MedTrace Logo

Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage

NCT05382403 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2023-12-21

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage
  • Maternal Death

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • University of Ghana

    collaborator OTHER

  • Kwame Nkrumah University of Science and Technology

    collaborator OTHER

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Methodius Tuuli, MD, MPH, MBA · Women and Infants Hospital of Rhode Island

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2026-08-31
Completion
2027-04-30
FDA Device
Yes

Countries

  • Ghana

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382403 on ClinicalTrials.gov