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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03442491
Acronym
HAYMAN-1
Enrollment
90
Registered
2018-02-22
Start date
2022-06-01
Completion date
2024-02-01
Last updated
2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

Postpartum Hemorrhage, Hayman's Haemostatic Suture

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.

Interventions

PROCEDUREHayman'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.

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
Fertility preservationWithin 24 hours after post-partum haemorrhageNumber of cases in which it was not necessary to perform hysterectomy.

Secondary

MeasureTime frameDescription
Blood transfusionsWithin 24 hours after post-partum haemorrhageIntraoperative transfusions (units).
Subsequent pregnancies120 months from the date of post-partum haemorrhage.Number of subsequent pregnancies (in case of successful management of Post-partum Haemorrhage)

Contacts

Primary ContactAntonio Simone Laganà, M.D.
antoniosimone.lagana@asst-settelaghi.it3296279579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026