Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Hemorrhage

April 3, 2024 updated by: Cemre Alan, Necmettin Erbakan University

Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Atony

This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony.

Study Overview

Status

Completed

Conditions

Detailed Description

A retrospective study of all women received Acar's uterine compressive atony suture between January 2021-November 2023 at a single tertiary hospital with approximately 4000 deliveries per year, was performed. The local protocol for PPH due to uterine atony is uterine manual compression, 20 IU of intravenous oxytocin in 500 cc of normal saline at 500 cc/h; 800 µg of misoprostol inserted per rectal. If additional treatment is needed, carbetocin 100mcg in 100 cc of normal saline or tranexamic acid in different posologies are used.

If uterine atony persists, intrauterine balloon tamponade or uterine compressive sutures were applied at the discretion of the physician and according to mode of delivery. When uterine compressive suture was performed, original Acar's atony suture was applied.

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Cemre Alan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women admitted to the university hospital for delivery and women referred to the university hospital with uterine atony diagnosis

Description

Inclusion Criteria:

  • women without systemic disease

Exclusion Criteria:

  • cardiac disease
  • rheumatological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
study group
The patients who had uterine atony during delivery and to whom Acar's atony suture were performed consisted study group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum hysterectomy and/or intensive care unit need ratio
Time Frame: Since first operation to discharge from hospital assessed up to 5 days
The need for hysterectomy or massive transfusion because of unstoppable and mortal bleeding
Since first operation to discharge from hospital assessed up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Investigators

  • Principal Investigator: Ali Acar, Clinic Prof., Necmettin Erbakan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1335cemre.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make IPD available. Because the investigators want to see long term results first and larger sample sizes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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