About this trial
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.
Eligibility criteria
Qualifiers
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.
Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.
Disqualifiers
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.
hysterectomy;
Trial design
Treatments tested in this trial
- Alma System