Post Partum HemorrhagePhase 2NCT05488457
Oxytocin Pharmacokinetics and Pharmacodynamics
A Phase 2 study testing deuterated oxytocin (d5OT) in people with Post Partum Hemorrhage and Cesarean Section Complications, run by Stanford University at 2 sites in United States.
Trial summary
Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Post Partum Hemorrhage, Cesarean Section Complications, Blood Loss
- What is being tested?
- deuterated oxytocin (d5OT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Phase 2
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 years old
- intrauterine pregnancy
- term (>39 weeks gestation or 37-39 weeks gestation with fetal or maternal medical indication for delivery) pregnancy
- non-emergent (scheduled or unscheduled) cesarean delivery
Who cannot join
- allergy or contraindication to oxytocin
- inability to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Naida M Cole, MD, 773-702-6700, nmcole@bsd.uchicago.edu
Somayeh Mohammadi, 17738343274, mohammadis@bsd.uchicago.edu
- Not yet recruiting
Stanford University
Stanford, California, 94305
Brendan Carvalho, MD, (650) 723-6415
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Oxytocin in Cesarean Delivery
Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus.
After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship.
The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.
Read the detailed description
Parturients aged 18-50 with an intrauterine term pregnancy (37 weeks or greater) undergoing non-emergent cesarean delivery at the University of Chicago (UC) and Stanford University will be recruited.
Methods: All subjects will receive standard pre-, intra- and postoperative care for their cesarean delivery with additional study interventions.
Study subjects will have an additional intravenous (IV) catheter inserted for intra-operative study-related blood draws.
A single, 1 International Unit (IU) bolus of deuterated oxytocin (d5OT) will be given to the subject, followed by an infusion of standard protocol oxytocin immediately after placental delivery. IV samples will be drawn from the study IV at 0, 1, 2.5, 5, 10, 20, 30, 45, 60 minutes following administration of the study drug. The samples will be processed, batched and shipped to the central lab being used in this study. Uterine tone scores will be measured simultaneously with blood draws until accurate palpation is no longer possible. Uterine tone score is a 0 to 10 numeric rating scale with 0 to describe unsatisfactory or no uterine tone and 10 to describe perfect uterine tone.
- Being tested
- deuterated oxytocin (d5OT)
- Keywords
- Oxytocin, pharmacokinetics and Pharmacodynamics, Uterine Tone, Postpartum, Elective C-Section, Parturients
- Medical subject headings
- Postpartum Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deuterated oxytocin (d5OT)Drug
Also called Deuterium-labeled oxytocin
Subjects will receive a 1 IU bolus of deuterated oxytocin (d5OT) intraoperatively during their nonemergent cesarean delivery.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin PK/PD Arm | Experimental | Eligible subjects will receive a single, 1 IU bolus of deuterated oxytocin (d5OT) intra-operatively, followed by an infusion of standard therapeutic d0 oxytocin immediately after placental delivery. Receives: Drug: deuterated oxytocin (d5OT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline plasma concentrations of deuterated oxytocin
The plasma concentration of deuterium labelled oxytocin at baseline
Measured: Intraoperatively (prior to delivery)
Plasma concentrations of deuterated oxytocin at 1 minute
The plasma concentration of deuterium labelled oxytocin at 1 minute post-study drug
Measured: Intraoperatively (1 minute following study drug administration)
Plasma concentrations of deuterated oxytocin at 2.5 minutes
The plasma concentration of deuterium labelled oxytocin at 2.5 minutes post-study drug
Measured: Intraoperatively (2.5 minutes following study drug administration)
Plasma concentrations of deuterated oxytocin at 5 minutes
The plasma concentration of deuterium labelled oxytocin at 5 minutes post-study drug
Measured: Intraoperatively (5 minutes following study drug administration)
Plasma concentrations of deuterated oxytocin at 10 minutes
The plasma concentration of deuterium labelled oxytocin at 10 minutes post-study drug
Measured: Intraoperatively (10 minutes following study drug administration)
Plasma concentrations of deuterated oxytocin at 15 minutes
The plasma concentration of deuterium labelled oxytocin at 15 minutes post-study drug
Measured: Intraoperatively (15 minutes following study drug administration)
Plasma concentrations of deuterated oxytocin at 20 minutes
The plasma concentration of deuterium labelled oxytocin at 20 minutes post-study drug
Measured: Intraoperatively (20 minutes following study drug administration)
Plasma concentrations of deuterated oxytocin at 30 minutes
The plasma concentration of deuterium labelled oxytocin at 30 minutes post-study drug
Measured: Intraoperatively (30 minutes following study drug administration)
Plasma concentrations of deuterated oxytocin at 45 minutes
The plasma concentration of deuterium labelled oxytocin at 45 minutes post-study drug
Measured: Intraoperatively (45 minutes following study drug administration)
Plasma concentrations of deuterated oxytocin at 60 minutes
The plasma concentration of deuterium labelled oxytocin at 60 minutes post-study drug
Measured: Intraoperatively (60 minutes following study drug administration)
0-10 Uterine Tone Score
Uterine tone will be ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (at the time of study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (1 minute following study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (2.5 minutes following study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (5 minutes following study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (10 minutes following study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (15 minutes following study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (20 minutes following study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (30 minutes following study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (45 minutes following study drug administration)
0-10 Uterine Tone Score
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
Measured: Intraoperatively (60 minutes following study drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Stanford 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive a 1 IU bolus of deuterated oxytocin (d5OT) intraoperatively during their cesarean delivery.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naida Cole, Stanford University
- Investigators
- Naida M Cole, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488457
- Sponsor's protocol ID
- 76388
- Other IDs
- IRB24-0480
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Oxytocin in Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05488457
- Acronym / sponsor ID
- 76388
- Keywords
- Oxytocin, pharmacokinetics and Pharmacodynamics, Uterine Tone, Postpartum, Elective C-Section, Parturients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Aug 2022 (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.
Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus.
After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship.
The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.
Detailed description
Parturients aged 18-50 with an intrauterine term pregnancy (37 weeks or greater) undergoing non-emergent cesarean delivery at the University of Chicago (UC) and Stanford University will be recruited.
Methods: All subjects will receive standard pre-, intra- and postoperative care for their cesarean delivery with additional study interventions.
Study subjects will have an additional intravenous (IV) catheter inserted for intra-operative study-related blood draws.
A single, 1 International Unit (IU) bolus of deuterated oxytocin (d5OT) will be given to the subject, followed by an infusion of standard protocol oxytocin immediately after placental delivery. IV samples will be drawn from the study IV at 0, 1, 2.5, 5, 10, 20, 30, 45, 60 minutes following administration of the study drug. The samples will be processed, batched and shipped to the central lab being used in this study. Uterine tone scores will be measured simultaneously with blood draws until accurate palpation is no longer possible. Uterine tone score is a 0 to 10 numeric rating scale with 0 to describe unsatisfactory or no uterine tone and 10 to describe perfect uterine tone.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive a 1 IU bolus of deuterated oxytocin (d5OT) intraoperatively during their cesarean delivery.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin PK/PD Arm | Experimental | Drug: deuterated oxytocin (d5OT)Eligible subjects will receive a single, 1 IU bolus of deuterated oxytocin (d5OT) intra-operatively, followed by an infusion of standard therapeutic d0 oxytocin immediately after placental delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-50 years old
- intrauterine pregnancy
- term (>39 weeks gestation or 37-39 weeks gestation with fetal or maternal medical indication for delivery) pregnancy
- non-emergent (scheduled or unscheduled) cesarean delivery
Key exclusion criteria (2 listed)
- allergy or contraindication to oxytocin
- inability to provide informed consent
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 |
|---|---|---|
| deuterated oxytocin (d5OT)Also: Deuterium-labeled oxytocinSubjects will receive a 1 IU bolus of deuterated oxytocin (d5OT) intraoperatively during their nonemergent cesarean delivery. | Drug | Oxytocin PK/PD Arm |
Primary outcome
Baseline plasma concentrations of deuterated oxytocin
Time frame: Intraoperatively (prior to delivery)
The plasma concentration of deuterium labelled oxytocin at baseline
Plasma concentrations of deuterated oxytocin at 1 minute
Time frame: Intraoperatively (1 minute following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 1 minute post-study drug
Plasma concentrations of deuterated oxytocin at 2.5 minutes
Time frame: Intraoperatively (2.5 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 2.5 minutes post-study drug
Plasma concentrations of deuterated oxytocin at 5 minutes
Time frame: Intraoperatively (5 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 5 minutes post-study drug
Plasma concentrations of deuterated oxytocin at 10 minutes
Time frame: Intraoperatively (10 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 10 minutes post-study drug
Plasma concentrations of deuterated oxytocin at 15 minutes
Time frame: Intraoperatively (15 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 15 minutes post-study drug
Plasma concentrations of deuterated oxytocin at 20 minutes
Time frame: Intraoperatively (20 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 20 minutes post-study drug
Plasma concentrations of deuterated oxytocin at 30 minutes
Time frame: Intraoperatively (30 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 30 minutes post-study drug
Plasma concentrations of deuterated oxytocin at 45 minutes
Time frame: Intraoperatively (45 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 45 minutes post-study drug
Plasma concentrations of deuterated oxytocin at 60 minutes
Time frame: Intraoperatively (60 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 60 minutes post-study drug
0-10 Uterine Tone Score
Time frame: Intraoperatively (at the time of study drug administration)
Uterine tone will be ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (1 minute following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (2.5 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (5 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (10 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (15 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (20 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (30 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (45 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
0-10 Uterine Tone Score
Time frame: Intraoperatively (60 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
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 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Post Partum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
RecruitingObservational study
Hemoglobin Testing in Pregnant Patients
Post Partum Hemorrhage, Anemia of Pregnancy
Recruiting
Effect of Simulation-Based Postpartum Hemorrhage Training on Team Performance in Senior Anesthesiology Teams
Postpartum Hemorrhage, Simulation Based Medical Education
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.
Naida M Cole, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing deuterated oxytocin (d5OT) in people with Post Partum Hemorrhage and Cesarean Section Complications, run by Stanford University at 2 sites 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 4 inclusion and 2 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Naida M Cole, MD (773-702-6700, nmcole@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline plasma concentrations of deuterated oxytocin (time frame: Intraoperatively (prior to delivery)). The study lists 20 primary outcomes in all. 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 21 Aug 2026.