A Phase 3 interventional study of Saline delivered using an intrauterine pressure catheter (IUPC) in Postpartum Hemorrhage, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by The University of Texas Health Science Center, Houston · Phase 3, Interventional, and Prevention
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
456 studies on the registry are indexed under Postpartum Hemorrhage; 77 are open to participants now.
This study's planned enrollment of 700 is above the median of 148 across 348 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Exclusion Criteria:
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.
Number of participants who have estimated or quantified blood loss of 1,500 mL or more
Time frame: from delivery admission to discharge (average of 3 days post delivery)
Number of participants who have transfusion of any blood products
Time frame: from delivery admission to discharge or up to 12 weeks post delivery
Number of participants who have hysterectomy
Time frame: from delivery admission to discharge or up to 12 weeks post delivery
Number of mothers who use uterotonics, in addition to oxytocin
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Estimated blood loss(mL)
Time frame: post delivery (from immediately after delivery to upto 2 hours after delivery)
Quantitative blood loss(mL)
Time frame: post delivery(from immediately after delivery to upto 2 hours after delivery)
Delta change in hemoglobin of mothers
Time frame: pre delivery, post partum day 1
Number of mothers who have cesarean deliveries
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of deaths
Time frame: 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
Time frame: at 5 minutes after delivery
Number of neonates that have a seizure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of stillbirths
Time frame: at delivery
Number of deaths of neonates
Time frame: within 27 days of birth
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Nov 2026, 24 months later.
Of 18 phase 3 interventional studies under Postpartum Hemorrhage, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 26. This study's planned 24 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston →