Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage (PURPOSE)

The University of Texas System (UT)

Status and phase: Not yet enrolling; Phase 3

Conditions: Postpartum Hemorrhage

Treatments: Combination Product: Saline delivered using an intrauterine pressure catheter (IUPC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06691945

HSC-MS-24-0439

Details and patient eligibility

About

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

Enrollment: 700 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Prophylactic amnioinfusion

Experimental group

Treatment:

Combination Product: Saline delivered using an intrauterine pressure catheter (IUPC)

Routine Care

No Intervention group