Hemorrhage, Postpartum, Immediate Postpartum Hemorrhage, Postpartum Hemorrhage
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICEKOKO Device
The intrauterine drain is extended into the uterus, where low pressure vacuum is applied to the uterus through the fabric intrauterine drain. The KOKO™ device utilizes this vacuum to remove excess blood and compress the uterus reducing further blood loss.
Sponsors
KOKO Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase A is considered a Pilot Study during which 20 subjects were enrolled. Phase B will enroll up to 52 additional subjects.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult Female, 18 years of age or older at time of consent. * Subject is able to understand and provide informed consent to participate in the study. * Diagnosis of abnormal postpartum uterine bleeding (500 - 999 ml for vaginal birth) or postpartum hemorrhage (1000 - 1500 ml for vaginal or Cesarean birth) with suspected atony within 24 hours after vaginal or cesarean birth. * EBL, to be determined when investigator is ready to have the KOKO packaging opened: Vaginal birth: 500 - 1500 ml EBL or Cesarean birth: 1000 - 1500 ml EBL. * Failed first - line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may continue concomitant with and post KOKO use.
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: 1. hysterectomy; 2. B-lynch suture; 3. uterine artery embolization or ligation; 4. hypogastric ligation. * Known uterine anomaly. * Ongoing intrauterine pregnancy. * Placental abnormality including any of the following: 1. known placenta accreta; 2. retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior cesarean and placenta previa); 3. retained placenta without easy manual removal. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging | 24 Hrs | Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second line or surgical intervention to control abnormal postpartum uterine bleeding or hemorrhage after the use of the KOKO device. |
| Safety: Incidence, Severity and Seriousness of Device-related Adverse Events Experienced by Participants. | 6 weeks | Incidence (i.e., rate or number of participants), severity and seriousness of device-related Adverse Events experienced by participants will be documented during the course of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to control abnormal postpartum uterine bleeding or hemorrhage | 24 Hrs | Time from start of treatment to control of bleeding per protocol |
| Rate of non-surgical or surgical procedures after KOKO use | 24 Hrs | Rate of non-surgical or surgical procedures required to control abnormal postpartum uterine bleeding or hemorrhage after KOKO use |
| Transfusion rate and units | 24 Hrs through discharge | Rate of blood product transfusion required after KOKO use, and number of transfusions units administered |
| KOKO Device Usability | 24 Hrs | Clinician reported assessment of KOKO device usability |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDena Goffman, MD
Columbia University
PRINCIPAL_INVESTIGATORBrian Iriye, MD
Sunrise Hospital
Outcome results
None listed