Postpartum Hemorrhage
Conditions
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
Interventions
COMBINATION_PRODUCTSaline 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Estimated blood loss(mL) | post delivery (from immediately after delivery to upto 2 hours after delivery) |
| 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 |
| Quantitative blood loss(mL) | post delivery(from immediately after delivery to upto 2 hours 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 |
| Number of neonates with Apgar < 7 | at 5 minutes after delivery |
| Delta change in hemoglobin of mothers | pre delivery, post partum day 1 |
| 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 |
Countries
United States
Contacts
Primary ContactSarah Mehl, MD
Backup ContactAhmed S Zaki Moustafa
Outcome results
None listed