Post Partum HaemorrhageJADAValleNCT06843265
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 study of Post Partum Haemorrhage, run by Fundacion Clinica Valle del Lili.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Haemorrhage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Maria F Escobar, Gynecologist and Obstetrician contact
About this study
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
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.
- Conditions
- Post Partum Haemorrhage
- Being tested
- Vacuum- Induce Hemorrhage Control
- Keywords
- maternal mortality, Shock Index, care bundle
- Medical subject headings
- Postpartum Hemorrhage, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum- Induce Hemorrhage ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Pregnant women with stage II postpartum hemorrhage, after vaginal delivery, who have had the JADA device implemented and meet INVIMA's definition of use of the instrument: the JADA system is intended to provide control and treatment of abnormal postpartum uterine bleeding or postpartum hemorrhage when conservative management is warranted, attended in hospitals in the context of the Godfather Hospital Strategy in the department of Valle del Cauca. Receives: Device: Vacuum- Induce Hemorrhage Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding control
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
Measured: up to 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario del Valle Evaristo Garcia
- Responsible party
- Principal investigator, María Fernanda Escobar, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843265
- Sponsor's protocol ID
- 2024.271
- Acronym
- JADAValle
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the Colombian regulations request it, then it would be made
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06843265
- Acronym / sponsor ID
- JADAValle / 2024.271
- Conditions
- Post Partum Haemorrhage
- Keywords
- maternal mortality, Shock Index, care bundle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Collaborators
- Hospital Universitario del Valle Evaristo Garcia
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Vacuum- Induce Hemorrhage ControlPregnant women with stage II postpartum hemorrhage, after vaginal delivery, who have had the JADA device implemented and meet INVIMA's definition of use of the instrument: the JADA system is intended to provide control and treatment of abnormal postpartum uterine bleeding or postpartum hemorrhage when conservative management is warranted, attended in hospitals in the context of the Godfather Hospital Strategy in the department of Valle del Cauca. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Pregnant women over or equal to 18 years of age.
- Gestational age of pregnancy greater than 32 weeks of gestation.
- Pregnant with vaginal delivery.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum- Induce Hemorrhage ControlThe 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. | Device | Group 1 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Undecided. If the Colombian regulations request it, then it would be made
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria F Escobar, Gynecologist and Obstetrician contact
Questions about this trial
What is this clinical trial studying?
A study of Post Partum Haemorrhage, run by Fundacion Clinica Valle del Lili.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria F Escobar, Gynecologist and Obstetrician (+57 315 433 1584 ext. 3055, maria.escobar.vi@fvl.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding control (time frame: up to 42 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.