An interventional study of Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed) in No Placental Abruption and No Hemorrhage, sponsored by AdministrateurCIC. Terminated at 1 site in France. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-18.
Sponsored by AdministrateurCIC · Not applicable, Interventional, and Health services research
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The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus, examination of the birth canal), begins with uterotonic treatments for invasive treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these techniques and the desire to preserve fertility required to devise new therapeutic solutions, which have recently led to the development of an innovative medical device intrauterine hemostasis.
The postpartum haemorrhage are mainly the result of weak and bleeding from the surface corresponds to the placental insertion, which is no longer localized. With the innovative medical device, our main hypothesis is that the uterine walls will append to the walls of the cup after depressurization of the latter. The actuation of the suction cup will lead to aspiration of all sides of the uterus (it is mostly the anterior and posterior that are important). The suction cup is flexible to adapt to the size of the uterus in order to be placed and removed easily from the uterine cavity.
In this study, as a first pass in Human, innovative medical device not CE marked, we did not aim to show control of the bleeding stops in the case of PPH but to prove, in a clinical situation with no foreseeable risk to the volunteers included (volunteers who have given birth without placental abruption after 30 minutes despite the directed delivery), proof of concept of using this system in these women that creates a vacuum in the Intra uterine Haemostatic vacuum and thus a joining of the walls of the uterus. This first step seems essential in order to effectively implement this medical device with serenity in emergency situations of PPH.
23 studies on the registry are indexed under Abruptio Placentae; 4 are open to participants now.
This study's enrollment of 1 is below the median of 142 across 10 interventional studies indexed under Abruptio Placentae.
Browse Abruptio Placentae studies →AdministrateurCIC is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The suction haemostatic cup will be positioned into the uterus, and the aim is to stop haemorrhage
Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)
The haemostatic intra-uterine suction-cup is introduced in uterus and a depressure in this device is applied. This medical device is used for 5 minutes at maximum.
Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization.
Comparison of ultrasound images before and after depression in the suction cup. The joining of tissues on the suction cup is characterized by a better visualization of posterior structures following the depressurization by eliminating air in the haemostatic intra-uterine suction cup.
Time frame: 18 month
Number of participants for which the setting up of the suction cup in uterus is a successful.
Qualification of success or failure of the setting up and score between 0 and 10 on a Visual,quantitative satisfaction scale.
Time frame: 18 month
Number of participant for which there is a persistence of the joining walls of the uterus around the suction cup between 1 and 5 minutes at maximum after passage of the depression with Redon Drainobag®.
Time frame: 18 month
Number of participants for which the withdrawal of the suction cup from the uterus is a successful.
Qualification of success or failure of natural withdrawal of the suction cup and score between 0 and 10 on a visual, quantitative satisfaction scale.
Time frame: 18 month
The record gives a start of Jul 2012, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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AdministrateurCIC