A Phase 4 interventional study of Oxytocin and Sodium Chloride 0.9% in Dystocia, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by Northwestern University · Phase 4, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 1,003 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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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.
Drug: Oxytocin · Other: Sodium Chloride 0.9%
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.
Drug: Oxytocin · Other: Sodium Chloride 0.9%
Also known as: Pitocin
Also known as: Normal Saline
Number of Participants Delivered by Cesarean
Number of participants delivered by cesarean section
Time frame: At time of delivery
Labor Augmentation Duration
Time from randomization to delivery
Time frame: Number of hours from randomization to delivery
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
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
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
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)
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
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
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
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
| Milestone | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Started | 502 | 501 |
| Completed | 502 | 501 |
| Not completed | 0 | 0 |
Number of participants delivered by cesarean section
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Number of Participants Delivered by Cesarean | 73 | 72 |
Time from randomization to delivery
| hours | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Labor Augmentation Duration | 9.1 ± 5.6 | 10.5 ± 7.0 |
Estimated blood loss greater than 500 milliliters after a vaginal delivery or greater than 1000 milliliters after a cesarean delivery
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Number of Participants With Postpartum Hemorrhage | 29 | 23 |
Fever greater than 100.4 Fahrenheit in the intrapartum period with the initiation of a therapeutic antibiotic regimen in the intrapartum period
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Number of Participants With Intrapartum Chorioamnionitis | 52 | 78 |
Fever greater than 100.4 Fahrenheit in the postpartum period with the initiation of a therapeutic antibiotic regimen in the postpartum period
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Number of Participants With Postpartum Endometritis | 3 | 5 |
Perinatal death includes intrapartum stillbirth and neonatal death
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Number of Participants Whose Offspring Experiences a Perinatal Death | 0 | 0 |
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
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Number of Participants With Umbilical Cord Acidemia | 14 | 27 |
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.
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life | 3 | 4 |
Number of participants whose neonates are admitted to Neonatal Intensive Care Unit
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Admission to Neonatal Intensive Care Unit | 29 | 33 |
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
| Participants | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen |
|---|---|---|
| Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality | 5 | 7 |
Collected over Maternal adverse events were monitored from study enrollment until delivery hospitalization discharge, typically up to 5 days. Neonatal outcomes were monitored from birth until birth hospitalization discharge or 28 days of life, whichever came first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Dose Oxytocin Regimen | 0/502 (0%) | 0/502 (0%) | 0/502 (0%) |
| Low Dose Oxytocin Regimen | 0/501 (0%) | 0/501 (0%) | 0/501 (0%) |
| Age, Continuous(years) | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen | Total |
|---|---|---|---|
| Mean | 31.5 ± 4.4 | 31.7 ± 4.3 | 31.6 ± 4.4 |
| Sex: Female, Male(Participants) | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen | Total |
|---|---|---|---|
| Female | 502 | 501 | 1003 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen | Total |
|---|---|---|---|
| White | 332 | 342 | 674 |
| Black | 36 | 44 | 80 |
| Hispanic or Latina | 27 | 26 | 53 |
| Asian or Pacific Islander | 42 | 47 | 89 |
| Other, unknown, or more than one race | 65 | 42 | 107 |
| Married or living with a partner(Participants) | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen | Total |
|---|---|---|---|
| Count of participants | 396 | 409 | 805 |
| Insurance type(Participants) | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen | Total |
|---|---|---|---|
| Commercial | 435 | 442 | 877 |
| Government | 66 | 59 | 125 |
| Uninsured | 1 | 0 | 1 |
| Body mass index at trial entry(kg/m^2) | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen | Total |
|---|---|---|---|
| Median | 28.8 (26.4 to 32.0) | 29.9 (26.9 to 32.8) | 29.2 (26.6 to 32.5) |
| Gestational or pre-gestational diabetes(Participants) | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen | Total |
|---|---|---|---|
| Count of participants | 12 | 15 | 27 |
| Chronic hypertension(Participants) | High Dose Oxytocin Regimen | Low Dose Oxytocin Regimen | Total |
|---|---|---|---|
| Count of participants | 6 | 4 | 10 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2015 to primary completion in Sep 2020, 59 months.
Results were first posted in Feb 2022, 1 year 5 months after primary completion.
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Studies of the drug tested here: Oxytocin