Outcomes and Perceptions of the Implementation of the JADA Device in a Stage II Postpartum Hemorrhage Management Protocol in Referral Hospitals of the Colombian Pacific Region

Official title

Outcomes and Perceptions of the Implementation of the JADA Device in a Stage II Postpartum Hemorrhage Management Protocol in Referral Hospitals of the Colombian Pacific Region: a Cohort Study

Overview

This study focuses on postpartum hemorrhage (PPH), a condition that stands out as the leading cause of global maternal mortality. Annually, about 14 million women experience PPH, resulting in approximately 70,000 deaths. This condition presents a higher risk in low- and middle-income countries (LMICs), particularly where access to quality care is limited. Recognizing the urgency of addressing this public health problem, the Colombian Ministry of Health and Social Protection has implemented the Maternal Mortality Reduction Acceleration Plan (PARE) to improve maternal mortality indicators and meet the Sustainable Development Goals (SDGs). The project will evaluate the results and perception of a new device in the management of stage II PPH in referral hospitals in the department of Valle del Cauca, integrated in the Hospital Padrino strategy. This initiative seeks not only to improve the understanding and treatment of PPH, but also to strengthen institutional capacities through education, creation of telecare networks and care services adapted to local needs.

Interventions

• Device Vacuum- Induce Hemorrhage Control
  The JADA System is designed for single use only and is composed of medical grade silicone. Its components include an intrauterine loop with protected vacuum pores, a cervical seal with a sealing valve for infusing saline and a vacuum connector port for applying suction. The intrauterine loop is located at the distal end of a tube and contains 20 protected vacuum pores oriented inward along the loop. This shielded design facilitates intracavitary suction by shielding maternal tissue from the vacu

Primary outcome measures

• Bleeding control [Time frame: up to 42 days postpartum]

Eligibility criteria

Inclusion criteria

• Pregnant women who are admitted to the obstetrics service scheduled for vaginal delivery in any of the participating hospitals: Fundación Valle del Lili, Hospital Universitario del Valle and Hospital Luis Ablanque de la Plata.
• Patient admitted during the shift of one of the gynecologists trained in the use of the JADA device in the context of the research project.

Criteria for the use of JADA device:

• Pregnant women over or equal to 18 years of age.
• Gestational age of pregnancy greater than 32 weeks of gestation.
• Pregnant with vaginal delivery.
• Pregnant with postpartum hemorrhage due to uterine atony that does not respond to treatment with uterotonics and uterine massage.
• Postpartum hemorrhage uterine stage/stage II.
• Vaginal delivery attended in a health institution in the context of the Hospital Padrino strategy (Fundación Valle del Lili or Hospital Universitario del Valle or Hospital Luis Ablanque de la Plata).

Exclusion criteria

• Patients who, according to the attending physician's criteria, are not candidates for vaginal delivery.
• Abnormality of the normal uterine anatomy.
• Placental abnormalities.
• Maternal anemia with hemoglobin less than 7 mg/dl prior to delivery.
• Those who do not sign informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06843265 · 2024.271

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗