Vacuum Device for Hemostasis in Obstetrics and Gynecology

NCT02816203 | Completed DMC

• 1 other identifier: 38RC15.060
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Postpartum Hemorrhage; Administration of Sulprostone; Vaginal Childbirth

Outcome Measures

Primary Outcomes (1)

• 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®.

  The primary outcome is composite and consists of 3 the following component outcomes: 1. Qualification of success or failure of the introduction of the suction cup in the uterine cavity 2. Qualification of success or failure to create negative pressure in the suction cup. The negative pressure is validated if vacuum is maintained for at least 30 seconds. 3. Qualification of success or failure of removing the suction cup in its entirety. The feasibility of using the suction cup will be validated if success is obtained for the 3 component outcomes.

  36 month

Secondary Outcomes (6)

• Evaluation of the ease of the placement of the suction cup by the clinician

  36 month

• 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.

  36 month

• Evaluation of the ease of removal of the suction cup by the clinician

  36 month

• Quantification of blood loss during delivery

  36 month

• Evaluation of the number of patients for whom invasive treatment is necessary in order to stop the bleeding

  36 month

Study Arms (1)

Primary Hemostatic Intra-Uterine suction cup

EXPERIMENTAL

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

Device: Hemostatic Intra-Uterine suction cup

Interventions

Hemostatic Intra-Uterine suction cup DEVICE

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

Primary Hemostatic Intra-Uterine suction cup

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator
• HEMOSQUID: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)