatal composite morbidity will be defined as occurrence of any of the following: perinatal death, severe, respiratory distress, major birth injury, encephalopathy, seizure, need for hypothermic treatment, or sepsis
Time frame: Delivery to 28 days of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality | 5 Participants |
| Low Dose Oxytocin Regimen | Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality | 7 Participants |
Secondary
Number of Participants Whose Offspring Experiences a Perinatal Death
Perinatal death includes intrapartum stillbirth and neonatal death
Time frame: Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Number of Participants Whose Offspring Experiences a Perinatal Death | 0 Participants |
| Low Dose Oxytocin Regimen | Number of Participants Whose Offspring Experiences a Perinatal Death | 0 Participants |
Secondary
Number of Participants With Intrapartum Chorioamnionitis
Fever greater than 100.4 Fahrenheit in the intrapartum period with the initiation of a therapeutic antibiotic regimen in the intrapartum period
Time frame: From time of labor admission to time of delivery, an expected average of 24 to 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Number of Participants With Intrapartum Chorioamnionitis | 52 Participants |
| Low Dose Oxytocin Regimen | Number of Participants With Intrapartum Chorioamnionitis | 78 Participants |
Secondary
Number of Participants With Postpartum Endometritis
Fever greater than 100.4 Fahrenheit in the postpartum period with the initiation of a therapeutic antibiotic regimen in the postpartum period
Time frame: From time of delivery to time of hospital discharge, an expected average of 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Number of Participants With Postpartum Endometritis | 3 Participants |
| Low Dose Oxytocin Regimen | Number of Participants With Postpartum Endometritis | 5 Participants |
Secondary
Number of Participants With Postpartum Hemorrhage
Estimated blood loss greater than 500 milliliters after a vaginal delivery or greater than 1000 milliliters after a cesarean delivery
Time frame: From date of delivery to date of hospital discharge, an expected average of 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Number of Participants With Postpartum Hemorrhage | 29 Participants |
| Low Dose Oxytocin Regimen | Number of Participants With Postpartum Hemorrhage | 23 Participants |
Secondary
Number of Participants With Umbilical Cord Acidemia
Umbilical cord arterial blood pH less than 7.0 or base deficit greater than 12 mmol/L; or cord venous blood pH less than 7.0 or base deficit greater than 12 mmol/L when umbilical artery values are not available
Time frame: At time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Oxytocin Regimen | Number of Participants With Umbilical Cord Acidemia | 14 Participants |
| Low Dose Oxytocin Regimen | Number of Participants With Umbilical Cord Acidemia | 27 Participants |