Postpartum HemorrhagePhase 3NCT05245227
Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage
A Phase 3 study testing Sublingual Misoprostol and IV Oxytocin in people with Postpartum Hemorrhage, run by Stony Brook University at 1 site in United States.
Trial summary
To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage. There have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Sublingual Misoprostol and IV Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,358 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2025to 1 Jan 2027
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women 18 years and older admitted to delivery at Stony Brook University hospital who agree to participate in the study
Who cannot join
- Women under 18 years old
- Women with known coagulation disorders
- Women with planned cesarean hysterectomy
- Women with known placental accreta spectrum disorders
- Women with known allergy to prostaglandins
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
Stony Brook University
Stony Brook, New York, 11794
Erin Cassella, 631-444-7650, erin.casella@stonybrookmedicine.edu
James Bernasko, MD
About this study
Official title: A Randomized Controlled Trial of Double Simultaneous Uterotonic Agents (Misoprostol Plus Intravenous Oxytocin) Versus Single Agent Regimen (Intravenous Oxytocin Only) to Prevent Early Postpartum Hemorrhage
To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage.
There have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage.
Specific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage.
Specific Aim 2: Determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).
Read the detailed description
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality in the world, accounting for a quarter of all maternal deaths globally. Most cases of PPH can be attributed to uterine atony, failure of the uterus to contract in the immediate postpartum period. Efforts to prevent uterine atony and thereby PPH have focused on active clinical management of the third stage of labor (the period between delivery of the infant and placenta) and the administration of uterotonic agents (medication that induces uterine contraction). Universal standard of care to prevent postpartum hemorrhage, according to the American College of Obstetrics and Gynecologists and World Health Organization includes various dose infusions of oxytocin. Additional uterotonics are given if necessary, according to noted blood loss and uterine tone. The best uterotonic(s), combination, route, and dose, however, remain actively debated. Randomized controlled trials have not proven that misoprostol is superior to oxytocin or methergine to treat postpartum hemorrhage, but it is a medication that is often used conjunctively or after other agents fail. A Cochrane review of treatment of primary postpartum hemorrhage revealed that oxytocin, ergot alkaloids (i.e., methergine), and combined oxytocin-ergot alkaloid administration were equally effective in preventing PPH in the general obstetric population, whereas prostaglandins alone (i.e., misoprostol) were not. In an effort to determine the benefit of a simultaneous double uterotonic agent regimen in the prevention of PPH, the investigators propose to conduct a controlled trial in which women will be randomly assigned to an intervention group (buccal misoprostol and intravenous oxytocin administered simultaneously) versus a control group (standard of care, intravenous oxytocin alone).
- Conditions
- Postpartum Hemorrhage
- Being tested
- Sublingual Misoprostol, IV Oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual MisoprostolDrug
Misoprostol 400 mcg sublingual
IV OxytocinDrug
40 units IV Oxytocin in 1000 mL normal saline
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Oxytocin only | Active comparator | Patients will receive standard postpartum Oxytocin IV per protocol Receives: Drug: IV Oxytocin |
| Misoprostol plus intravenous Oxytocin | Experimental | Patients will receive standard postpartum Oxytocin IV per protocol and also be given Misoprostol 400 mcg sublingual Receives: Drug: Sublingual Misoprostol; Drug: IV Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage blood loss volume.
Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Determine serious adverse outcomes of a double simultaneous uterotonic agent regimen (misoprostol and oxytocin) versus a single agent (oxytocin only) that is documented in the medical record.
Determine any potential side effects of a double simultaneous uterotonic agent regimen (misoprostol and oxytocin) versus a single agent (oxytocin only).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start27 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Bernasko, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245227
- Sponsor's protocol ID
- IRB2021-00142
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2021
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Double Simultaneous Uterotonic Agents (Misoprostol Plus Intravenous Oxytocin) Versus Single Agent Regimen (Intravenous Oxytocin Only) to Prevent Early Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT05245227
- Acronym / sponsor ID
- IRB2021-00142
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,358 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 17 Feb 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.
To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage.
There have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage.
Specific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage.
Specific Aim 2: Determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).
Detailed description
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality in the world, accounting for a quarter of all maternal deaths globally. Most cases of PPH can be attributed to uterine atony, failure of the uterus to contract in the immediate postpartum period. Efforts to prevent uterine atony and thereby PPH have focused on active clinical management of the third stage of labor (the period between delivery of the infant and placenta) and the administration of uterotonic agents (medication that induces uterine contraction). Universal standard of care to prevent postpartum hemorrhage, according to the American College of Obstetrics and Gynecologists and World Health Organization includes various dose infusions of oxytocin. Additional uterotonics are given if necessary, according to noted blood loss and uterine tone. The best uterotonic(s), combination, route, and dose, however, remain actively debated. Randomized controlled trials have not proven that misoprostol is superior to oxytocin or methergine to treat postpartum hemorrhage, but it is a medication that is often used conjunctively or after other agents fail. A Cochrane review of treatment of primary postpartum hemorrhage revealed that oxytocin, ergot alkaloids (i.e., methergine), and combined oxytocin-ergot alkaloid administration were equally effective in preventing PPH in the general obstetric population, whereas prostaglandins alone (i.e., misoprostol) were not. In an effort to determine the benefit of a simultaneous double uterotonic agent regimen in the prevention of PPH, the investigators propose to conduct a controlled trial in which women will be randomly assigned to an intervention group (buccal misoprostol and intravenous oxytocin administered simultaneously) versus a control group (standard of care, intravenous oxytocin alone).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Oxytocin only | Active comparator | Drug: IV OxytocinPatients will receive standard postpartum Oxytocin IV per protocol |
| Misoprostol plus intravenous Oxytocin | Experimental | Drug: Sublingual Misoprostol, Drug: IV OxytocinPatients will receive standard postpartum Oxytocin IV per protocol and also be given Misoprostol 400 mcg sublingual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women 18 years and older admitted to delivery at Stony Brook University hospital who agree to participate in the study
Key exclusion criteria (5 listed)
- Women under 18 years old
- Women with known coagulation disorders
- Women with planned cesarean hysterectomy
- Women with known placental accreta spectrum disorders
- Women with known allergy to prostaglandins
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 |
|---|---|---|
| Sublingual MisoprostolMisoprostol 400 mcg sublingual | Drug | Misoprostol plus intravenous Oxytocin |
| IV Oxytocin40 units IV Oxytocin in 1000 mL normal saline | Drug | Intravenous Oxytocin only, Misoprostol plus intravenous Oxytocin |
Primary outcome
Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage blood loss volume.
Time frame: through study completion, an average of 1 year
Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage.
1 secondary outcome
Determine serious adverse outcomes of a double simultaneous uterotonic agent regimen (misoprostol and oxytocin) versus a single agent (oxytocin only) that is documented in the medical record.
Time frame: through study completion, an average of 1 year
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 4 May 2025.
- 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 Phase 3 study testing Sublingual Misoprostol and IV Oxytocin in people with Postpartum Hemorrhage, run by Stony Brook 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 1 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage blood loss volume. (time frame: through study completion, an average of 1 year). 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 4 May 2025.