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Completed

NCT Number: NCT04364386

Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage

Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

InPress Device

Device

Treatment with InPress Device for Postpartum Hemorrhage

Primary outcomes

  1. Number of Related SAE

    Time frame: 6 weeks

    Number of device related SAEs

  2. Number of Participants With Damage to Cervix, Uterus or Vagina

    Time frame: During the procedure

    Number of any observable damage to cervix, uterus, vagina

  3. Number of Participants With Uterine Inversion or Folding

    Time frame: During the procedure

    Number of uterine inversion or folding during procedure

Secondary outcomes

  1. Number of Participants With User Feedback on Placement of InPress

    Time frame: During the procedure

    Positive user feedback on placement transvaginally

  2. Number of Participants With User Feedback on Connection to Vacuum

    Time frame: During the procedure

    Positive user feedback on connection to vacuum and maintenance of desired negative pressure

  3. Time to Uterine Contraction

    Time frame: 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.

  4. Time

    Time frame: During the procedure

    Time from insertion to removal of the device

Sponsors and collaborators

Lead sponsor

Alydia Health

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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