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

U

Università degli Studi dell'Insubria

Status

Unknown

Conditions

Postpartum Hemorrhage

Treatments

Procedure: Hayman's Haemostatic Suture

Study type

Observational

Funder types

Other

Identifiers

NCT03442491
HAYMAN-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • None.

Trial design

90 participants in 1 patient group

Hayman's Haemostatic Suture
Description:
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.
Treatment:
Procedure: Hayman's Haemostatic Suture

Trial contacts and locations

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Central trial contact

Antonio Simone Laganà, M.D.

Data sourced from clinicaltrials.gov

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