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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose oxytocin regimen | Experimental | 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. |
|
| Low dose oxytocin regimen | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Delivered by Cesarean | Number of participants delivered by cesarean section | At time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Labor Augmentation Duration | Time from randomization to delivery | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moeun Son, MD, MSCI | Northwestern University | Principal Investigator |
| Alan Peaceman, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36649339 | Derived | Son M, Roy A, Grobman WA, Miller ES, Dude A, Peaceman AM, Stetson B. Maximum Dose Rate of Intrapartum Oxytocin Infusion and Associated Obstetric and Perinatal Outcomes. Obstet Gynecol. 2023 Feb 1;141(2):379-386. doi: 10.1097/AOG.0000000000005058. Epub 2023 Jan 4. | |
| 33957657 | Derived | Son M, Roy A, Stetson BT, Grady NT, Vanecko MC, Bond N, Swanson K, Grobman WA, Miller ES, Peaceman AM. High-Dose Compared With Standard-Dose Oxytocin Regimens to Augment Labor in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):991-998. doi: 10.1097/AOG.0000000000004399. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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% |
| FG001 | 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% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Delivered by Cesarean | Number of participants delivered by cesarean section | Posted | Count of Participants | Participants | At time of delivery |
|
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.
Unanticipated adverse events will be defined as any event that meets the following conditions: the event is not a known or reasonably foreseeable risk associated with the study procedures (e.g. risks related to administration of oxytocin and confidential information specified in the informed consent), and the event, in the investigators' opinion, is or could be directly related to the subject's participation in this research protocol.
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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 | 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% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Moeun Son | Northwestern University, Yale University | 475-414-5328 | moeun.son@yale.edu |
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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 | May 4, 2020 | Sep 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004420 | Dystocia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Sodium Chloride 0.9% |
| Other |
|
|
| 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 | 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 | 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 | 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 | 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. | Delivery through 5 minutes of life |
| Admission to Neonatal Intensive Care Unit | Number of participants whose neonates are admitted to Neonatal Intensive Care Unit | 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 | Delivery to 28 days of life |
| BG001 | 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% |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Married or living with a partner | Count of Participants | Participants |
|
| Insurance type | Count of Participants | Participants |
|
| Body mass index at trial entry | Data missing for 6 participants | Median | Inter-Quartile Range | kg/m^2 |
|
| Gestational or pre-gestational diabetes | Count of Participants | Participants |
|
| Chronic hypertension | Count of Participants | Participants |
|
| Hypertensive disorders of pregnancy | Count of Participants | Participants |
|
| Group B Streptococcus carrier | Data missing for total of 25 participants | Count of Participants | Participants |
|
| Gestational age at trial entry (weeks) | Mean | Standard Deviation | weeks |
|
| Indication for trial entry | Count of Participants | Participants |
|
| Receipt of magnesium sulfate infusion | Count of Participants | Participants |
|
| Neuraxial analgesia before trial entry | Count of Participants | Participants |
|
| Amniotomy before trial entry | Count of Participants | Participants |
|
| Female fetal sex | Count of Participants | Participants |
|
| Neonatal birthweight | Median | Inter-Quartile Range | grams |
|
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% |
|
|
| Secondary | Labor Augmentation Duration | Time from randomization to delivery | Posted | Mean | Standard Deviation | hours | Number of hours from randomization to delivery |
|
|
|
| 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 | Posted | Count of Participants | Participants | From date of delivery to date of hospital discharge, an expected average of 3 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | From time of labor admission to time of delivery, an expected average of 24 to 48 hours |
|
|
|
| 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 | Posted | Count of Participants | Participants | From time of delivery to time of hospital discharge, an expected average of 3 days |
|
|
|
| Secondary | Number of Participants Whose Offspring Experiences a Perinatal Death | Perinatal death includes intrapartum stillbirth and neonatal death | Posted | Count of Participants | Participants | Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn) |
|
|
|
| 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 | Posted | Count of Participants | Participants | At time of delivery |
|
|
|
| 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. | Posted | Count of Participants | Participants | Delivery through 5 minutes of life |
|
|
|
| Secondary | Admission to Neonatal Intensive Care Unit | Number of participants whose neonates are admitted to Neonatal Intensive Care Unit | Posted | Count of Participants | Participants | Delivery to 28 days of life |
|
|
|
| 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 | Posted | Count of Participants | Participants | Delivery to 28 days of life |
|
|
|
| 0 |
| 502 |
| 0 |
| 502 |
| 0 |
| 502 |
| EG001 | 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% | 0 | 501 | 0 | 501 | 0 | 501 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |