Not yet recruiting NCT06691945
Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saline delivered using an intrauterine pressure catheter (IUPC).
- Who it may be relevant to
- Registry conditions: Postpartum Hemorrhage. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)
Overview
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 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.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT06691945 · HSC-MS-24-0439