Clinical trial NCT06452355: Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
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")
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Hemorrhage
Immediate Postpartum Hemorrhage
Hemorrhage, Postpartum
Lead sponsor: KOKO Medical Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging
timeFrame: 24 Hrs
measure: Safety: Incidence, Severity and Seriousness of Device-related Adverse Events Experienced by Participants.
timeFrame: 6 weeks
Secondary outcomes:
measure: Time to control abnormal postpartum uterine bleeding or hemorrhage
timeFrame: 24 Hrs
measure: Rate of non-surgical or surgical procedures after KOKO use
timeFrame: 24 Hrs
measure: Transfusion rate and units
timeFrame: 24 Hrs through discharge
measure: KOKO Device Usability
timeFrame: 24 Hrs
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Indianapolis
country: United States
facility: Indiana University School of Medicine, Dept. of OBGYN
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Baptist
state: Louisiana
city: New York
country: United States
facility: New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)
state: New York
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Columbia University
name: Dena Goffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011 Aug;9(8):1441-51. doi: 10.1111/j.1538-7836.2011.04398.x.
citation: AbouZahr C. Global burden of maternal death and disability. Br Med Bull. 2003;67:1-11. doi: 10.1093/bmb/ldg015.
citation: 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.
citation: 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.
citation: 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.
citation: 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.