Vacuum Device for Hemostasis in Obstetrics and Gynecology

NCT ID: NCT02816203

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2022-12-31

Brief 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.

Detailed Description

In this study, as a first pass in human of this innovative non CE marked medical device, we aim to demonstrate the feasibility of using the hemostatic intrauterine suction cup for patients who present primary PPH (blood loss ≥ 500ml) after a vaginal delivery requiring administration of Nalador®. We will evaluate the placement of hemostatic suction cup in the uterus, the application of vacuum and its removal from the uterus.

Conditions

Primary Postpartum Hemorrhage; Administration of Sulprostone; Vaginal Childbirth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Primary Hemostatic Intra-Uterine suction cup

Patients who present primary postpartum hemorrhage requiring administration of Nalador and the suction cup placed in the uterine cavity

Group Type: EXPERIMENTAL

Hemostatic Intra-Uterine suction cup

Intervention Type: DEVICE

The hemostatic intra-uterine suction cup is introduced to the uterine cavity and a negative pressure is applied into the device.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• women between 18 and 45 years old
• patient under loco-regional anesthesia
• patient who presents primary postpartum hemorrhage (blood loss ≥ 500ml) after a vaginal childbirth requiring administration of Nalador®.
• affiliation to the French social security system or equivalent
• patient who has signed a consent to participate

Exclusion Criteria

• patient with a uterine malformation
• patient allergic to silicon
• patient under general anesthesia
• patient who delivered via caesarean section
• patient 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role: collaborator

HEMOSQUID

UNKNOWN

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Véronique Equy, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic of Gynecology and Obstetrics, University Hospital Grenoble, France

Locations

University Hospital Grenoble

Grenoble, , France

Countries

France

Other Identifiers

38RC15.060

Identifier Type: -

Identifier Source: org_study_id