Postpartum HemorrhagePhase 3PURPOSENCT06691945
Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage
A Phase 3 study testing Saline delivered using an intrauterine pressure catheter (IUPC) in people with Postpartum Hemorrhage, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated or quantified blood loss of 1,500 mL or more, ii) transfusion of any blood products or iii) hysterectomy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Saline delivered using an intrauterine pressure catheter (IUPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 1 May 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singletons with a gestational age of 34.0 weeks or more
- Labor (spontaneous or medical induction)
- Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)
Who cannot join
- Scheduled cesarean delivery
- Multiple gestations
- Delivery at < 34.0 weeks
- Contraindication to place intrauterine pressure catheter (e.g. HIV)
- Incarcerated subjects
- Major fetal anomalies requiring neonatal surgical intervention
- Stillbirth on admission
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
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sarah Mehl, MD, 712-500-6412, Sarah.Theriot@uth.tmc.edu
Ahmed S Zaki Moustafa, (713) 500-6412, Ahmed.ZakiMoustafa@uth.tmc.edu
About this study
Official title: Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)
The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated or quantified blood loss of 1,500 mL or more, ii) transfusion of any blood products or iii) hysterectomy
- Conditions
- Postpartum Hemorrhage
- Being tested
- Saline delivered using an intrauterine pressure catheter (IUPC)
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline delivered using an intrauterine pressure catheter (IUPC)Combination product
An intrauterine pressure catheter (IUPC) will be placed in participants after membrane rupture, or at 4 cm if membranes previously ruptured. A 300cc bolus of normal saline will be administered. A continuous rate of 100 cc/hr of normal saline will continue until delivery to prevent Postpartum Hemorrhage. If the IUPC is dislodged, it will be replaced by a trained clinician.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic amnioinfusion | Experimental | Not described Receives: Combination Product: Saline delivered using an intrauterine pressure catheter (IUPC) |
| Routine Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have estimated or quantified blood loss of 1,500 mL or more
Measured: from delivery admission to discharge (average of 3 days post delivery)
Number of participants who have transfusion of any blood products
Measured: from delivery admission to discharge or up to 12 weeks post delivery
Number of participants who have hysterectomy
Measured: from delivery admission to discharge or up to 12 weeks post delivery
Secondary outcomes (21)
Number of mothers who use uterotonics, in addition to oxytocin
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Estimated blood loss(mL)
Measured: post delivery (from immediately after delivery to upto 2 hours after delivery)
Quantitative blood loss(mL)
Measured: post delivery(from immediately after delivery to upto 2 hours after delivery)
Delta change in hemoglobin of mothers
Measured: pre delivery, post partum day 1
Number of mothers who have cesarean deliveries
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who need Mechanical tamponade
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have surgical interventions (O'Leary, B 'Lynch or uterine arterial embolization)
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have Chorioamnionitis
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have endometritis
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have wound complications (if cesarean delivery)
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who are admitted to intensive care unit
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of deaths
Measured: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of neonates with Apgar < 7
Measured: at 5 minutes after delivery
Number of neonates that have a seizure
Measured: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have meconium aspiration syndrome
Measured: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Ventilation > 6 hrs
Measured: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Bronchopulmonary dysplasia
Measured: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Necrotizing enterocolitis
Measured: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Sepsis
Measured: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of stillbirths
Measured: at delivery
Number of deaths of neonates
Measured: within 27 days of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start11 Nov 2024 (estimated)
- Primary completion11 Nov 2026 (estimated)
- Study completion1 May 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.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mehl, The University of Texas Health Science Center, Houston
- Investigators
- Sarah Mehl, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691945
- Sponsor's protocol ID
- HSC-MS-24-0439
- Acronym
- PURPOSE
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)
- ClinicalTrials.gov ID
- NCT06691945
- Acronym / sponsor ID
- PURPOSE / HSC-MS-24-0439
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 11 Nov 2024 (estimated)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Nov 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.
The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated or quantified blood loss of 1,500 mL or more, ii) transfusion of any blood products or iii) hysterectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic amnioinfusion | Experimental | Combination Product: Saline delivered using an intrauterine pressure catheter (IUPC) |
| Routine Care | No intervention | – |
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)
- Singletons with a gestational age of 34.0 weeks or more
- Labor (spontaneous or medical induction)
- Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)
Key exclusion criteria (7 listed)
- Scheduled cesarean delivery
- Multiple gestations
- Delivery at < 34.0 weeks
- Contraindication to place intrauterine pressure catheter (e.g. HIV)
- Incarcerated subjects
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 |
|---|---|---|
| Saline delivered using an intrauterine pressure catheter (IUPC)An intrauterine pressure catheter (IUPC) will be placed in participants after membrane rupture, or at 4 cm if membranes previously ruptured. A 300cc bolus of normal saline will be administered. A continuous rate of 100 cc/hr of normal saline will continue until delivery to prevent Postpartum Hemorrhage. If the IUPC is dislodged, it will be replaced by a trained clinician. | Combination product | Prophylactic amnioinfusion |
Primary outcome
Number of participants who have estimated or quantified blood loss of 1,500 mL or more
Time frame: from delivery admission to discharge (average of 3 days post delivery)
Number of participants who have transfusion of any blood products
Time frame: from delivery admission to discharge or up to 12 weeks post delivery
Number of participants who have hysterectomy
Time frame: from delivery admission to discharge or up to 12 weeks post delivery
21 secondary outcomes
Number of mothers who use uterotonics, in addition to oxytocin
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Estimated blood loss(mL)
Time frame: post delivery (from immediately after delivery to upto 2 hours after delivery)
Quantitative blood loss(mL)
Time frame: post delivery(from immediately after delivery to upto 2 hours after delivery)
Delta change in hemoglobin of mothers
Time frame: pre delivery, post partum day 1
Number of mothers who have cesarean deliveries
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who need Mechanical tamponade
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have surgical interventions (O'Leary, B 'Lynch or uterine arterial embolization)
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have Chorioamnionitis
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have endometritis
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have wound complications (if cesarean delivery)
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who are admitted to intensive care unit
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of deaths
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of neonates with Apgar < 7
Time frame: at 5 minutes after delivery
Number of neonates that have a seizure
Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have meconium aspiration syndrome
Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Ventilation > 6 hrs
Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Bronchopulmonary dysplasia
Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Necrotizing enterocolitis
Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Sepsis
Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of stillbirths
Time frame: at delivery
Number of deaths of neonates
Time frame: within 27 days of birth
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 18 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
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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
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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.
Sarah Mehl, MD principal investigator
The University of Texas Health Science Center, Houston
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 Saline delivered using an intrauterine pressure catheter (IUPC) in people with Postpartum Hemorrhage, run by The University of Texas Health Science Center, Houston 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 7 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 18 Nov 2024. 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?
Contact Sarah Mehl, MD ((712) 500-6412, Sarah.Theriot@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have estimated or quantified blood loss of 1,500 mL or more (time frame: from delivery admission to discharge (average of 3 days post delivery)). The study lists 3 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 18 Nov 2024.