Health TrialsbyHealthPanel

Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage

ConditionsPostpartum HemorrhageMaternal Death
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorWomen and Infants Hospital of Rhode Island

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Delivery at 34 weeks or greater

Cumulative blood loss >1000ml within 24 hours after delivery

Uterine atony

Disqualifiers

Patient unwilling or unable to provide informed consent

Retained placenta or other known cause of postpartum hemorrhage

Placenta accreta spectrum

Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Jada® System

    Device

    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

    Other intervention

    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.

Treatment groups

424 Participants
are divided into 2 treatment groups
Group A: Jada® SystemExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maternal survival without surgical intervention

No maternal death postpartum up to 6 weeks and no use of surgical interventions

Time frame
Delivery to 6 weeks post-delivery

Secondary outcomes

1

Time from randomization to control of bleeding

Time from use of first line treatment to control of bleeding

Time frame
6 weeks postpartum
2

Concentration of postpartum hemoglobin

hemoglobin level postpartum

Time frame
Postpartum day 1
3

Change in hemoglobin concentration from labor admission to postpartum day 1

Hemoglobin change between labor admission and postpartum

Time frame
Postpartum day 1
4

Rate of maternal transfusion of blood or blood products postpartum

Transfusion of blood or blood products postpartum

Time frame
6 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women and Infants Hospital of Rhode Island

Lead sponsor

Washington University School of Medicine

Collaborator

University of Ghana

Collaborator

Kwame Nkrumah University of Science and Technology

Collaborator

Source ClinicalTrials.gov
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