Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
NOVIC
1 other identifier
interventional
424
1 country
2
Brief Summary
This will be 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
December 21, 2023
December 1, 2023
2.9 years
May 15, 2022
December 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Maternal survival without surgical intervention
No maternal death postpartum up to 6 weeks and no use of surgical interventions
Delivery to 6 weeks post-delivery
Secondary Outcomes (13)
Time from randomization to control of bleeding
6 weeks postpartum
Concentration of postpartum hemoglobin
Postpartum day 1
Change in hemoglobin concentration from labor admission to postpartum day 1
Postpartum day 1
Rate of maternal transfusion of blood or blood products postpartum
6 weeks postpartum
Number of units of blood products transfused
6 weeks postpartum
- +8 more secondary outcomes
Study Arms (2)
Jada® System
EXPERIMENTALPatients 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.
Standard care
ACTIVE COMPARATORPatients 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
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.
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
You may qualify if:
- years or older
- 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
You may not qualify if:
- Patient unwilling or unable to provide informed consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Women and Infants Hospital of Rhode Islandlead
- Washington University School of Medicinecollaborator
- University of Ghanacollaborator
- Kwame Nkrumah University of Science and Technologycollaborator
Study Sites (2)
Komfo Anokye Teaching Hospital
Kumasi, Ashanti Region, Ghana
Korle-bu Teaching Hospital
Accra, Greater Accra Region, Ghana
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Methodius Tuuli, MD, MPH, MBA
Women and Infants Hospital of Rhode Island
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair of Obstetrics and Gynecology
Study Record Dates
First Submitted
May 15, 2022
First Posted
May 19, 2022
Study Start
October 23, 2023
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
December 21, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 5 years after completion of trial.
- Access Criteria
- We will make the data and associated documentation available to users under a data-sharing agreement that provides for commitment to: a) using the data only for research purposes and not to identify any individual participant; b) securing the data using appropriate computer technology; and c) destroying or returning the data after analyses are completed. Timelines for distribution of data will vary depending on any required restrictions as mentioned above. Data may be distributed by a number of electronic methods, including web-based databases, datasets, and spreadsheets, or via electronic media such as compact discs.
Data will be collected from human subjects and will be shared according to NIH guidelines. We are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. We will make a complete study dataset available for sharing. We will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. We will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.