Postpartum HemorrhagePhase 4INBOX-HRNCT07688512
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
A Phase 4 study testing Oxytocin Bolus or Oxytocin Infusion in people with Postpartum Hemorrhage and Uterine Atony, run by Stony Brook University.
Trial summary
The goal of this randomized, double-blind clinical trial is to learn if Oxytocin is most effective at achieving adequate uterine tone (important for preventing postpartum hemorrhage) when administered as a bolus or an infusion in patients at high-risk for postpartum hemorrhage in elective cesarean sections. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Uterine Atony, Uterine Atony With Hemorrhage
- What is being tested?
- Oxytocin Bolus or Oxytocin Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Feb 2029
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing elective cesarean section under spinal anesthesia or combined spinal anesthesia (CSE)
- Patients must be able to provide written informed consent in either English or Spanish
- Parturient classified as high risk for postpartum hemorrhage as defined by the adapted California Maternal Quality Care Obstetric Hemorrhage Risk Screen
Who cannot join
- Parturient in labor or ruptured membranes
- Patient does not possess the physical and mental capacity to provide informed consent
- Urgent or emergent cesarean sections
- Patients with a known major coagulopathy
- Patients with significant thrombocytopenia limiting neuraxial anesthesia (<70k)
- Patients on therapeutic anticoagulation at time of procedure
Show all 9Show fewer
- Patients on the placenta accreta spectrum
- Patients with severe cardiac disease contraindicating oxytocin
- Patients with an allergy to oxytocin
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section
The goal of this randomized, double-blind clinical trial is to learn if Oxytocin is most effective at achieving adequate uterine tone (important for preventing postpartum hemorrhage) when administered as a bolus or an infusion in patients at high-risk for postpartum hemorrhage in elective cesarean sections. The main questions that will be answered are:
- Is Oxytocin bolus more effective than Oxytocin infusion at achieving adequate uterine tone at 2 minutes after the baby is born and every minute thereafter?
- Does Oxytocin bolus cause less maternal side effects than Oxytocin infusion?
- Does Oxytocin bolus result in less blood loss than Oxytocin infusion in high risk for postpartum hemorrhage patients undergoing elective cesarean sections?
- Are patients more satisfied with their cesarean section when they receive Oxytocin bolus or Oxytocin infusion?
Read more
Researchers will compare the 2 methods of Oxytocin administration, bolus versus infusion, to see which method is more effective or if they are equally effective.
Participants will:
- Be randomized to receive either Oxytocin bolus or Oxytocin infusion during their cesarean section but after the baby is born.
- Be asked a question about their experience 2 hours after the surgery.
- Allow the research team to collect information about how they are doing from their hospital medical records.
Read the detailed description
Oxytocin is the most commonly used uterotonic agent worldwide to achieve adequate uterine tone and prevent postpartum hemorrhage. Over the past decade, the trend has been towards lowering the dose to reduce oxytocin-related adverse effects including nausea, hypotension, chest pain, EKG changes, and maternal death. However, the optimal strategy for oxytocin administration remains controversial. A prior study was conducted at Stony Brook University Hospital which investigated the difference between bolus versus infusion administration of oxytocin in elective cesarean section patients with a low risk of postpartum hemorrhage (PPH); the results of this randomized, double blinded clinical trial showed that bolus was not superior for adequate uterine tone at 2 minutes when compared to infusion of oxytocin, but blood loss was modestly lower and total oxytocin exposure was substantially lower in the bolus arm. Which makes the most logical next question: Does bolus oxytocin become more clinically meaningful in patients with higher baseline risk for uterine atony or hemorrhage. The investigators aim to address this question with the INBOX-HR study.
INBOX-HR acts as a continuing investigation on the difference between bolus versus infusion administration of oxytocin, specifically for patients that are at a high risk for postpartum hemorrhage. Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients at high risk for postpartum hemorrhage undergoing elective cesarean section. The primary objective of this study is to test the hypothesis that administration by bolus vs. infusion results in more rapid achievement of adequate uterine tone in this patient population. Secondary objectives include determining estimated blood loss, prevalence of hypotension, change in heart rate, nausea, vomiting, and patient satisfaction, and 0 - 10 uterine tone score.
- Conditions
- Postpartum Hemorrhage, Uterine Atony, Uterine Atony With Hemorrhage, Elective Cesarean Section
- Being tested
- Oxytocin Bolus or Oxytocin Infusion
- Keywords
- Oxytocin bolus vs infusion in elective cesarean section in patients at high risk for postpartum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin Bolus or Oxytocin InfusionDrug
On the day of surgery, patients will be randomized to receive either bolus or infusion administration of Oxytocin.
On the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin Bolus | Active comparator | Patients in the bolus arm will receive a 3 IU oxytocin IV bolus over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 0.9% Saline will be started at 225ml/hr. If uterine tone is considered inadequate after an additional 3 minutes, a second bolus of 3 IU oxytocin is given IV over 15 seconds. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 3 IU Oxytocin IV is given over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion consisting of oxytocin 3 IU/hr is started at 100ml/hrs and continued for a total of 4 hours, second line uterotonic agents (Methergine, Hemabate and/ or Cytotec) will be given, and the maintenance 0.9% Saline infusion will be changed to 450 ml/hr for a total of 1 hour, then changed to 38 ml/ hour for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of oxytocin 3 IU/hr (100ml/hr) is started and maintained Receives: Drug: Oxytocin Bolus or Oxytocin Infusion |
| Oxytocin Infusion | Active comparator | Patients in the infusion arm will receive a bolus of IV 0.9% Saline over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 18 IU/hr Oxytocin IV (225ml/hr). If uterine tone is considered inadequate after an additional 3 minutes, a second bolus of 0.9% Saline will be given IV over 15 seconds. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 0.9% Saline will be given IV over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion of 0.9% Saline will be started at 100 ml/hr for 4 hours, second line uterotonic agents (Methergine, Hemabate and/or Cytotec) will be given, and the Oxytocin infusion will be changed to 36 IU/hour (450 ml/hr) for a total of 1 hour, and then changed to 38 ml/hr for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of 0.9% Saline at 100 ml/hr will be started and maintained for 4 hours. Receives: Drug: Oxytocin Bolus or Oxytocin Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to uterine tone
Uterine tone will be assessed at 2 mins and then every minute thereafter until adequate uterine tone is attained but no more than 10 minutes maximum, by a blinded obstetrician. Uterine tone will be deemed adequate or inadequate by the blinded obstetrician. The time for the primary endpoint analysis is adequacy of uterine tone at 2 minutes after the baby is born/umbilical cord clamped.
Measured: 2 minutes after umbilical cord clamp until 10 minutes.
Secondary outcomes (8)
Estimated intraoperative blood loss
Measured: From the start to end of surgery
Changes in heart rate (beats per minute)
Measured: During uterine cord clamp and every 2 minutes thereafter until 10 minutes
Changes in blood pressure (mmHg)
Measured: During uterine cord clamp and every 2 minutes thereafter until 10 minutes.
Total dose of phenylephrine administered intraoperatively
Measured: From the start to end of surgery
Participants with need for additional uterotonic agents
Such as Methergine, Hemabate, and Cytotec
Measured: From oxytocin administration until end of surgery
0-10 Uterine tone score
Uterine tone score will be assessed at 2 mins and then every minute thereafter.
Measured: 2 minutes after uterine cord clamping until 10 minutes.
Participants with maternal side effects
Chest pain, nausea, vomiting
Measured: From oxytocin administration until end of surgery
Patient satisfaction questionnaire
The patient will be asked a question about their experience on a scale of 0-10 (0 being complete dissatisfaction, and 10 being highly satisfied).
Measured: 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, 2-arm, parallel study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany E. Angelo, D.O., Stony Brook University
- Investigators
- Tiffany E Angelo, DO, FASA, Principal investigator, Stony Brook University Hospital Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688512
- Sponsor's protocol ID
- IRB2026-00322
- Acronym
- INBOX-HR
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang LY, Wang J, Dong JH, Ping ZP, Chen XZ, Wei CN. The optimal oxytocin infusion rate for preventing uterine atony during cesarean delivery in elderly parturients with prior history of cesarean delivery. Front Pharmacol. 2023 Jul 28;14:1211693. doi: 10.3389/fphar.2023.1211693. eCollection 2023.
PubMed 37576820Oyelese Y, Ananth CV. Postpartum hemorrhage: epidemiology, risk factors, and causes. Clin Obstet Gynecol. 2010 Mar;53(1):147-56. doi: 10.1097/GRF.0b013e3181cc406d.
PubMed 20142652Joseph J, George SK, Daniel M, Ranjan RV. A randomised double-blind trial of minimal bolus doses of oxytocin for elective caesarean section under spinal anaesthesia: Optimal or not? Indian J Anaesth. 2020 Nov;64(11):960-964. doi: 10.4103/ija.IJA_377_20. Epub 2020 Nov 1.
PubMed 33487681Fuchs AR, Fuchs F, Husslein P, Soloff MS. Oxytocin receptors in the human uterus during pregnancy and parturition. Am J Obstet Gynecol. 1984 Nov 15;150(6):734-41. doi: 10.1016/0002-9378(84)90677-x.
PubMed 6093538Terblanche N, Otahal P, Messmer A, Wright P, Patel S, Nathan K, Sharman JE. An observational cohort study of 3 units versus 5 units slow intravenous bolus oxytocin in women undergoing elective caesarean delivery. J Physiol Pharmacol. 2017 Aug;68(4):547-553.
PubMed 29151071Balki M, Tsen L. Oxytocin protocols for cesarean delivery. Int Anesthesiol Clin. 2014 Spring;52(2):48-66. doi: 10.1097/AIA.0000000000000016. No abstract available.
PubMed 24667448Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PubMed 25103301
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT07688512
- Acronym / sponsor ID
- INBOX-HR / IRB2026-00322
- Conditions
- Postpartum Hemorrhage, Uterine Atony, Uterine Atony With Hemorrhage, Elective Cesarean Section
- Keywords
- Oxytocin bolus vs infusion in elective cesarean section in patients at high risk for postpartum hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 7 Jul 2026 (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.
The goal of this randomized, double-blind clinical trial is to learn if Oxytocin is most effective at achieving adequate uterine tone (important for preventing postpartum hemorrhage) when administered as a bolus or an infusion in patients at high-risk for postpartum hemorrhage in elective cesarean sections. The main questions that will be answered are:
- Is Oxytocin bolus more effective than Oxytocin infusion at achieving adequate uterine tone at 2 minutes after the baby is born and every minute thereafter?
- Does Oxytocin bolus cause less maternal side effects than Oxytocin infusion?
- Does Oxytocin bolus result in less blood loss than Oxytocin infusion in high risk for postpartum hemorrhage patients undergoing elective cesarean sections?
- Are patients more satisfied with their cesarean section when they receive Oxytocin bolus or Oxytocin infusion?
Researchers will compare the 2 methods of Oxytocin administration, bolus versus infusion, to see which method is more effective or if they are equally effective.
Participants will:
- Be randomized to receive either Oxytocin bolus or Oxytocin infusion during their cesarean section but after the baby is born.
- Be asked a question about their experience 2 hours after the surgery.
- Allow the research team to collect information about how they are doing from their hospital medical records.
Detailed description
Oxytocin is the most commonly used uterotonic agent worldwide to achieve adequate uterine tone and prevent postpartum hemorrhage. Over the past decade, the trend has been towards lowering the dose to reduce oxytocin-related adverse effects including nausea, hypotension, chest pain, EKG changes, and maternal death. However, the optimal strategy for oxytocin administration remains controversial. A prior study was conducted at Stony Brook University Hospital which investigated the difference between bolus versus infusion administration of oxytocin in elective cesarean section patients with a low risk of postpartum hemorrhage (PPH); the results of this randomized, double blinded clinical trial showed that bolus was not superior for adequate uterine tone at 2 minutes when compared to infusion of oxytocin, but blood loss was modestly lower and total oxytocin exposure was substantially lower in the bolus arm. Which makes the most logical next question: Does bolus oxytocin become more clinically meaningful in patients with higher baseline risk for uterine atony or hemorrhage. The investigators aim to address this question with the INBOX-HR study.
INBOX-HR acts as a continuing investigation on the difference between bolus versus infusion administration of oxytocin, specifically for patients that are at a high risk for postpartum hemorrhage. Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients at high risk for postpartum hemorrhage undergoing elective cesarean section. The primary objective of this study is to test the hypothesis that administration by bolus vs. infusion results in more rapid achievement of adequate uterine tone in this patient population. Secondary objectives include determining estimated blood loss, prevalence of hypotension, change in heart rate, nausea, vomiting, and patient satisfaction, and 0 - 10 uterine tone score.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, 2-arm, parallel study.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin Bolus | Active comparator | Drug: Oxytocin Bolus or Oxytocin InfusionPatients in the bolus arm will receive a 3 IU oxytocin IV bolus over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 0.9% Saline will be started at 225ml/hr. If uterine tone is considered inadequate after an additional 3 minutes, a second bolus of 3 IU oxytocin is given IV over 15 seconds. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 3 IU Oxytocin IV is given over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion consisting of oxytocin 3 IU/hr is started at 100ml/hrs and continued for a total of 4 hours, second line uterotonic agents (Methergine, Hemabate and/ or Cytotec) will be given, and the maintenance 0.9% Saline infusion will be changed to 450 ml/hr for a total of 1 hour, then changed to 38 ml/ hour for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of oxytocin 3 IU/hr (100ml/hr) is started and maintained |
| Oxytocin Infusion | Active comparator | Drug: Oxytocin Bolus or Oxytocin InfusionPatients in the infusion arm will receive a bolus of IV 0.9% Saline over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 18 IU/hr Oxytocin IV (225ml/hr). If uterine tone is considered inadequate after an additional 3 minutes, a second bolus of 0.9% Saline will be given IV over 15 seconds. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 0.9% Saline will be given IV over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion of 0.9% Saline will be started at 100 ml/hr for 4 hours, second line uterotonic agents (Methergine, Hemabate and/or Cytotec) will be given, and the Oxytocin infusion will be changed to 36 IU/hour (450 ml/hr) for a total of 1 hour, and then changed to 38 ml/hr for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of 0.9% Saline at 100 ml/hr will be started and maintained for 4 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Undergoing elective cesarean section under spinal anesthesia or combined spinal anesthesia (CSE)
- Patients must be able to provide written informed consent in either English or Spanish
- Parturient classified as high risk for postpartum hemorrhage as defined by the adapted California Maternal Quality Care Obstetric Hemorrhage Risk Screen
Key exclusion criteria (9 listed)
- Parturient in labor or ruptured membranes
- Patient does not possess the physical and mental capacity to provide informed consent
- Urgent or emergent cesarean sections
- Patients with a known major coagulopathy
- Patients with significant thrombocytopenia limiting neuraxial anesthesia (<70k)
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 |
|---|---|---|
| Oxytocin Bolus or Oxytocin InfusionOn the day of surgery, patients will be randomized to receive either bolus or infusion administration of Oxytocin. On the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded. | Drug | Oxytocin Bolus, Oxytocin Infusion |
Primary outcome
Time to uterine tone
Time frame: 2 minutes after umbilical cord clamp until 10 minutes.
Uterine tone will be assessed at 2 mins and then every minute thereafter until adequate uterine tone is attained but no more than 10 minutes maximum, by a blinded obstetrician. Uterine tone will be deemed adequate or inadequate by the blinded obstetrician. The time for the primary endpoint analysis is adequacy of uterine tone at 2 minutes after the baby is born/umbilical cord clamped.
8 secondary outcomes
Estimated intraoperative blood loss
Time frame: From the start to end of surgery
Changes in heart rate (beats per minute)
Time frame: During uterine cord clamp and every 2 minutes thereafter until 10 minutes
Changes in blood pressure (mmHg)
Time frame: During uterine cord clamp and every 2 minutes thereafter until 10 minutes.
Total dose of phenylephrine administered intraoperatively
Time frame: From the start to end of surgery
Participants with need for additional uterotonic agents
Time frame: From oxytocin administration until end of surgery
0-10 Uterine tone score
Time frame: 2 minutes after uterine cord clamping until 10 minutes.
Participants with maternal side effects
Time frame: From oxytocin administration until end of surgery
Patient satisfaction questionnaire
Time frame: 2 hours after surgery
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 3 Aug 2026.
- Background: PubMed 37576820Wang LY, Wang J, Dong JH, Ping ZP, Chen XZ, Wei CN. The optimal oxytocin infusion rate for preventing uterine atony during cesarean delivery in elderly parturients with prior history of cesarean delivery. Front Pharmacol. 2023 Jul 28;14:1211693. doi: 10.3389/fphar.2023.1211693. eCollection 2023.
- Background: PubMed 20142652Oyelese Y, Ananth CV. Postpartum hemorrhage: epidemiology, risk factors, and causes. Clin Obstet Gynecol. 2010 Mar;53(1):147-56. doi: 10.1097/GRF.0b013e3181cc406d.
- Background: PubMed 33487681Joseph J, George SK, Daniel M, Ranjan RV. A randomised double-blind trial of minimal bolus doses of oxytocin for elective caesarean section under spinal anaesthesia: Optimal or not? Indian J Anaesth. 2020 Nov;64(11):960-964. doi: 10.4103/ija.IJA_377_20. Epub 2020 Nov 1.
- Background: PubMed 6093538Fuchs AR, Fuchs F, Husslein P, Soloff MS. Oxytocin receptors in the human uterus during pregnancy and parturition. Am J Obstet Gynecol. 1984 Nov 15;150(6):734-41. doi: 10.1016/0002-9378(84)90677-x.
- Background: PubMed 29151071Terblanche N, Otahal P, Messmer A, Wright P, Patel S, Nathan K, Sharman JE. An observational cohort study of 3 units versus 5 units slow intravenous bolus oxytocin in women undergoing elective caesarean delivery. J Physiol Pharmacol. 2017 Aug;68(4):547-553.
- Background: PubMed 24667448Balki M, Tsen L. Oxytocin protocols for cesarean delivery. Int Anesthesiol Clin. 2014 Spring;52(2):48-66. doi: 10.1097/AIA.0000000000000016. No abstract available.
- Background: PubMed 25103301Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
- 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.
Tiffany E Angelo, DO, FASA principal investigator
Stony Brook University Hospital Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin Bolus or Oxytocin Infusion in people with Postpartum Hemorrhage and Uterine Atony, run by Stony Brook University.
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 9 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Tiffany E Angelo, DO, FASA (631-759-0328, tiffany.angelo@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to uterine tone (time frame: 2 minutes after umbilical cord clamp until 10 minutes.). 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 NCT07688512, which also lists 7 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 3 Aug 2026.