Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage
NCT ID: NCT06691945
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
700 participants
INTERVENTIONAL
2024-11-11
2027-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Prophylactic amnioinfusion
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.
Routine Care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Labor (spontaneous or medical induction)
* Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Sarah Mehl
Fellow
Principal Investigators
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Sarah Mehl, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-24-0439
Identifier Type: -
Identifier Source: org_study_id
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