Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
NCT ID: NCT06452355
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2024-08-29
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
The KOKO device will be administered to participants who are diagnosed with abnormal postpartum uterine bleeding or hemorrhage.
KOKO Device
The intrauterine drain is extended into the uterus, where low pressure vacuum is applied to the uterus through the fabric intrauterine drain. The KOKO™ device utilizes this vacuum to remove excess blood and compress the uterus reducing further blood loss.
Interventions
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KOKO Device
The intrauterine drain is extended into the uterus, where low pressure vacuum is applied to the uterus through the fabric intrauterine drain. The KOKO™ device utilizes this vacuum to remove excess blood and compress the uterus reducing further blood loss.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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KOKO Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dena Goffman, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Brian Iriye, MD
Role: PRINCIPAL_INVESTIGATOR
Sunrise Hospital
Locations
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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
Ochsner Baptist
New Orleans, Louisiana, 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
UT Health San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Nancy Saxon
Role: primary
Carrie Kitto
Role: primary
Caroline Torres
Role: primary
Tamra Bryant, MD
Role: primary
Cynthia Cockerham
Role: primary
Jessica Paul
Role: primary
Michelle Crawford
Role: primary
Tina Dardac
Role: primary
Casandra Almonte
Role: primary
Kristin Weaver
Role: primary
Brittany DeSantis
Role: primary
Luann Polito
Role: primary
Taryn Summerfield, MS
Role: primary
Jesslyn Payne
Role: primary
Sarah Tounsi, MD
Role: primary
Sunbola Ashimi, PhD
Role: primary
Sally Kabro
Role: primary
Emily Powers
Role: primary
References
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Naz H, Sarwar I, Fawad A, Nisa AU. Maternal morbidity and mortality due to primary PPH--experience at Ayub Teaching Hospital Abbottabad. J Ayub Med Coll Abbottabad. 2008 Apr-Jun;20(2):59-65.
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25.
McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011 Aug;9(8):1441-51. doi: 10.1111/j.1538-7836.2011.04398.x.
AbouZahr C. Global burden of maternal death and disability. Br Med Bull. 2003;67:1-11. doi: 10.1093/bmb/ldg015.
Kramer MS, Dahhou M, Vallerand D, Liston R, Joseph KS. Risk factors for postpartum hemorrhage: can we explain the recent temporal increase? J Obstet Gynaecol Can. 2011 Aug;33(8):810-819. doi: 10.1016/S1701-2163(16)34984-2.
Bateman BT, Berman MF, Riley LE, Leffert LR. The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries. Anesth Analg. 2010 May 1;110(5):1368-73. doi: 10.1213/ANE.0b013e3181d74898. Epub 2010 Mar 17.
D'Alton ME, Rood KM, Smid MC, Simhan HN, Skupski DW, Subramaniam A, Gibson KS, Rosen T, Clark SM, Dudley D, Iqbal SN, Paglia MJ, Duzyj CM, Chien EK, Gibbins KJ, Wine KD, Bentum NAA, Kominiarek MA, Tuuli MG, Goffman D. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138.
Suarez S, Conde-Agudelo A, Borovac-Pinheiro A, Suarez-Rebling D, Eckardt M, Theron G, Burke TF. Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020 Apr;222(4):293.e1-293.e52. doi: 10.1016/j.ajog.2019.11.1287. Epub 2020 Jan 6.
Other Identifiers
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KOKO-PPH-001 (PSD-10212)
Identifier Type: -
Identifier Source: org_study_id