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NOT YET RECRUITING
NCT06691945
PHASE3

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2024-11-11

Completion Date

2027-05-01

Last Updated

2024-11-18

Healthy Volunteers

No

Interventions

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.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States