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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic amnioinfusion | Experimental |
| |
| Routine Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline delivered using an intrauterine pressure catheter (IUPC) | Combination Product | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Mehl, MD | Contact | (712) 500-6412 | Sarah.Theriot@uth.tmc.edu | |
| Ahmed S Zaki Moustafa | Contact | (713) 500-6412 | Ahmed.ZakiMoustafa@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Mehl, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| 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 |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |