Clinical trial NCT06691945: Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage
Official title: Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Postpartum Hemorrhage
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who have estimated or quantified blood loss of 1,500 mL or more
timeFrame: from delivery admission to discharge (average of 3 days post delivery)
measure: Number of participants who have transfusion of any blood products
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery
measure: Number of participants who have hysterectomy
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery
Secondary outcomes:
measure: Number of mothers who use uterotonics, in addition to oxytocin
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Estimated blood loss(mL)
timeFrame: post delivery (from immediately after delivery to upto 2 hours after delivery)
measure: Quantitative blood loss(mL)
timeFrame: post delivery(from immediately after delivery to upto 2 hours after delivery)
measure: Delta change in hemoglobin of mothers
timeFrame: pre delivery, post partum day 1
measure: Number of mothers who have cesarean deliveries
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Number of mothers who need Mechanical tamponade
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Number of mothers who have surgical interventions (O'Leary, B 'Lynch or uterine arterial embolization)
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Number of mothers who have Chorioamnionitis
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Number of mothers who have endometritis
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Number of mothers who have wound complications (if cesarean delivery)
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Number of mothers who are admitted to intensive care unit
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Number of deaths
timeFrame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
measure: Number of neonates with Apgar < 7
timeFrame: at 5 minutes after delivery
measure: Number of neonates that have a seizure
timeFrame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
measure: Number of neonates that have meconium aspiration syndrome
timeFrame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
measure: Number of neonates that have Ventilation > 6 hrs
timeFrame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
measure: Number of neonates that have Bronchopulmonary dysplasia
timeFrame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
measure: Number of neonates that have Necrotizing enterocolitis
timeFrame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
measure: Number of neonates that have Sepsis
timeFrame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
measure: Number of stillbirths
timeFrame: at delivery
measure: Number of deaths of neonates
timeFrame: within 27 days of birth
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sarah Mehl, MD
role: PRINCIPAL_INVESTIGATOR
References: