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

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.

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Key information

Conditions

Post Partum Haemorrhage Death Female Urogenital Diseases and Pregnancy Complications Hemorrhage Maternal Death Obstetric Labor Complications Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vacuum- Induce Hemorrhage Control

Device

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 vacuum source and prevents clogging of the vacuum pores with tissue or clot.

Primary outcomes

Bleeding control

Time frame: up to 42 days postpartum

Postpartum hemorrhage defined as quantified bleeding of more than 500 ml for vaginal deliveries and more than 1000 ml for cesarean deliveries, occurring within the first 24 h after delivery and which may be associated with signs of hemodynamic instability, i.e. the ratio between heart rate and systolic blood pressure (shock index).

Following this concept of the shock index and the amount of bleeding, the stages of postpartum hemorrhage are divided, which, according to the result of the shock index, the therapy is directed:

Stage 1: Bleeding 500-1000 cc, Shock index of <0.9, bleeding time <10 minutes. Stage 2: Bleeding 1000-1500 cc, shock index 0.9-1.4 bleeding time 10-20 minutes.

Stage 3: Bleeding <1500 cc, shock index >1.5, bleeding time greater than 20 minutes.

Stage 4: Cardiovascular collapse with profound hypovolemic shock and coagulopathy.

These stages will be measured through a bag which will fulfill the function of measuring to indicate the stage and amount of bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Maria F Escobar, Gynecologist and Obstetrician

CONTACT

[email protected]

+57 315 433 1584 ext. 3055

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Collaborators

Hospital Universitario del Valle Evaristo Garcia

Registry information

Official study 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

Acronym: JADAValle

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 24, 2025
Registry last updated: Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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