NCT06691945

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2024-11-11
• Primary completion: 2026-11-11
• Completion: 2027-05-01
• First posted: 2024-11-18
• Last updated: 2024-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study