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The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.
Full description
This IDE study is designed to evaluate the effectiveness and safety of the KOKO™ device to treat primary abnormal postpartum uterine bleeding or hemorrhage. The study is literature controlled.
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Inclusion criteria
Exclusion criteria
EBL >1500ml, to be determined when investigator is ready to have the KOKO packaging opened.
Delivery at a gestational age < 34 weeks or, if multiples, uterus is judged <34 weeks size.
For cesarean births: Cervix < 2.5 cm dilated before use of KOKO.
Abnormal postpartum uterine bleeding or hemorrhage that the investigator determines to require more aggressive treatment, including any of the following:
Known uterine anomaly.
Ongoing intrauterine pregnancy.
Placental abnormality including any of the following:
Known uterine rupture.
Unresolved uterine inversion.
Subject has undergone intrauterine balloon therapy, uterine packing or use of other negative pressure system(s) for tamponade treatment of this episode of abnormal postpartum uterine bleeding or hemorrhage prior to use of the KOKO™ device.
Current cervical cancer.
Current purulent infection of vagina, cervix, uterus.
Diagnosis of coagulopathy.
Primary purpose
Allocation
Interventional model
Masking
52 participants in 1 patient group
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Central trial contact
Cathy Unruh; Gabby Herrmann
Data sourced from clinicaltrials.gov
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