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New treatment option for Postpartum Hemorrhage
Official title Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
ClinicalTrials.gov ID: NCT05382403
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 44, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kumasi, Ashanti Region, Ghana
- Accra, Greater Accra Region, Ghana
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 44 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kumasi, Ashanti Region, Ghana; Accra, Greater Accra Region, Ghana. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.