Primary Postpartum HemorrhageHEMOGYN2NCT02816203
Vacuum Device for Hemostasis in Obstetrics and Gynecology
A study testing Hemostatic Intra-Uterine suction cup in people with Primary Postpartum Hemorrhage and Administration of Sulprostone, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Primary Postpartum Hemorrhage, Administration of Sulprostone, Vaginal Childbirth
- What is being tested?
- Hemostatic Intra-Uterine suction cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- person hospitalized without their consent
- person under legal protection
- person hospitalized for psychiatric care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage
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.
Read more
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.
Read the 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.
- Being tested
- Hemostatic Intra-Uterine suction cup
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic Intra-Uterine suction cupDevice
The hemostatic intra-uterine suction cup is introduced to the uterine cavity and a negative pressure is applied into the device.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Hemostatic Intra-Uterine suction cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Qualification of success or failure of the introduction of the suction cup in the uterine cavity
- 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.
- 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.
Measured: 36 month
Secondary outcomes (6)
Evaluation of the ease of the placement of the suction cup by the clinician
Visual quantitative satisfaction scale
Measured: 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.
Subjective evaluation of whether bleeding stops by the clinician after each time the suction cup is put under vacuum.
Measured: 36 month
Evaluation of the ease of removal of the suction cup by the clinician
Visual quantitative satisfaction scale
Measured: 36 month
Quantification of blood loss during delivery
Volume of blood collected in the container of the pump and in the collection bag from the beginning of the delivery until the removal of the suction cup
Measured: 36 month
Evaluation of the number of patients for whom invasive treatment is necessary in order to stop the bleeding
Number of patients for whom embolization or surgery is indicated
Measured: 36 month
Assessment of the duration of time required to place and remove the suction cup
Time duration for the placement and removal of the suction cup
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, HEMOSQUID
- Responsible party
- Sponsor
- Investigators
- Véronique Equy, MD, Principal investigator, Clinic of Gynecology and Obstetrics, University Hospital Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816203
- Sponsor's protocol ID
- 38RC15.060
- Acronym
- HEMOGYN2
- Status last verified
- Mar 2023
- First submitted
- 24 Jun 2016
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT02816203
- Acronym / sponsor ID
- HEMOGYN2 / 38RC15.060
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, HEMOSQUID
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Hemostatic Intra-Uterine suction cup | Experimental | Device: Hemostatic Intra-Uterine suction cupPatients who present primary postpartum hemorrhage requiring administration of Nalador and the suction cup placed in the uterine cavity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemostatic Intra-Uterine suction cupThe hemostatic intra-uterine suction cup is introduced to the uterine cavity and a negative pressure is applied into the device. | Device | Primary Hemostatic Intra-Uterine suction cup |
Primary outcome
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®.
Time frame: 36 month
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.
6 secondary outcomes
Evaluation of the ease of the placement of the suction cup by the clinician
Time frame: 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.
Time frame: 36 month
Evaluation of the ease of removal of the suction cup by the clinician
Time frame: 36 month
Quantification of blood loss during delivery
Time frame: 36 month
Evaluation of the number of patients for whom invasive treatment is necessary in order to stop the bleeding
Time frame: 36 month
Assessment of the duration of time required to place and remove the suction cup
Time frame: 36 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique Equy, MD principal investigator
Clinic of Gynecology and Obstetrics, University Hospital Grenoble, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostatic Intra-Uterine suction cup in people with Primary Postpartum Hemorrhage and Administration of Sulprostone, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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®. (time frame: 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.