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Hayman's Haemostatic Suture to Treat Severe Post-partum Haemorrhage (HAYMAN-1)

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ClinicalTrials.gov Identifier: NCT03442491
Recruitment Status : Not yet recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

Brief Summary:

Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage.

Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.


Condition or disease Intervention/treatment
Postpartum Hemorrhage Procedure: Hayman's Haemostatic Suture

Detailed Description:

Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage.

The Hayman suture offers the potential advantages that can be applied fast and easy, a key point in an emergency situation, and avoids having to perform a lower segment hysterotomy when post-partum haemorrhage follows a vaginal delivery, therefore minimising the trauma to the atonic bleeding uterus.

Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Efficacy of Hayman's Haemostatic Suture for the Treatment of Severe Post-partum Haemorrhage Resistant to Pharmacologic Therapy
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hayman's Haemostatic Suture
Women that had major Post-partum Haemorrhage, defined as postpartum blood loss in excess of 2000 ml, resistant to pharmacologic treatment and that underwent Hayman's Haemostatic Suture.
Procedure: Hayman's Haemostatic Suture
After the uterus is exteriorised, bimanual compression is applied to check whether this stopped the bleeding, before the suture is applied. A number 2 polyglactin suture on a straight needle is used to transfix the uterus from front to back, just above the reflection of the bladder, and is then tied above the fundus of the uterus, while an assistant applies bimanual compression.




Primary Outcome Measures :
  1. Fertility preservation [ Time Frame: Within 24 hours after post-partum haemorrhage ]
    Number of cases in which it was not necessary to perform hysterectomy.


Secondary Outcome Measures :
  1. Blood transfusions [ Time Frame: Within 24 hours after post-partum haemorrhage ]
    Intraoperative transfusions (units).

  2. Subsequent pregnancies [ Time Frame: 120 months from the date of post-partum haemorrhage. ]
    Number of subsequent pregnancies (in case of successful management of Post-partum Haemorrhage)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women that had major Post-partum Haemorrhage, resistant to pharmacologic therapy, treated with Hayman's Haemostatic Suture.
Criteria

Inclusion Criteria:

  • Women that had major Post-partum Haemorrhage, resistant to pharmacologic therapy, treated with Hayman's Haemostatic Suture.

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442491


Contacts
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Contact: Antonio Simone Laganà, M.D. 3296279579 ext +39 antoniosimone.lagana@asst-settelaghi.it

Sponsors and Collaborators
Università degli Studi dell'Insubria

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Responsible Party: Antonio Simone Laganà, Medical Doctor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03442491     History of Changes
Other Study ID Numbers: HAYMAN-1
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Postpartum Hemorrhage
Hayman's Haemostatic Suture

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Hemostatics
Coagulants