Primary outcomeCount of participants· At time of delivery
Number of Participants Delivered by Cesarean
| Group | Value (Participants) |
|---|---|
| High Dose Oxytocin Regimen | 73 |
| Low Dose Oxytocin Regimen | 72 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataComparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
NCTNCT02487797 (opens ClinicalTrials.gov in a new tab)Other idSTU00201148
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 1,003 participants (actual)
- Sponsor
- Northwestern University · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 28 Sept 2015
- Primary completion
- 1 Sept 2020
- Completion
- 28 Sept 2020
- First posted
- 1 Jul 2015 (estimated)
- Last update posted
- 11 Feb 2022
- Conditions
- Dystocia
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2015201620172018201920202021
- Ph 4
Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
NCT0248779728 Sept 2015 to 28 Sept 2020
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
- Sodium Chloride 0.9%Other
Arms2
Experimental
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.
Active comparator
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants Delivered by Cesarean
Time frame · At time of delivery
Registry description
Number of participants delivered by cesarean section
Secondary outcomes(9)
Labor Augmentation Duration
Time frame · Number of hours from randomization to delivery
Registry description
Time from randomization to delivery
Number of Participants With Postpartum Hemorrhage
Time frame · From date of delivery to date of hospital discharge, an expected average of 3 days
Registry description
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
Time frame · From time of labor admission to time of delivery, an expected average of 24 to 48 hours
Registry description
Fever greater than 100.4 Fahrenheit in the intrapartum period with the initiation of a therapeutic antibiotic regimen in the intrapartum period
Number of Participants With Postpartum Endometritis
Time frame · From time of delivery to time of hospital discharge, an expected average of 3 days
Registry description
Fever greater than 100.4 Fahrenheit in the postpartum period with the initiation of a therapeutic antibiotic regimen in the postpartum period
Number of Participants Whose Offspring Experiences a Perinatal Death
Time frame · Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn)
Registry description
Perinatal death includes intrapartum stillbirth and neonatal death
Number of Participants With Umbilical Cord Acidemia
Time frame · At time of delivery
Registry description
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
Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life
Time frame · Delivery through 5 minutes of life
Registry description
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.
Admission to Neonatal Intensive Care Unit
Time frame · Delivery to 28 days of life
Registry description
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
Time frame · Delivery to 28 days of life
Registry description
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 results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Number of hours from randomization to delivery
Labor Augmentation Duration
| Group | Value (hours) | Spread |
|---|---|---|
| High Dose Oxytocin Regimen | 9.1 | 5.6 |
| Low Dose Oxytocin Regimen | 10.5 | 7.0 |
Secondary outcomeCount of participants· From date of delivery to date of hospital discharge, an expected average of 3 days
Number of Participants With Postpartum Hemorrhage
| Group | Value (Participants) |
|---|---|
| High Dose Oxytocin Regimen | 29 |
| Low Dose Oxytocin Regimen | 23 |
Secondary outcomeCount of participants· From time of labor admission to time of delivery, an expected average of 24 to 48 hours
Number of Participants With Intrapartum Chorioamnionitis
| Group | Value (Participants) |
|---|---|
| High Dose Oxytocin Regimen | 52 |
| Low Dose Oxytocin Regimen | 78 |
Secondary outcomeCount of participants· From time of delivery to time of hospital discharge, an expected average of 3 days
Number of Participants With Postpartum Endometritis
| Group | Value (Participants) |
|---|---|
| High Dose Oxytocin Regimen | 3 |
| Low Dose Oxytocin Regimen | 5 |
Secondary outcomeCount of participants· Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn)
Number of Participants Whose Offspring Experiences a Perinatal Death
| Group | Value (Participants) |
|---|---|
| High Dose Oxytocin Regimen | 0 |
| Low Dose Oxytocin Regimen | 0 |
Secondary outcomeCount of participants· At time of delivery
Number of Participants With Umbilical Cord Acidemia
| Group | Value (Participants) |
|---|---|
| High Dose Oxytocin Regimen | 14 |
| Low Dose Oxytocin Regimen | 27 |
Secondary outcomeCount of participants· Delivery through 5 minutes of life
Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life
| Group | Value (Participants) |
|---|---|
| High Dose Oxytocin Regimen | 3 |
| Low Dose Oxytocin Regimen | 4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| High Dose Oxytocin RegimenThe 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% | 0 / 502 | 0 / 502 | 0 / 502 |
| Low Dose Oxytocin RegimenThe 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 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
More studies
2 studies on this page
Indexing hint: Randomized controlled trial · 2023
Maximum Dose Rate of Intrapartum Oxytocin Infusion and Associated Obstetric and Perinatal Outcomes.
Son et al. 2023Obstetrics and gynecologycited by 3
PMID 36649339DOI 10.1097/aog.0000000000005058PUB-36649339
Rights unknown
Indexing hint: Randomized controlled trial · 2021
High-Dose Compared With Standard-Dose Oxytocin Regimens to Augment Labor in Nulliparous Women: A Randomized Controlled Trial.
Son et al. 2021Obstetrics and gynecologycited by 25
PMID 33957657DOI 10.1097/aog.0000000000004399PUB-33957657
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 45 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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