DystociaPhase 4NCT02487797
Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
A Phase 4 study testing Oxytocin and Sodium Chloride 0.9% in people with Dystocia, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dystocia
- What is being tested?
- Oxytocin and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,003 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2015to 28 Sep 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Randomized Double Blind Clinical Trial Comparing Oxytocin Low-dose and High-dose Regimens for Labor Augmentation
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Sodium Chloride 0.9%Other
Also called Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxytocin; Other: Sodium Chloride 0.9% |
| 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. Receives: Drug: Oxytocin; Other: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Delivered by Cesarean
Number of participants delivered by cesarean section
Measured: At time of delivery
Secondary outcomes (9)
Labor Augmentation Duration
Time from randomization to delivery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Delivery through 5 minutes of life
Admission to Neonatal Intensive Care Unit
Number of participants whose neonates are admitted to Neonatal Intensive Care Unit
Measured: 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
Measured: Delivery to 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start28 Sep 2015
- Primary completion1 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DystociaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moeun Son, Northwestern University
- Investigators
- Moeun Son, MD, MSCI, Principal investigator, Northwestern UniversityAlan Peaceman, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487797
- Sponsor's protocol ID
- STU00201148
- Status last verified
- Feb 2022
- First submitted
- 9 Jun 2015
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 36649339Son 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.
PubMed 33957657
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Clinical Trial Comparing Oxytocin Low-dose and High-dose Regimens for Labor Augmentation
- ClinicalTrials.gov ID
- NCT02487797
- Acronym / sponsor ID
- STU00201148
- Conditions
- Dystocia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 11 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose oxytocin regimen | Experimental | Drug: Oxytocin, Other: Sodium Chloride 0.9%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 | 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Pitocin | Drug | High dose oxytocin regimen, Low dose oxytocin regimen |
| Sodium Chloride 0.9%Also: Normal Saline | Other | High dose oxytocin regimen, Low dose oxytocin regimen |
Primary outcome
Number of Participants Delivered by Cesarean
Time frame: At time of delivery
Number of participants delivered by cesarean section
9 secondary outcomes
Labor Augmentation Duration
Time frame: Number of hours 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
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
Number of Participants With Postpartum Endometritis
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
Time frame: Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn)
Number of Participants With Umbilical Cord Acidemia
Time frame: At time of delivery
Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life
Time frame: Delivery through 5 minutes of life
Admission 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
Time frame: Delivery to 28 days of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36649339Son 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.
- Derived from this study: PubMed 33957657Son 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moeun Son, MD, MSCI principal investigator
Northwestern University
Alan Peaceman, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin and Sodium Chloride 0.9% in people with Dystocia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Delivered by Cesarean (time frame: At time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.