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Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage

RecruitingNAAges 18 Years - 44 YearsFemaleWomen and Infants Hospital of Rhode Island
NCT05382403 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years or older * Delivery at 34 weeks or greater * Cumulative blood loss \>1000ml within 24 hours after delivery * Uterine atony * Receipt of first-line uterotonics * Cervix at least 3cm dilated at cesarean section Exclusion Criteria: * Patient unwilling or unable to provide informed consent * Retained placenta or other known cause of postpartum hemorrhage * Placenta accreta spectrum * Coagulopathy * Rupture uterus * Surgical management immediately needed for life-threatening bleeding * Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection
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What it tests

  • Jada® System
  • Standard care
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Where

2 sites
Komfo Anokye Teaching Hospital
Kumasi, Ghana
Korle-bu Teaching Hospital
Accra, Ghana
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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