Prophylactic Amnioinfusion for Preventing Postpartum Hemorrhage

This study is testing if giving saline (salt water) through an intrauterine pressure catheter (IUPC), a small tube placed in the uterus, can help prevent severe postpartum hemorrhage (PPH), which is heavy bleeding after childbirth. You might be able to join if you are at least 18 years old, are pregnant with one baby (singleton) at 34 weeks or more, are in labor, and have a medium or high risk for PPH. The study aims to see if this treatment can reduce the number of people who experience significant blood loss (1,500 mL or more), need blood transfusions, or require a hysterectomy (removal of the uterus) after delivery. The study plans to enroll about 700 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 700 participants. It is designed to compare the effects of saline delivered via an IUPC.
What's involved
If you participate, an IUPC will be placed after your water breaks or at 4 cm dilation. You will receive a 300cc bolus of normal saline, followed by a continuous rate of 100 cc/hr until delivery.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track outcomes like blood loss, transfusions, and hysterectomy from delivery admission to discharge (about 3 days post-delivery) or up to 12 weeks post-delivery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06691945

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage

Not Yet Recruiting
PHASE3Ages 18+InterventionalPrevention
The University of Texas Health Science Center, Houston
~700 participants
Updated 2024-11-18 on ClinicalTrials.gov
What's tested:Saline delivered using an intrauterine pressure catheter (IUPC)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who have estimated or quantified blood loss of 1,500 mL or more
Measured over from delivery admission to discharge (average of 3 days post delivery)
+2 more outcomes measured
Postpartum Hemorrhage
1 sites across 1 states
Texas1
  • Sarah Mehl, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

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

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
  • Number of participants who have estimated or quantified blood loss of 1,500 mL or morefrom delivery admission to discharge (average of 3 days post delivery)
  • Number of participants who have transfusion of any blood productsfrom delivery admission to discharge or up to 12 weeks post delivery
  • Number of participants who have hysterectomyfrom delivery admission to discharge or up to 12 weeks post delivery