Hayman's Haemostatic Suture to Treat Severe Post-partum Haemorrhage

NCT ID: NCT03442491

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-02-01

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.

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.

Conditions

Postpartum Hemorrhage

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Hayman's Haemostatic Suture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Antonio Simone Laganà

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Antonio Simone Laganà, M.D.

Role: CONTACT

antoniosimone.lagana@asst-settelaghi.it

3296279579 ext. +39

Other Identifiers

HAYMAN-1

Identifier Type: -

Identifier Source: org_study_id