Labor ComplicationROSSoLNCT04303702
The Role of Oxytocin in the Second Stage of Labor
A study testing Continue Oxytocin and Discontinue Oxytocin in people with Labor Complication, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complication
- What is being tested?
- Continue Oxytocin and Discontinue Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nulliparous pregnant women >/= 37 weeks gestation
- Singleton pregnancies
- Admission for induction of labor or spontaneous labor
Who cannot join
- Multiple gestations
- Multiparous patients
- Patients with major fetal anomalies
- Not on oxytocin at the time of complete cervical dilation
- Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation
- Maternal medical condition that prohibits prolonged second stage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
Nandini Raghuraman, MD MS, 918-691-7389, raghuramann@wudosis.wustl.edu
About this study
Official title: Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)
This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.
Read the detailed description
Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.
- Conditions
- Labor Complication
- Being tested
- Continue Oxytocin, Discontinue Oxytocin
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continue OxytocinDrug
The administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functions for intravenous administration of oxytocin that is milliunit-based and the same routine pumps will be used in this study. The study bag will be administered per current oxytocin protocol. Since patients will already be on oxytocin at time of randomization, their current bag of oxytocin will be continued by the primary provider at a rate of their discretion.
Discontinue OxytocinOther
Patients will have their oxytocin discontinued in the second stage of labor. The patient will receive routine maintenance IV fluids per the discretion of the provider.
| Study group | Role | What they receive |
|---|---|---|
| Discontinue Oxytocin | Other | Not described Receives: Other: Discontinue Oxytocin |
| Continue Oxytocin | Active comparator | Not described Receives: Drug: Continue Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Second stage duration
Time interval from complete cervical dilation to delivery of fetus
Measured: During admission for delivery
Secondary outcomes (7)
Rate of operative delivery
Rate of cesarean section and operative vaginal delivery including forcep or vacuum
Measured: During admision for delivery
Rate of Postpartum hemorrhage
Estimated blood loss >500 mL for vaginal delivery and >1000 mL for cesarean delivery
Measured: During admission for delivery
Estimated blood loss
Estimated blood loss at time of delivery (mL)
Measured: During admission for delivery
Rate of chorioamnionitis during the second stage of labor
Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor
Measured: During admission for delivery
Rate of endometritis
Postpartum endometritis as diagnosed by primary provider
Measured: During admission for delivery
Rate of severe perineal laceration
3rd or 4th degree perineal laceration
Measured: During admission for delivery
Rate of composite neonatal morbidity
1 or more of the following: death, birth injury, umbilical artery acidosis, respiratory distress, transient tachypnea, meconium aspiration with pulmonary hypertension, hypoxic-ischemic encephalopathy, hypoglycemia, hypothermia treatment, or suspected neonatal sepsis.
Measured: During admission for delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Jul 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Nandini Raghuraman, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303702
- Sponsor's protocol ID
- 201909112
- Acronym
- ROSSoL
- Status last verified
- Dec 2025
- First submitted
- 6 Mar 2020
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)
- ClinicalTrials.gov ID
- NCT04303702
- Acronym / sponsor ID
- ROSSoL / 201909112
- Conditions
- Labor Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.
Detailed description
Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.
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 |
|---|---|---|
| Discontinue Oxytocin | Other | Other: Discontinue Oxytocin |
| Continue Oxytocin | Active comparator | Drug: Continue Oxytocin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Nulliparous pregnant women >/= 37 weeks gestation
- Singleton pregnancies
- Admission for induction of labor or spontaneous labor
Key exclusion criteria (6 listed)
- Multiple gestations
- Multiparous patients
- Patients with major fetal anomalies
- Not on oxytocin at the time of complete cervical dilation
- Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation
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 |
|---|---|---|
| Continue OxytocinThe administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functions for intravenous administration of oxytocin that is milliunit-based and the same routine pumps will be used in this study. The study bag will be administered per current oxytocin protocol. Since patients will already be on oxytocin at time of randomization, their current bag of oxytocin will be continued by the primary provider at a rate of their discretion. | Drug | Continue Oxytocin |
| Discontinue OxytocinPatients will have their oxytocin discontinued in the second stage of labor. The patient will receive routine maintenance IV fluids per the discretion of the provider. | Other | Discontinue Oxytocin |
Primary outcome
Second stage duration
Time frame: During admission for delivery
Time interval from complete cervical dilation to delivery of fetus
7 secondary outcomes
Rate of operative delivery
Time frame: During admision for delivery
Rate of Postpartum hemorrhage
Time frame: During admission for delivery
Estimated blood loss
Time frame: During admission for delivery
Rate of chorioamnionitis during the second stage of labor
Time frame: During admission for delivery
Rate of endometritis
Time frame: During admission for delivery
Rate of severe perineal laceration
Time frame: During admission for delivery
Rate of composite neonatal morbidity
Time frame: During admission for delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continue Oxytocin and Discontinue Oxytocin in people with Labor Complication, run by Washington University School of Medicine 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nandini Raghuraman, MD MSCI (9186917389, nraghuraman@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Second stage duration (time frame: During admission for delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.