Vacuum Device for Hemostasis in Obstetrics and Gynecology (HEMOGYN2)
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|ClinicalTrials.gov Identifier: NCT02816203|
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : March 18, 2020
Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of 500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours after delivery.
In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. After obstetric maneuvers therapeutic, options begin with uterotonic treatments before considering invasive treatments such as embolization, vessel ligation and hysterectomy. However, the morbidity associated with these techniques and the desire to preserve fertility mean that new therapeutic solutions have been conceived, which has recently led to the development of an innovative intrauterine hemostasis medical device : a hemostatic intrauterine suction cup.
Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this biomedical research, the study of a new medical device. Our hypothesis is that the uterine walls will append to the walls of the suction cup after the latter is put under vacuum. The actuation of the suction cup will lead to the aspiration of all sides of the uterus.
Considering that postpartum haemorrhage is an emergency situation where vital prognosis of the patient is engaged, we selected to collect the consent of the patient using an emergengy procedure.
|Condition or disease||Intervention/treatment||Phase|
|Primary Postpartum Hemorrhage Administration of Sulprostone Vaginal Childbirth||Device: Hemostatic Intra-Uterine suction cup||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Primary Hemostatic Intra-Uterine suction cup
Patients who present primary postpartum hemorrhage requiring administration of Nalador and the suction cup placed in the uterine cavity
Device: Hemostatic Intra-Uterine suction cup
The hemostatic intra-uterine suction cup is introduced to the uterine cavity and a negative pressure is applied into the device.
- Evaluation of the feasibility of using the hemostatic intrauterine suction cup in patients who present primary PPH (blood loss ≥ 500ml) after a vaginal childbirth requiring the administration of Nalador®. [ Time Frame: 36 month ]
The primary outcome is composite and consists of 3 the following component outcomes:
- Qualification of success or failure of the introduction of the suction cup in the uterine cavity
- Qualification of success or failure to create negative pressure in the suction cup. The negative pressure is validated if vacuum is maintained for at least 30 seconds.
- Qualification of success or failure of removing the suction cup in its entirety.
The feasibility of using the suction cup will be validated if success is obtained for the 3 component outcomes.
- Evaluation of the ease of the placement of the suction cup by the clinician [ Time Frame: 36 month ]Visual quantitative satisfaction scale
- Evaluation of whether the bleeding stops after each time the suction cup is put under vacuum. For each patient, the cup may be put once or twice under vacuum. [ Time Frame: 36 month ]Subjective evaluation of whether bleeding stops by the clinician after each time the suction cup is put under vacuum.
- Evaluation of the ease of removal of the suction cup by the clinician [ Time Frame: 36 month ]Visual quantitative satisfaction scale
- Quantification of blood loss during delivery [ Time Frame: 36 month ]Volume of blood collected in the container of the pump and in the collection bag from the beginning of the delivery until the removal of the suction cup
- Evaluation of the number of patients for whom invasive treatment is necessary in order to stop the bleeding [ Time Frame: 36 month ]Number of patients for whom embolization or surgery is indicated
- Assessment of the duration of time required to place and remove the suction cup [ Time Frame: 36 month ]Time duration for the placement and removal of the suction cup
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816203
|Contact: Véronique Equy, MD||+33 476 765 400||VEquy@chu-grenoble.fr|
|Contact: Emilie Chipon, PhD||+33 476 767 firstname.lastname@example.org|
|University Hospital Grenoble||Recruiting|
|Grenoble, France, 38043|
|Contact: Véronique Equy, MD +33 476 765 400 VEquy@chu-grenoble.fr|
|Contact: Isabelle Boudry, PhD +33 476 766 645 email@example.com|
|Sub-Investigator: Coston Anne-Laure, MD|
|Sub-Investigator: Dunand-Faure Camille, MD|
|Sub-Investigator: Gueniffey Aurore, MD|
|Sub-Investigator: Guigue Virginie, MD|
|Sub-Investigator: Hoffmann Pascale, MD|
|Sub-Investigator: Istasse François, MD|
|Sub-Investigator: Michy Thierry, MD|
|Sub-Investigator: Philippe Anne-Cécile, MD|
|Sub-Investigator: Gobillot Sophie, MD|
|Sub-Investigator: Thong-Vanh Catherine, MD|
|Principal Investigator:||Véronique Equy, MD||Clinic of Gynecology and Obstetrics, University Hospital Grenoble, France|