An interventional study of Vacuum- Induce Hemorrhage Control in Post Partum Haemorrhage, sponsored by Fundacion Clinica Valle del Lili. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Fundacion Clinica Valle del Lili · Not applicable, Interventional, and Treatment
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.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 24 is below the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Fundacion Clinica Valle del Lili is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
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Criteria for the use of JADA device:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 vacuum source and prevents clogging of the vacuum pores with tissue or clot.
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
Time frame: up to 42 days postpartum
No study locations are listed for this record.
Plan to share: Undecided — If the Colombian regulations request it, then it would be made
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Dec 2025, 6 months later.
Of 112 non-industry interventional studies with no phase under Postpartum Hemorrhage, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 6 months is below that.
Counting every sponsor, half of 119 studies reached it within 16 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Fundacion Clinica Valle del Lili