Post Partum HemorrhageNCT04364386
Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
A study testing InPress Device in people with Post Partum Hemorrhage, run by Alydia Health at 2 sites in Indonesia.
Trial summary
Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- InPress Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesIndonesia
- Study dates
- 27 Jul 2014to 1 Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
- Female adult subjects (>18 years of age)
- Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum >= 500 ml and according to the Investigator's judgment, require an intervention.
Who cannot join
- Subjects who do not provide informed consent to participate in the clinical investigation.
- Subjects who deliver at a uterus size < 34 weeks.
- Subjects who have lost greater than 1000 ml of blood.
- Subjects who have abnormal PT, PTT and INR
- Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Dr. Cipto Mangunkusumo Hospital
Jakarta
RSIA Budi Kemuliaan Hospital
Jakarta
About this study
Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).
Read the detailed description
10 subjects in first in woman trial with ethics committee oversight. Women who developed postpartum hemorrhage were treated with the InPress Device. The intent of treatment was to quickly reduce or stop blood flow by addressing the driving cause of hemorrhage: uterine atony.
The primary objective is to verify the safety of the InPress Device in humans, including: 1. Absence of SAEs related to the use of the InPress Device intra- and post-procedure. 2. Evaluate any observable damage of the uterus, cervix, or vagina due to the use of the InPress Device. 3. Evaluate occurrence of uterine inversion or folding during the use of the InPress Device.
The secondary objectives include evaluations of: 1. Ability to easily place the InPress Device transvaginally. 2. Ability to connect the InPress Device to vacuum and maintain desired negative pressure. 3. Ability of InPress Device to contract the uterus to a level that reduces or stops blood loss and avoids further surgical intervention. 4. Evaluate time from insertion and start negative pressure to visible reduction of blood loss.
- Conditions
- Post Partum Hemorrhage
- Being tested
- InPress Device
- Keywords
- Post Partum Hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InPress DeviceDevice
Treatment with InPress Device for Postpartum Hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| InPress | Experimental | Treatment with InPress Device for Postpartum Hemorrhage Receives: Device: InPress Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Related SAE
Number of device related SAEs
Measured: 6 weeks
Number of Participants With Damage to Cervix, Uterus or Vagina
Number of any observable damage to cervix, uterus, vagina
Measured: During the procedure
Number of Participants With Uterine Inversion or Folding
Number of uterine inversion or folding during procedure
Measured: During the procedure
Secondary outcomes (4)
Number of Participants With User Feedback on Placement of InPress
Positive user feedback on placement transvaginally
Measured: During the procedure
Number of Participants With User Feedback on Connection to Vacuum
Positive user feedback on connection to vacuum and maintenance of desired negative pressure
Measured: During the procedure
Time to Uterine Contraction
Time to uterine contraction to a level that reduces or stops blood flow. Duration is exactly between 1 and 2 minutes for 1 participant, while the available data only suggests that it was less than 2 minutes for the rest of the participants but the exact duration cannot be narrowed down to 1-2 minutes.
Measured: During the procedure
Time
Time from insertion to removal of the device
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start27 Jul 2014
- Primary completion11 Feb 2015
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alydia Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuditiya Purwosunu, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364386
- Sponsor's protocol ID
- P-001
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan.
Publications
Purwosunu Y, Sarkoen W, Arulkumaran S, Segnitz J. Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade. Obstet Gynecol. 2016 Jul;128(1):33-36. doi: 10.1097/AOG.0000000000001473.
PubMed 27275795
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT04364386
- Acronym / sponsor ID
- P-001
- Conditions
- Post Partum Hemorrhage
- Keywords
- Post Partum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alydia HealthIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2014 (actual)
- Primary completion
- 11 Feb 2015 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 30 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).
Detailed description
10 subjects in first in woman trial with ethics committee oversight. Women who developed postpartum hemorrhage were treated with the InPress Device. The intent of treatment was to quickly reduce or stop blood flow by addressing the driving cause of hemorrhage: uterine atony.
The primary objective is to verify the safety of the InPress Device in humans, including: 1. Absence of SAEs related to the use of the InPress Device intra- and post-procedure. 2. Evaluate any observable damage of the uterus, cervix, or vagina due to the use of the InPress Device. 3. Evaluate occurrence of uterine inversion or folding during the use of the InPress Device.
The secondary objectives include evaluations of: 1. Ability to easily place the InPress Device transvaginally. 2. Ability to connect the InPress Device to vacuum and maintain desired negative pressure. 3. Ability of InPress Device to contract the uterus to a level that reduces or stops blood loss and avoids further surgical intervention. 4. Evaluate time from insertion and start negative pressure to visible reduction of blood loss.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InPress | Experimental | Device: InPress DeviceTreatment with InPress Device for Postpartum Hemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
- Female adult subjects (>18 years of age)
- Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum >= 500 ml and according to the Investigator's judgment, require an intervention.
Key exclusion criteria (5 listed)
- Subjects who do not provide informed consent to participate in the clinical investigation.
- Subjects who deliver at a uterus size < 34 weeks.
- Subjects who have lost greater than 1000 ml of blood.
- Subjects who have abnormal PT, PTT and INR
- Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
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 |
|---|---|---|
| InPress DeviceTreatment with InPress Device for Postpartum Hemorrhage | Device | InPress |
Primary outcome
Number of Related SAE
Time frame: 6 weeks
Number of device related SAEs
Number of Participants With Damage to Cervix, Uterus or Vagina
Time frame: During the procedure
Number of any observable damage to cervix, uterus, vagina
Number of Participants With Uterine Inversion or Folding
Time frame: During the procedure
Number of uterine inversion or folding during procedure
4 secondary outcomes
Number of Participants With User Feedback on Placement of InPress
Time frame: During the procedure
Number of Participants With User Feedback on Connection to Vacuum
Time frame: During the procedure
Time to Uterine Contraction
Time frame: During the procedure
Time
Time frame: During the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27275795Purwosunu Y, Sarkoen W, Arulkumaran S, Segnitz J. Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade. Obstet Gynecol. 2016 Jul;128(1):33-36. doi: 10.1097/AOG.0000000000001473.
- Individual participant dataSharing planned: No. No plan.
Related trials for Post Partum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Yuditiya Purwosunu, MD principal investigator
Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InPress Device in people with Post Partum Hemorrhage, run by Alydia Health at 2 sites in Indonesia.
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 3 inclusion and 5 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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?
Yes. Results are posted in the registry (first posted 30 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Related SAE (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04364386, which also lists 1 linked publication.
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 19 Sep 2024.