Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage (PEARLE)

Alydia Health

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Device: Jada System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02883673

CIP-01 v2.6

PPH-02 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.

Enrollment: 107 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult Female, 18 years of age or older at time of consent.
2. Able to understand and provide informed consent to participate in the study.
3. Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section delivery.
4. EBL, to be determined when investigator is ready to have Jada peel pack opened: a) vaginal delivery: 500 - 1500 ml EBL or b) c-section delivery: 1000 - 1500 ml EBL.
5. Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post Jada use.

Exclusion criteria

1. EBL > 1500 ml, to be determined when investigator is ready to have the Jada peel pack opened.
2. Delivery at a gestational age < 34 weeks.
3. For C-sections: Cervix < 3 cm dilated before Jada use.
4. PPH that the investigator determines to require more aggressive treatment, including any of the following: a) hysterectomy, b) b-lynch suture, c) uterine artery embolization or ligation, d) hypogastric ligation.
5. Known uterine anomaly.
6. Ongoing intrauterine pregnancy.
7. Placenta abnormality including any of the following: a) known placenta accreta, b) retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa), c) retained placenta without easy manual removal.
8. Known uterine rupture.
9. Unresolved uterine inversion.
10. Subject has undergone intrauterine balloon therapy or uterine packing for tamponade treatment of this PPH prior to use of the Jada.
11. Current cervical cancer.
12. Current purulent infection of the vagina, cervix, uterus.
13. Diagnosis of coagulopathy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Intervention

Experimental group

Description:

Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.

Treatment:

Device: Jada System