Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06691945
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Postpartum Hemorrhage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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

Key Dates

Start date
Nov 11, 2024
Status verified
Nov 2024
Primary completion
Nov 11, 2026
Completion
May 1, 2027

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Prophylactic amnioinfusion
  • No Intervention: Routine Care

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Sarah Mehl, MD
[email protected]
712-500-6412
Ahmed S Zaki Moustafa
[email protected]
(713) 500-6412

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The University of Texas Health Science Center at Houston· Houston, TX

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