Actively Recruiting
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Led by KOKO Medical Inc. · Updated on 2026-05-13
72
Participants Needed
19
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult Female, 18 years of age or older at time of consent.
- Able to understand and provide informed consent.
- Diagnosed with abnormal postpartum uterine bleeding (500 - 999 ml vaginal birth) or postpartum hemorrhage (1000 - 1500 ml vaginal or cesarean birth) with suspected uterine atony within 24 hours after birth.
- Estimated blood loss (EBL) between 500 and 1500 ml for vaginal birth or 1000 and 1500 ml for cesarean birth at the time of device use.
- Failed first-line treatments of uterotonics and uterine massage to stop bleeding, with uterotonic use allowed alongside the device.
You will not qualify if you...
- Estimated blood loss greater than 1500 ml at device use.
- Delivery before 34 weeks gestation or uterus size less than 34 weeks if multiples.
- Cesarean birth with cervix less than 2.5 cm dilated before device use.
- Bleeding requiring more aggressive treatments such as hysterectomy, B-lynch suture, uterine artery embolization or ligation, or hypogastric ligation.
- Known uterine abnormalities or rupture.
- Ongoing intrauterine pregnancy.
- Placental abnormalities including placenta accreta, retained placenta with risk factors, or placenta not easily manually removed.
- Unresolved uterine inversion.
- Prior use of intrauterine balloon therapy, uterine packing, or other negative pressure systems for bleeding before using the KOKO device.
- Current cervical cancer.
- Active infection of the vagina, cervix, or uterus.
- Diagnosis of coagulopathy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Christiana Care
Newark, Delaware, United States, 19718
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
4
Indiana University School of Medicine, Dept. of OBGYN
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
6
Ochsner Baptist
New Orleans, Louisiana, United States, 70115
Withdrawn
7
LSU Heath Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71103
Actively Recruiting
8
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
Actively Recruiting
9
New York-Presbyterian Medical Group Queens
Flushing, New York, United States, 11355
Actively Recruiting
10
New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)
New York, New York, United States, 10032
Actively Recruiting
11
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
12
MetroHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
13
The Cleveland Clinic
Cleveland, Ohio, United States, 44111
Actively Recruiting
14
The Ohio State University
Columbus, Ohio, United States, 43210
Active, Not Recruiting
15
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
16
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
17
UT Health Houston
Houston, Texas, United States, 77030
Actively Recruiting
18
UT Health San Antonio
San Antonio, Texas, United States, 78229
Not Yet Recruiting
19
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
D
Darra Bigelow
CONTACT
G
Gabrielle Herrmann
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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