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Vacuum Device for Hemostasis in Obstetrics and Gynecology

NCT02816203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Primary Postpartum Hemorrhage
  • Administration of Sulprostone
  • Vaginal Childbirth

Interventions

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.

Sponsors & Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

    collaborator NETWORK

  • HEMOSQUID

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2022-12-31
Completion
2022-12-31

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 NCT02816203 on ClinicalTrials.gov