Post Partum Hemorrhage
Conditions
Keywords
Post Partum Hemorrhage
Brief summary
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.
Interventions
DEVICEInPress Device
Treatment with InPress Device for Postpartum Hemorrhage
Sponsors
Alydia Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Related SAE | 6 weeks | Number of device related SAEs |
| Number of Participants With Damage to Cervix, Uterus or Vagina | During the procedure | Number of any observable damage to cervix, uterus, vagina |
| Number of Participants With Uterine Inversion or Folding | During the procedure | Number of uterine inversion or folding during procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Uterine Contraction | During the procedure | 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. |
| Time | During the procedure | Time from insertion to removal of the device |
| Number of Participants With User Feedback on Placement of InPress | During the procedure | Positive user feedback on placement transvaginally |
| Number of Participants With User Feedback on Connection to Vacuum | During the procedure | Positive user feedback on connection to vacuum and maintenance of desired negative pressure |
Countries
Indonesia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| InPress Treatment with InPress Device for Postpartum Hemorrhage
InPress Device: Treatment with InPress Device for Postpartum Hemorrhage | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | InPress | — |
|---|---|---|
| Age, Continuous | 25.2 years STANDARD_DEVIATION 6.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Indonesia | 10 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Participants With Damage to Cervix, Uterus or Vagina
Number of any observable damage to cervix, uterus, vagina
Time frame: During the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InPress | Number of Participants With Damage to Cervix, Uterus or Vagina | 0 participants |
Primary
Number of Participants With Uterine Inversion or Folding
Number of uterine inversion or folding during procedure
Time frame: During the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InPress | Number of Participants With Uterine Inversion or Folding | 0 participants |
Primary
Number of Related SAE
Number of device related SAEs
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InPress | Number of Related SAE | 0 SAEs |
Secondary
Number of Participants With User Feedback on Connection to Vacuum
Positive user feedback on connection to vacuum and maintenance of desired negative pressure
Time frame: During the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InPress | Number of Participants With User Feedback on Connection to Vacuum | 9 participants |
Secondary
Number of Participants With User Feedback on Placement of InPress
Positive user feedback on placement transvaginally
Time frame: During the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InPress | Number of Participants With User Feedback on Placement of InPress | 10 participants |
Secondary
Time
Time from insertion to removal of the device
Time frame: During the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InPress | Time | 152 minutes | Standard Deviation 111.7 |
Secondary
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.
Time frame: During the procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| InPress | Time to Uterine Contraction | 1-2 minutes | 1 Participants |
| InPress | Time to Uterine Contraction | Less than 2 minutes | 9 Participants |