Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage

Running, not enrolling · Not applicable

Conditions studied: Postpartum Hemorrhage, Immediate Postpartum Hemorrhage, Hemorrhage, Postpartum

In brief

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.

Key facts

Study ID: NCT06452355
Run by: KOKO Medical Inc.
People needed: 72
Starts: 2024-08-29
Expected to finish: 2026-09-01
Last updated by the study team: 2026-07-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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:
hysterectomy;
B-lynch suture;
uterine artery embolization or ligation;
hypogastric ligation.
Known uterine anomaly.
Ongoing intrauterine pregnancy.
Placental abnormality including any of the following:
known placenta accreta;
retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior cesarean and placenta previa);
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.

Where it is running

University of Alabama — Birmingham, Alabama, United States
Christiana Care — Newark, Delaware, United States
University of Miami — Miami, Florida, United States
Indiana University School of Medicine, Dept. of OBGYN — Indianapolis, Indiana, United States
University of Kentucky — Lexington, Kentucky, United States
LSU Heath Sciences Center - Shreveport — Shreveport, Louisiana, United States
Sunrise Hospital and Medical Center — Las Vegas, Nevada, United States
New York-Presbyterian Medical Group Queens — Flushing, New York, United States
New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC) — New York, New York, United States
Duke University — Durham, North Carolina, United States
MetroHealth — Cleveland, Ohio, United States
The Cleveland Clinic — Cleveland, Ohio, United States
The Ohio State University — Columbus, Ohio, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Baylor College of Medicine — Houston, Texas, United States
UT Health Houston — Houston, Texas, United States
University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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