Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
NCT ID: NCT05382403
Last Updated: 2023-12-21
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
424 participants
INTERVENTIONAL
2023-10-23
2027-04-30
Brief Summary
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Detailed Description
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Uterine balloon tamponade is often the second line therapy when medical management is unsuccessful and is achieved with inflatable devices inserted into the uterus to exert outward compression on the uterine walls. Despite its widespread use, its mechanism is counterintuitive to the physiologic uterine contraction that occurs after delivery to control bleeding. Its use is further limited by prolonged treatment times (typically 12-24 hours), urinary tract occlusion, and inability to reveal any continuing bleeding. Low-cost options most commonly condom catheters are used in LMICs, but two recent randomized trials showed no improvement in maternal outcomes and possible harm. Thus, there is an urgent need for effective and safe treatment options to reduce the burden of PPH particularly in LMICs.
The Jada® System (Alydia Health, Menlo Park, CA, USA) is a novel U.S. FDA-cleared intrauterine vacuum-induced hemorrhage-control device specifically designed for rapid treatment of PPH. It mimics postpartum physiology by applying low-level intrauterine negative pressure to facilitate uterine compressive forces for constriction of blood vessels to achieve hemostasis. Preliminary data from two studies have shown promising results. The device was first evaluated in a feasibility case series (n=10) in Indonesia and showed rapid treatment of abnormal postpartum uterine bleeding.6 The second larger study, a multicenter single-arm trial (n=106) in the United States, confirmed quick and definitive control of bleeding in 94% of cases within a median time of 3 minutes and few adverse events. While promising, these data are limited by lack of control groups, possible selection bias and the modest sample sizes which preclude definitive conclusions regarding the relative effectiveness and safety of the Jada® System.
We propose the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care. A multidisciplinary team of investigators with expertise in obstetrics, global health and clinical trials will enroll 424 women in two high volume obstetric units in Ghana, a LMIC with high PPH burden, to pursue the following specific aims:
Primary Aim: Evaluate the effectiveness of the Jada® System, compared to standard care, in treating PPH.
Secondary Aim 1: Assess the safety of the Jada® System, compared to standard care, in treating PPH.
Secondary Aim 2: Estimate the cost-effectiveness of the Jada® System, compared to standard care, in treating PPH.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Jada® System
Patients in this group will have the Jada® System applied when the initial medical treatment fails, and estimated blood loss reaches 1000 mL. It is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted.
Jada® System
This is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted. The device is made of medical grade silicone. The distal end, which is placed in the uterus, is an elliptical loop. The circular cervical seal, just outside the external cervical os, is filled with 60 - 120 mL sterile water. Low-level vacuum (80 ± 10 mm Hg) is applied and pooled blood is evacuated from the uterus as it collapses. Once there is no bleeding, the device remains in the uterus for at least 1 hour. The suction is then disconnected, the seal emptied of water, the device left in place, and the patient monitored for an additional 30 minutes. If bleeding remains controlled, the device is removed. If bleeding is uncontrolled with the Jada® System patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy.
Standard care
Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy
Standard care
Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy.
Interventions
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Jada® System
This is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted. The device is made of medical grade silicone. The distal end, which is placed in the uterus, is an elliptical loop. The circular cervical seal, just outside the external cervical os, is filled with 60 - 120 mL sterile water. Low-level vacuum (80 ± 10 mm Hg) is applied and pooled blood is evacuated from the uterus as it collapses. Once there is no bleeding, the device remains in the uterus for at least 1 hour. The suction is then disconnected, the seal emptied of water, the device left in place, and the patient monitored for an additional 30 minutes. If bleeding remains controlled, the device is removed. If bleeding is uncontrolled with the Jada® System patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy.
Standard care
Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy.
Eligibility Criteria
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Inclusion Criteria
* Delivery at 34 weeks or greater
* Cumulative blood loss \>1000ml within 24 hours after delivery
* Uterine atony
* Receipt of first-line uterotonics
* Cervix at least 3cm dilated at cesarean section
Exclusion Criteria
* Retained placenta or other known cause of postpartum hemorrhage
* Placenta accreta spectrum
* Coagulopathy
* Rupture uterus
* Surgical management immediately needed for life-threatening bleeding
* Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection
18 Years
44 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
University of Ghana
OTHER
Kwame Nkrumah University of Science and Technology
OTHER
Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
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Methodius Tuuli
Professor and Chair of Obstetrics and Gynecology
Principal Investigators
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Methodius Tuuli, MD, MPH, MBA
Role: PRINCIPAL_INVESTIGATOR
Women and Infants Hospital of Rhode Island
Locations
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Komfo Anokye Teaching Hospital
Kumasi, Ashanti Region, Ghana
Korle-bu Teaching Hospital
Accra, Greater Accra Region, Ghana
Countries
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Central Contacts
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Facility Contacts
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Edward Dassah, MBChB, PhD
Role: primary
Samuel Oppong, MBChB
Role: primary
Other Identifiers
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PACTR202204852865149
Identifier Type: -
Identifier Source: org_study_id