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

NCT01589744 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-10-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • AdministrateurCIC

    lead OTHER

Principal Investigators

  • Véronique Equy, MD · Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589744 on ClinicalTrials.gov