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

Postpartum Hemorrhage Clinical Trial

— HAYMAN-1  

Official title:

Efficacy of Hayman's Haemostatic Suture for the Treatment of Severe Post-partum Haemorrhage Resistant to Pharmacologic Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03442491
• Other study ID #: HAYMAN-1
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: September 2021
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: 3296279579
• Email: antoniosimone.lagana[@]asst-settelaghi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility preservation	Number of cases in which it was not necessary to perform hysterectomy.	Within 24 hours after post-partum haemorrhage
Secondary	Blood transfusions	Intraoperative transfusions (units).	Within 24 hours after post-partum haemorrhage
Secondary	Subsequent pregnancies	Number of subsequent pregnancies (in case of successful management of Post-partum Haemorrhage)	120 months from the date of post-partum haemorrhage.