Study Details
Testing SERENE-KOKO Device for People with Postpartum Hemorrhage
(IRB#: IRB_00181690)
Postpartum hemorrhage is a condition of excessive bleeding after a person gives birth. This study will test KOKO a device to treat people with this condition. This study wants to see if the device will help people with this condition and if it is safe. People in the study will have abnormal postpartum bleeding within 24 hours after giving birth, and the bleeding will not stop with the use of medication or massage. The KOKO device will then be placed in the uterus to control bleeding for at least 90 minutes. General information about the hospital stay will be collected, including medications that may affect bleeding. At about 6 weeks after giving birth, participants will attend a standard postpartum doctor visit exam.
- Female Only
- Over 18 years old
- Healthy Volunteers
- In Person
- Paid
Who can participate?
Gender: Female Only
Age: Over 18 years old
Volunteers: Healthy Volunteers
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Giving childbirth at the University of Utah hospital
- Diagnosis of abnormal postpartum hemorrhage bleeding
- Other ways to stop bleeding have failed, such as medication and massage
Exclusion Criteria
- Childbirth before 34 weeks of the due date
- Abnormal postpartum bleeding that requires more intense treatment such as a hysterectomy
- Abnormal placenta
- Uterine rupture
- Cervical cancer
Will I be paid for my time?
Yes
IRB#: IRB_00181690
PI: Marcela Smid
Department: OBSTETRICS AND GYNECOLOGY
Approval Date: 2024-09-18 06:00:00
Specialties: OB/Gyn, General
I am Interested