Proof of Concept Study of a Sucker Hemostatic Intra Uterine in Postpartum Hemorrhage After Abruptio Placenta Assisted (HEMOGYN)

AdministrateurCIC

Status: Terminated

Conditions: No Placental Abruption; No Hemorrhage

Treatments: Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)

Study type: Interventional

Funder types: Other

Identifiers

NCT01589744

DCIC 11 24

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• woman between 18 and 45 years old,
• affiliation to the French social security system or equivalent,
• volunteers signed a consent to participate,
• volunteer is under loco-regional anaesthesia,
• volunteer whose the placenta has not taken off after 30 minutes despite the directed delivery.

Exclusion criteria

• volunteer carries uterine malformations,
• volunteer with post-partum haemorrhage (blood loss> 500 ml),
• volunteer allergic to silicon,
• volunteer under general anaesthesia,
• pregnancy not unique,
• volunteer with fever or suspected infection during labor,
• Person deprived of freedom by judicial or administrative decision
• Person hospitalized without their consent
• Person under legal protection
• Person hospitalized for psychiatric care

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

Suction cup Hemostatic Intra-Uterin

Experimental group

Description:

The suction haemostatic cup will be positioned into the uterus, and the aim is to stop haemorrhage

Treatment:

Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)