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Postpartum HemorrhageSERENENCT06452355

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

A study testing KOKO Device in people with Postpartum Hemorrhage and Immediate Postpartum Hemorrhage, run by KOKO Medical Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
KOKO Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
17 sitesUnited States
Study dates
29 Aug 2024to 29 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 20Show fewer
  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Alabama

    Birmingham, Alabama, 35233

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • MetroHealth

    Cleveland, Ohio, 44109

  • The Cleveland Clinic

    Cleveland, Ohio, 44111

  • The Ohio State University

    Columbus, Ohio, 43210

  • Duke University

    Durham, North Carolina, 27705

  • New York-Presbyterian Medical Group Queens

    Flushing, New York, 11355

  • Baylor College of Medicine

    Houston, Texas, 77030

  • UT Health Houston

    Houston, Texas, 77030

  • Indiana University School of Medicine, Dept. of OBGYN

    Indianapolis, Indiana, 46202

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • University of Kentucky

    Lexington, Kentucky, 40536

  • University of Miami

    Miami, Florida, 33136

  • New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)

    New York, New York, 10032

  • Christiana Care

    Newark, Delaware, 19718

  • University of Utah

    Salt Lake City, Utah, 84132

  • LSU Heath Sciences Center - Shreveport

    Shreveport, Louisiana, 71103

Other trials in United States

About this study

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

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.

Read the detailed description

This IDE study is designed to evaluate the effectiveness and safety of the KOKO™ device to treat primary abnormal postpartum uterine bleeding or hemorrhage. The study is literature controlled.

Being tested
KOKO Device
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KOKO DeviceDevice

    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.

Study groups in NCT06452355
Study groupRoleWhat they receive
InterventionExperimentalThe KOKO device will be administered to participants who are diagnosed with abnormal postpartum uterine bleeding or hemorrhage.
Receives: Device: KOKO Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging

    Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second line or surgical intervention to control abnormal postpartum uterine bleeding or hemorrhage after the use of the KOKO device.

    Measured: 24 Hrs

  2. Safety: Incidence, Severity and Seriousness of Device-related Adverse Events Experienced by Participants.

    Incidence (i.e., rate or number of participants), severity and seriousness of device-related Adverse Events experienced by participants will be documented during the course of the study.

    Measured: 6 weeks

Secondary outcomes (4)

  1. Time to control abnormal postpartum uterine bleeding or hemorrhage

    Time from start of treatment to control of bleeding per protocol

    Measured: 24 Hrs

  2. Rate of non-surgical or surgical procedures after KOKO use

    Rate of non-surgical or surgical procedures required to control abnormal postpartum uterine bleeding or hemorrhage after KOKO use

    Measured: 24 Hrs

  3. Transfusion rate and units

    Rate of blood product transfusion required after KOKO use, and number of transfusions units administered

    Measured: 24 Hrs through discharge

  4. KOKO Device Usability

    Clinician reported assessment of KOKO device usability

    Measured: 24 Hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start29 Aug 2024
  3. Primary completion29 Jul 2026
  4. Study completion29 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase A is considered a Pilot Study during which 20 subjects were enrolled. Phase B will enroll up to 52 additional subjects.
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452355
Sponsor's protocol ID
KOKO-PPH-001 (PSD-10212)
Acronym
SERENE
Status last verified
Aug 2026
First submitted
5 Jun 2024
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 19385460

  • 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.

    PubMed 25103301

  • 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.

    PubMed 18819848

  • McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011 Aug;9(8):1441-51. doi: 10.1111/j.1538-7836.2011.04398.x.

    PubMed 21668737

  • AbouZahr C. Global burden of maternal death and disability. Br Med Bull. 2003;67:1-11. doi: 10.1093/bmb/ldg015.

    PubMed 14711750

  • 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.

    PubMed 21846436

  • 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.

    PubMed 20237047

  • 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.

    PubMed 32909970

  • 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.

    PubMed 31917139

Questions about this trial

What is this clinical trial studying?

A study testing KOKO Device in people with Postpartum Hemorrhage and Immediate Postpartum Hemorrhage, run by KOKO Medical Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging (time frame: 24 Hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06452355, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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