Overview
Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours after vaginal birth or cesarean section.
In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth.
The purpose of this prospective, non-randomized, feasibility pilot study is to obtain information on the safety and effectiveness of an investigational new medical device - Alma System, that is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
Description
A prospective, non-randomized, feasibility pilot study that is intended to obtain information on the safety and effectiveness of the Alma System.
Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage.
The main questions are:
- Rate of device related SAEs up to six weeks following device treatment.
- Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure.
- Rate of occurrence of uterine inversion of folding during or immediately after device procedure.
Main tasks for participants:
- sign the informed Consent form and enrolment
- In case of PPH, treatment with Alma
- Participate in 2 follow-up visits After the treatment- 1st upon discharge and 2nd after 6 weeks.
Eligibility
Inclusion Criteria:
- Adult Female, 18 years of age or older at time of consent.
- Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
- Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum > = 500 ml and according to the Investigator's judgment, require an intervention.
- Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.
Exclusion Criteria:
- Subjects who do not provide informed consent to participate in the clinical investigation.
- Subjects who deliver at a uterus size < 34 weeks.
- Subjects who have lost greater than 1000 ml of blood.
- Subjects who have abnormal PT, PTT and INR
- Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
- 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.
- Placental 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.