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Status unknownNCT03442491HAYMAN-1Updated Sep 30, 2021

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

An observational study in Postpartum Hemorrhage, sponsored by Università degli Studi dell'Insubria. Status unknown. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-09-30.

Sponsored by Università degli Studi dell'Insubria · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
90
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postpartum Hemorrhage

Keywords

  • Postpartum Hemorrhage
  • Hayman's Haemostatic Suture
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None.
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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.

05

What researchers measure

Primary outcomes

  1. Fertility preservation

    Number of cases in which it was not necessary to perform hysterectomy.

    Time frame: Within 24 hours after post-partum haemorrhage

Secondary outcomes

  1. Blood transfusions

    Intraoperative transfusions (units).

    Time frame: Within 24 hours after post-partum haemorrhage

  2. Subsequent pregnancies

    Number of subsequent pregnancies (in case of successful management of Post-partum Haemorrhage)

    Time frame: 120 months from the date of post-partum haemorrhage.

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03442491
Lead sponsor
Università degli Studi dell'Insubria
Responsible party
Antonio Simone Laganà (Medical Doctor, Università degli Studi dell'Insubria) — Principal investigator
First posted
Feb 22, 2018
Start date
Jun 1, 2022 (estimated)
Primary completion
Feb 1, 2023 (estimated)
Completion
Feb 1, 2024 (estimated)
Last update
Sep 30, 2021

Study contacts

Antonio Simone Laganà, M.D.
Contact
antoniosimone.lagana@asst-settelaghi.it
3296279579 ext. +39

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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