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New treatment option for Postpartum Haemorrhage (PPH)
Official title EVE TRIAL , ALMA SYSTAM
ClinicalTrials.gov ID: NCT06646653
What this study is testing
- What it's testing
- abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Adult Female, 18 years of age or older at time of consent.
- Able to understand and provide informed consent to participate in the study.
- Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.
- EBL, determined when investigator is ready to have the Alma peel pack opened: Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500...
- Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may...
You likely can't join if
- EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened.
- Delivery at a gestational age \< 34 weeks.
- For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma.
- PPH that the investigator determines to require more aggressive treatment, including any of the following:
- hysterectomy;
- b-lynch suture;
See the full eligibility criteria
- Adult Female, 18 years of age or older at time of consent.
- Able to understand and provide informed consent to participate in the study.
- Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.
- EBL, determined when investigator is ready to have the Alma peel pack opened: Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500 ml EBL
- Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may continue concomitantly with and post Alma use, as long as such use does...
- EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened.
- Delivery at a gestational age \< 34 weeks.
- For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma.
- PPH that the investigator determines to require more aggressive treatment, including any of the following:
- hysterectomy;
- b-lynch suture;
- uterine artery embolization or ligation;
- hypogastric ligation.
- Known uterine anomaly.
- Ongoing intrauterine pregnancy.
- Placenta abnormality including any of the following:
- known placenta accreta;
- retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);
- retained placenta without easy manual removal.
- Known uterine rupture.
- Unresolved uterine inversion.
- Subject has undergone intrauterine balloon therapy or uterine packing or use of other negative pressure system(s) for tamponade treatment of this PPH prior to use of Alma.
- Current cervical cancer.
- Current purulent infection of vagina, cervix, uterus.
- Diagnosis of coagulopathy.
The study team makes the final eligibility decision.
Where it's taking place
- Brooklyn, New York, United States
- Jerusalem, Israel
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brooklyn, New York, United States; Jerusalem, Israel. 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.