Postpartum Hemorrhage
Conditions
Brief summary
This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage (PPH).
Interventions
DEVICECELOX™ PPH
Celox™ PPH is intended to be a physical haemostatic treatment for control and treatment of uterine postpartum hemorrhage (PPH) when conservative management is warranted.
Sponsors
Charite University, Berlin, Germany
Medtrade
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation * Female Adult subjects (\>18 years of age). * Diagnosis of PPH with suspected uterine atony placental bed bleeding, placenta accreta or previa within 24 hours after vaginal delivery. * Subjects with coagulation disorders can be included * Minimal Estimated Blood Loss (EBL), to be determined when investigator is ready to have the Celox™ PPH package opened. 500 ml of EBL for vaginal delivery or 1000 ml for caesarean section. * Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post the Celox™ PPH use. * Subjects with PPH of cervical or vaginal origin.
Exclusion criteria
Subjects who present with, uterine rupture or for any other conditions outside of atonic post-partum haemorrhage needing other interventional methods or surgery including uterine artery embolization (UAE). * Pregnancy or incomplete multiple pregnancy * Unresolved uterine inversion. * Current cervical cancer. * Current purulent infection of the vagina, cervix, uterus. * Planned c-section with closed cervix. * Patients requiring trans-abdominal insertion of Celox™ PPH.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH). | Successful haemostasis is defined as absence of additional surgical or non-surgical interventions after application of Celox PPH. It is expected that within 2-5 minutes of application, the bleeding will be controlled. | The rate of patients in whom bleeding is controlled successfully. |
Contacts
Primary ContactJune Gladman
Outcome results
None listed