Fibrinogen Concentrate and Placenta Acreta Spectrum

July 31, 2023 updated by: Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Is the Use of Fibrinogen in Cesarean Section Related to Bleeding and Blood Product in Patients With Placenta Accreta Spectrum?: a Retrospective Randomized Study

The aim of this study is to evaluate the relationship between fibrinogen use and bleeding in patients who underwent cesarean section with a prediagnosis of PAS.

The key question(s) it aims to answer are:

[Does the use of fibrinogen concentrate reduce bleeding in PAS patients?] Patients who had a cesarean section with a pre-diagnosis of PAS were analyzed retrospectively. The choice of anesthesia applied to the patients and the relationship between the use of blood products and bleeding were evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our study was designed as a retrospective randomized study. Patients aged 20-50 years and >34 weeks of gestation who accepted the birth with a cesarean section with a pre-diagnosis of PAS were evaluated retrospectively.

examined. were randomized into 2 groups, 53 patients in each group: group1: GNF : the group without fibrinogen concentrate

Group 2: GF: the group with fibrinogen concentrate

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

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
    • Basaksehir
      • Istanbul, Basaksehir, Turkey
        • Duygu Akyol

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

Yes

Description

Inclusion Criteria:

  • 20-50 years PAS pre-diagnosed pregnant women
  • >34 weeks of pregnancy
  • Those with normal renal functions

Exclusion Criteria:

  • Patients with renal insufficiency
  • Those with <34 weeks of gestation
  • Pregnant women with missing data

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: grup 1: the group without fibrinogen concentrate (GNF)
Procedure: the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)
the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF)
Other Names:
  • group 1: the group without fibrinogen concentrate (GNF)
  • group 2: the group with fibrinogen concentrate (GF)
Experimental: Grup 2: the group with fibrinogen concentrate
Procedure: the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)
the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF)
Other Names:
  • group 1: the group without fibrinogen concentrate (GNF)
  • group 2: the group with fibrinogen concentrate (GF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laboratory hemoglobin level(g/dl)
Time Frame: Change from preoperative to postoperative day 1(POD 1) hemoglobin values (g/dl).
Our primary aim was to evaluate the postoperative day 1(POD 1) hemoglobin values(g/dl).
Change from preoperative to postoperative day 1(POD 1) hemoglobin values (g/dl).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensive care unit (ICU) admission and length of stay.
Time Frame: postoperatively up to 1 months
The secondary aim was to investigate the intensive care unit (ICU) admission and length of stay.
postoperatively up to 1 months

Collaborators and Investigators

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

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: Duygu Akyol, Basaksehir Cam & Sakura Şehir Hospital

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, 2022

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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