Clinical trial NCT02816203: Vacuum Device for Hemostasis in Obstetrics and Gynecology
Official title: Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Postpartum Hemorrhage
Administration of Sulprostone
Vaginal Childbirth
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: HEMOSQUID
First posted: 2016-06-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Evaluation of the feasibility of using the hemostatic intrauterine suction cup in patients who present primary PPH (blood loss ≥ 500ml) after a vaginal childbirth requiring the administration of Nalador®.
timeFrame: 36 month
Secondary outcomes:
measure: Evaluation of the ease of the placement of the suction cup by the clinician
timeFrame: 36 month
measure: Evaluation of whether the bleeding stops after each time the suction cup is put under vacuum. For each patient, the cup may be put once or twice under vacuum.
timeFrame: 36 month
measure: Evaluation of the ease of removal of the suction cup by the clinician
timeFrame: 36 month
measure: Quantification of blood loss during delivery
timeFrame: 36 month
measure: Evaluation of the number of patients for whom invasive treatment is necessary in order to stop the bleeding
timeFrame: 36 month
measure: Assessment of the duration of time required to place and remove the suction cup
timeFrame: 36 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: Clinic of Gynecology and Obstetrics, University Hospital Grenoble, France
name: Véronique Equy, MD
role: PRINCIPAL_INVESTIGATOR
References: