Clinical Trial Designed to Assess the Safety and Effectiveness of the KOKO Device In Treating Primary Abnormal Postpartum Uterine Bleeding ("APUB") or Hemorrhage ("PPH")
C
Christina M. Scifres, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
Female
Phase
N/A
5 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
The sponsor of this research study, KOKO Medical Inc, is evaluating a medical device to control and treat abnormal postpartum uterine bleeding or hemorrhage (excessive bleeding). The device is called the KOKO device and its use in this study is experimental. 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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - This study will identify and enroll pregnant females who are about to give birth since excessive bleeding is a potential risk following delivery.
Detailed description of study
What will happen during the study?
- As part of the study, participants' vital signs will be assessed, and a small amount of blood may be taken. Blood may be tested to determine how quickly it can clot. Blood pressure, heart rate, respiratory rate and temperature will be taken.
- If diagnosed with abnormal postpartum uterine bleeding or hemorrhage within 24 hours after vaginal or c-section birth, and the bleeding has not resolved with the use of medication or massage, participants may be enrolled in this study.
- The KOKO device would be inserted into the uterus and connected to a vacuum that creates gentle suction. KOKO is intended to be left in place for at least 90 minutes. Information about the hospital stay will be collected, including use of medications that may affect bleeding and assessment of general health.
- At approximately 6 weeks following delivery, participants will return to their doctor’s office for standard of care postpartum visit. This will include a limited pelvic exam and additional questions about their general health and medication use.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Postpartum Uterine Bleeding, Postpartum Uterine Hemorrhage
-
Age: 18 years - 100 years
-
Gender: Female
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:
- 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.
Updated on
26 Mar 2025.
Study ID: OBGYN-KOKO-SERENE, 25498
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
