CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 107 enrolled
Drug / intervention
Jada Systemdevice
Likely dose
Jada System: soft silicone ring placed into uterus with gentle suction appliedAI-extracted
Key inclusion· 4
  • ✓Adult female, 18 years or older at time of consent
  • ✓Diagnosis of primary postpartum hemorrhage (PPH) with suspected atony within 24 hours after vaginal or cesarean delivery
  • ✓Estimated blood loss (EBL) between 500–1500 mL for vaginal delivery or 1000–1500 mL for cesarean delivery
  • ✓Failed first-line intervention of uterotonics and uterine massage or bimanual compression to stop bleeding
Key exclusion· 10
  • ✕Estimated blood loss (EBL) exceeds 1500 mL
  • ✕Delivery at gestational age less than 34 weeks
  • ✕For cesarean deliveries: cervix less than 3 cm dilated before Jada use
  • ✕PPH requiring more aggressive treatment such as hysterectomy, B-Lynch suture, uterine artery embolization or ligation, or hypogastric ligation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02883673
NCT02883673N/ACompleted
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Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

Alydia Health·interventional·Posted Aug 30, 2016·Updated Aug 22, 2022

In Brief

A clinical study evaluating Jada System for Postpartum Hemorrhage. Completed, enrolled 107 participants across 15 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Hemorrhage
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 30, 2016
Enrollment StartSep 17, 2017
Primary CompletionJan 26, 2020
Study CompletionMar 25, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.8 years ago

Interventions

Jada Systemdevice

It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.