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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertility preservation	Number of cases in which it was not necessary to perform hysterectomy.	Within 24 hours after post-partum haemorrhage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood transfusions	Intraoperative transfusions (units).	Within 24 hours after post-partum haemorrhage
Subsequent pregnancies	Number of subsequent pregnancies (in case of successful management of Post-partum Haemorrhage)	120 months from the date of post-partum haemorrhage.

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: February 11, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Postpartum Hemorrhage; Hayman's Haemostatic Suture
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: HAYMAN-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No