Using the KOKO Device to Treat Severe Bleeding After Childbirth

Clinical Trial Designed to Assess the Safety and Effectiveness of the KOKO™ Device In Treating Primary Abnormal Postpartum Uterine Bleeding ("APUB") or Hemorrhage ("PPH")

This study is testing if the KOKO device can help women who have severe bleeding after childbirth when other treatments haven't worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: KOKO Medical Inc. (Industry-sponsored)
• Locations: 19 sites (Birmingham, Alabama and 18 other locations)
• Trial ID: NCT06452355 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the KOKO™ device in controlling and reducing abnormal postpartum uterine bleeding or hemorrhage. It is designed for adult females who experience significant bleeding after vaginal or cesarean births and have not responded to initial treatments. The study will assess the device's performance in a controlled setting, focusing on its ability to manage bleeding within 24 hours post-delivery.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 18 and older who have abnormal postpartum bleeding after childbirth and have not responded to first-line treatments.

Not a fit: Patients with excessive bleeding over 1500 ml or those who delivered before 34 weeks gestation may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a new, effective treatment option for women experiencing severe postpartum hemorrhage.

How similar studies have performed: Other studies have explored similar interventions for postpartum hemorrhage, but the KOKO device represents a novel approach in this context.

Eligibility criteria

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.

Where this trial is running

Birmingham, Alabama and 18 other locations

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• Ochsner Baptist — New Orleans, Louisiana, United States (Withdrawn)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

Study contacts

• Principal investigator: Dena Goffman, MD — Columbia University
• Study coordinator: Darra Bigelow

Conditions Postpartum Hemorrhage; Immediate Postpartum Hemorrhage; Hemorrhage, Postpartum