Postpartum HemorrhagePhase 2HOLDOUTNCT06550089
High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth
A Phase 2 study testing Oxytocin in people with Postpartum Hemorrhage and Pregnancy Complications, run by University of Chicago.
Trial summary
This is a study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage, Pregnancy Complications, Cesarean Section Complications
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or greater
- English or Spanish speaking
- Individuals undergoing a scheduled or unscheduled cesarean delivery
Who cannot join
- Patient on therapeutic anticoagulation
- Patient with hypertensive disorder of pregnancy or chronic hypertension
- Patient with preexisting bleeding disorder
- Patient with preexisting cardiac disease
- Patient with severe asthma, defined as the need for two or more agents for disease control, or bronchospasm
- Patient undergoing planned cesarean hysterectomy
About this study
Official title: A Pilot Study of High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth (HOLDOUT Pilot)
This is a study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.
Read the detailed description
Due to risks of postpartum hemorrhage, defined by the American College of Obstetricians and Gynecologists, as an estimated or quantitative blood loss of greater than 1000 milliliters, uterotonics, or medications aimed at increasing uterine tone and reducing blood loss at the time of birth, are commonly administered. Based on a Cochrane network meta-analysis, most organizations endorse the administration of 10 international units (IU) of oxytocin during delivery. However, the World Health Organization specifies that during a cesarean birth, the 10 IU should be administered using a bolus dose and an infusion, though an optimal infusion rate has yet to be agreed upon.
The use of a higher rate of oxytocin may confer a reduction in overall blood loss and subsequent maternal health outcomes (e.g., postoperative anemia, hypotension) and healthcare resource utilization (e.g., need for additional uterotonics and surgical procedures to control bleeding, administration of blood products). However, it is unknown whether it is feasible to conduct a randomized controlled trial to investigate the use of high (i.e., oxytocin rate of 900 mL/hr immediately after the delivery of the placenta) versus low-dose oxytocin (i.e., 300 mL/hr for planned cesarean births or 600 mL/hr for intrapartum cesarean births).
- Being tested
- Oxytocin
- Keywords
- oxytocin, cesarean delivery, postpartum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| High-dose oxytocin | Experimental | 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery Receives: Drug: Oxytocin |
| Low-dose oxytocin | Active comparator | For unlabored cesarean births: 300 mL/hr (18 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery
For laboring cesarean births: 600 mL/hr (36 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen failure rate
Number of individuals who are eligible for the study but do not consent to participate
Measured: Within 8 hours prior to cesarean delivery
Fidelity rate
Frequency of fidelity to the trial
Measured: Within 8 hours prior to cesarean delivery
Trial retention rate
Frequency of participant completion of all study visits
Measured: Up to 6 weeks after cesarean delivery
Acceptability of the intervention
Frequency of acceptability of the intervention by both participants and their providers
Measured: Up to 6 weeks after cesarean delivery
Secondary outcomes (14)
Maternal flushing
Measured: During and up to 6 hours after cesarean delivery
Maternal hypotension
Mean arterial blood pressure less than 65 mmHg
Measured: During and up to 6 hours after cesarean delivery
Maternal nausea/vomiting
Measured: During and up to 6 hours after cesarean delivery
Myocardial ischemia
Measured: During and up to 24 hours after cesarean delivery
Cardiac arrhythmia
Measured: During and up to 24 hours after cesarean delivery
Quantitative blood loss greater than 1 liter
Measured: Within 24 hours after cesarean delivery
Need for blood product transfusion, inclusive of type and number of blood products transfused
Measured: Within 4 days after cesarean delivery
Frequency of increase in oxytocin rate in low-dose arm
Measured: During and up to 6 hours after cesarean delivery
Additional use of uterotonics and/or tranexamic acid
Measured: During and up to 24 hours after cesarean delivery
Placement of intrauterine balloon tamponade or suction device
Measured: During and up to 24 hours after cesarean delivery
Surgical management of hemorrhage, inclusive of hysterectomy
Measured: During and up to 24 hours after cesarean delivery
Intensive care unit admission
Measured: During and up to 24 hours after cesarean delivery
Maternal death
Measured: During and up to 6 weeks after cesarean delivery
Readmission to the hospital or reoperation
Measured: Up to 6 weeks after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Study will be restarted at a later date
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Ashish Premkumar, MD, PhD, Principal investigator, University of ChicagoAnna Palatnik, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550089
- Sponsor's protocol ID
- IRB24-0398
- Acronym
- HOLDOUT
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared by the us, the investigators, upon request by other researchers
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth (HOLDOUT Pilot)
- ClinicalTrials.gov ID
- NCT06550089
- Acronym / sponsor ID
- HOLDOUT / IRB24-0398
- Keywords
- oxytocin, cesarean delivery, postpartum hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study will be restarted at a later date
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Aug 2024 (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 study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.
Detailed description
Due to risks of postpartum hemorrhage, defined by the American College of Obstetricians and Gynecologists, as an estimated or quantitative blood loss of greater than 1000 milliliters, uterotonics, or medications aimed at increasing uterine tone and reducing blood loss at the time of birth, are commonly administered. Based on a Cochrane network meta-analysis, most organizations endorse the administration of 10 international units (IU) of oxytocin during delivery. However, the World Health Organization specifies that during a cesarean birth, the 10 IU should be administered using a bolus dose and an infusion, though an optimal infusion rate has yet to be agreed upon.
The use of a higher rate of oxytocin may confer a reduction in overall blood loss and subsequent maternal health outcomes (e.g., postoperative anemia, hypotension) and healthcare resource utilization (e.g., need for additional uterotonics and surgical procedures to control bleeding, administration of blood products). However, it is unknown whether it is feasible to conduct a randomized controlled trial to investigate the use of high (i.e., oxytocin rate of 900 mL/hr immediately after the delivery of the placenta) versus low-dose oxytocin (i.e., 300 mL/hr for planned cesarean births or 600 mL/hr for intrapartum cesarean births).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose oxytocin | Experimental | Drug: Oxytocin900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery |
| Low-dose oxytocin | Active comparator | Drug: OxytocinFor unlabored cesarean births: 300 mL/hr (18 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery For laboring cesarean births: 600 mL/hr (36 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or greater
- English or Spanish speaking
- Individuals undergoing a scheduled or unscheduled cesarean delivery
Key exclusion criteria (6 listed)
- Patient on therapeutic anticoagulation
- Patient with hypertensive disorder of pregnancy or chronic hypertension
- Patient with preexisting bleeding disorder
- Patient with preexisting cardiac disease
- Patient with severe asthma, defined as the need for two or more agents for disease control, or bronchospasm
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 |
|---|---|---|
| OxytocinOxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage. | Drug | High-dose oxytocin, Low-dose oxytocin |
Primary outcome
Screen failure rate
Time frame: Within 8 hours prior to cesarean delivery
Number of individuals who are eligible for the study but do not consent to participate
Fidelity rate
Time frame: Within 8 hours prior to cesarean delivery
Frequency of fidelity to the trial
Trial retention rate
Time frame: Up to 6 weeks after cesarean delivery
Frequency of participant completion of all study visits
Acceptability of the intervention
Time frame: Up to 6 weeks after cesarean delivery
Frequency of acceptability of the intervention by both participants and their providers
14 secondary outcomes
Maternal flushing
Time frame: During and up to 6 hours after cesarean delivery
Maternal hypotension
Time frame: During and up to 6 hours after cesarean delivery
Maternal nausea/vomiting
Time frame: During and up to 6 hours after cesarean delivery
Myocardial ischemia
Time frame: During and up to 24 hours after cesarean delivery
Cardiac arrhythmia
Time frame: During and up to 24 hours after cesarean delivery
Quantitative blood loss greater than 1 liter
Time frame: Within 24 hours after cesarean delivery
Need for blood product transfusion, inclusive of type and number of blood products transfused
Time frame: Within 4 days after cesarean delivery
Frequency of increase in oxytocin rate in low-dose arm
Time frame: During and up to 6 hours after cesarean delivery
Additional use of uterotonics and/or tranexamic acid
Time frame: During and up to 24 hours after cesarean delivery
Placement of intrauterine balloon tamponade or suction device
Time frame: During and up to 24 hours after cesarean delivery
Surgical management of hemorrhage, inclusive of hysterectomy
Time frame: During and up to 24 hours after cesarean delivery
Intensive care unit admission
Time frame: During and up to 24 hours after cesarean delivery
Maternal death
Time frame: During and up to 6 weeks after cesarean delivery
Readmission to the hospital or reoperation
Time frame: Up to 6 weeks after cesarean delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Yes. IPD will be shared by the us, the investigators, upon request by other researchers
Related trials for Postpartum Hemorrhage
Not yet recruiting
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RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum 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
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Ashish Premkumar, MD, PhD principal investigator
University of Chicago
Anna Palatnik, MD principal investigator
Medical College of Wisconsin
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Postpartum Hemorrhage and Pregnancy Complications, run by University of Chicago.
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: withdrawn, as of the sponsor's last update on 10 Dec 2024. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Screen failure rate (time frame: Within 8 hours prior to cesarean delivery). The study lists 4 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 10 Dec 2024.