EVE TRIAL , ALMA SYSTAM

Conditions

• PPH
• Postpartum Haemorrhage (PPH)
• Postpartum Hemorrhage (Primary)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Alma System — DEVICE
  Subjects diagnosed with abnormal bleeding or postpartum hemorrhage will receive the Alma System. This system comprises a soft silicone cylindrical device placed within the uterus. Gentle suction is applied, prompting the uterus to contract and reduce in size. This contraction compresses the blood vessels, halting the bleeding.

Study Details

abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four cups) after a cesarean section. It is a serious and potentially life-threatening complication that requires immediate medical treatment. What you need to know: * Signing this form does not mean you will have an emergency postpartum bleeding. * We will only include you in the study IF abnormal bleeding happens after your birth. * If abnormal bleeding does happen, your doctors will first try the usual treatments that work in accordance with the hospital's PPH protocol. * The study device (called Alma system) would only be used if the usual treatments do not stop the bleeding. Treatment Schedule - Recruitment \& Consenting * Screening and enrolment. * Treatment of PPH with Alma system. * Alma Survey * Follow up examination post treatment procedure (after removal of Alma system and before subject discharge from the hospital). * 6-week postpartum follow-up examination.

Key Dates

Start date

Jan 11, 2026

Status verified

Mar 2026

Primary completion

Jan 31, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Participant group
  Woman who developed PPH after vaginal or caesarean delivery and first line interventions have been attempted and failed, and to which the Alma System was applied

Primary Outcome Measure

Incidence of safety events [ Time Frame: 6 weeks ]

Central Contacts

• Yael Corcos, RN
  972-548106010
  [email protected]

Locations (1)

Find similar trials in Brooklyn, NY