Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage
Phase 3
Not yet recruiting
- Conditions
- Postpartum Hemorrhage
- Registration Number
- NCT06691945
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 700
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants who have estimated or quantified blood loss of 1,500 mL or more from delivery admission to discharge (average of 3 days post delivery) Number of participants who have transfusion of any blood products from delivery admission to discharge or up to 12 weeks post delivery Number of participants who have hysterectomy from delivery admission to discharge or up to 12 weeks post delivery
- Secondary Outcome Measures
Name Time Method Number of mothers who use uterotonics, in addition to oxytocin from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Estimated blood loss(mL) post delivery (from immediately after delivery to upto 2 hours after delivery) Quantitative blood loss(mL) post delivery(from immediately after delivery to upto 2 hours after delivery) Delta change in hemoglobin of mothers pre delivery, post partum day 1 Number of mothers who have cesarean deliveries from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Number of mothers who need Mechanical tamponade from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Number of mothers who have surgical interventions (O'Leary, B 'Lynch or uterine arterial embolization) from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Number of mothers who have Chorioamnionitis from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Number of mothers who have endometritis from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Number of mothers who have wound complications (if cesarean delivery) from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Number of mothers who are admitted to intensive care unit from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Number of deaths from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period Number of neonates with Apgar < 7 at 5 minutes after delivery Number of neonates that have a seizure delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications Number of neonates that have meconium aspiration syndrome delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications Number of neonates that have Ventilation > 6 hrs delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications Number of neonates that have Bronchopulmonary dysplasia delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications Number of neonates that have Necrotizing enterocolitis delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications Number of neonates that have Sepsis delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications Number of stillbirths at delivery Number of deaths of neonates within 27 days of birth
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States