Clinical trial NCT06843265: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Partum Haemorrhage
Keywords: maternal mortality
Shock Index
care bundle
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
Collaborators: name: Hospital Universitario del Valle Evaristo Garcia
First posted: 2025-02-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Bleeding control
timeFrame: up to 42 days postpartum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: