Celoxâ„¢ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage (NCT06033170) | Clinical Trial Compass
UnknownNot Applicable
Celoxâ„¢ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
96 participantsStarted 2023-09
Plain-language summary
This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celoxâ„¢ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage (PPH).
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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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 Celoxâ„¢ 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 Celoxâ„¢ 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 Celoxâ„¢ PPH.
What they're measuring
1
Celoxâ„¢ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH).
Timeframe: 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.