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

NCT01589744 | Terminated DMC

• 1 other identifier: DCIC 11 24
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

No Placental Abruption; No Hemorrhage

Keywords

medical device

Outcome Measures

Primary Outcomes (1)

• 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.

  18 month

Secondary Outcomes (3)

• Number of participants for which the setting up of the suction cup in uterus is a successful.

  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®.

  18 month

• Number of participants for which the withdrawal of the suction cup from the uterus is a successful.

  18 month

Study Arms (1)

Suction cup Hemostatic Intra-Uterin

EXPERIMENTAL

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)

Interventions

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

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.

Suction cup Hemostatic Intra-Uterin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AdministrateurCIC: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, France

Location

Related Links

• Related Info

Study Officials

• Véronique Equy, MD

  Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: May 2, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

FR (1)