Maternal morbidity and mortality due to primary PPH--experience at Ayub Teaching Hospital Abbottabad.
Humaira Naz, Iram Sarwar, Anisa Fawad...
https://pubmed.ncbi.nlm.nih.gov/19385460Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID06452355
Clinical Trial to Assess Safety and Effectiveness of the KOKO™ Device for Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Led by KOKO Medical Inc. · Updated on 2026-05-29
72
Participants Needed
19
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the KOKO™ device in controlling and reducing primary abnormal postpartum uterine bleeding or hemorrhage. The study focuses on females 18 years or older who experience abnormal bleeding or hemorrhage shortly after vaginal or cesarean birth. It is an interventional study comparing outcomes based on current literature. Participants will receive the KOKO™ device, which uses an intrauterine drain with low pressure vacuum to remove excess blood and compress the uterus to reduce further blood loss. The device is applied within 24 hours after birth in cases where first-line treatments like uterotonics and uterine massage have failed. The study evaluates the device's use during the immediate postpartum period. During the study, researchers will monitor the rate of bleeding cessation within 24 hours and assess safety by tracking device-related adverse events up to six weeks. Additional measures include time to control bleeding, need for further surgical procedures, transfusion rates, and device usability. Participants are followed closely to evaluate both effectiveness and safety outcomes over the postpartum period.
CONDITIONS
Brief Title
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Who Can Participate
Age: 18Years +
FEMALE
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 for vaginal birth) or postpartum hemorrhage (1000 - 1500 ml for vaginal or cesarean birth) 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
- Failed first-line interventions including uterotonics and uterine massage to stop bleeding
You will not qualify if you...
- Estimated blood loss greater than 1500 ml
- Delivery before 34 weeks gestation or uterus size less than 34 weeks for multiples
- Cervix less than 2.5 cm dilated before KOKO device use in cesarean births
- Need for more aggressive treatment such as hysterectomy, B-lynch suture, uterine artery embolization or ligation, or hypogastric ligation
- Known uterine anomaly or rupture
- Ongoing intrauterine pregnancy
- Placental abnormalities including placenta accreta or retained placenta with risk factors
- Unresolved uterine inversion
- Prior use of intrauterine balloon therapy, uterine packing, or other negative pressure systems for this bleeding episode
- Current cervical cancer
- Current purulent infection of vagina, cervix, or uterus
- Diagnosis of coagulopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 24 hours
Participants diagnosed with abnormal postpartum uterine bleeding or hemorrhage receive the KOKO device treatment to reduce blood loss and control bleeding.
1 treatment visit (in-person)
Follow-up
Duration - Up to 6 weeks
Participants are monitored for safety and effectiveness of the KOKO device, including any device-related adverse events.
Approximately 3 to 4 follow-up visits (in-person or remote)
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
Active, Not 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
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Research Team
D
Darra Bigelow
G
Gabrielle Herrmann
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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Published Research Related To This Trial
Global causes of maternal death: a WHO systematic analysis.
Lale Say, Doris Chou, Alison Gemmill...
https://pubmed.ncbi.nlm.nih.gov/25103301Epidemiology of postpartum haemorrhage: a systematic review.
Guillermo Carroli, Cristina Cuesta, Edgardo Abalos...
https://pubmed.ncbi.nlm.nih.gov/18819848Obstetric hemorrhage.
C McLintock, A H James
https://pubmed.ncbi.nlm.nih.gov/21668737Global burden of maternal death and disability.
Carla AbouZahr
https://pubmed.ncbi.nlm.nih.gov/14711750Risk factors for postpartum hemorrhage: can we explain the recent temporal increase?
Michael S Kramer, Mourad Dahhou, Danielle Vallerand...
https://pubmed.ncbi.nlm.nih.gov/21846436The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries.
Brian T Bateman, Mitchell F Berman, Laura E Riley...
https://pubmed.ncbi.nlm.nih.gov/20237047Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.
Mary E D'Alton, Kara M Rood, Marcela C Smid...
https://pubmed.ncbi.nlm.nih.gov/32909970Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis.
Sebastian Suarez, Agustin Conde-Agudelo, Anderson Borovac-Pinheiro...
https://pubmed.ncbi.nlm.nih.gov/31917139