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Fibrinogen Concentrate and Placenta Acreta Spectrum

Primary Purpose

Obstetric Anesthesia Problems, Placenta Accreta

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obstetric Anesthesia Problems focused on measuring fibrinogen concentrate, obstetric anesthesia, plasenta acreata spectrum, postpartum hemorrhage

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Duygu Akyol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

grup 1: the group without fibrinogen concentrate (GNF)

Grup 2: the group with fibrinogen concentrate

Arm Description

grup 1: the group without fibrinogen concentrate (GNF)

Grup 2: the group with fibrinogen concentrate

Outcomes

Primary Outcome Measures

Laboratory hemoglobin level(g/dl)
Our primary aim was to evaluate the postoperative day 1(POD 1) hemoglobin values(g/dl).

Secondary Outcome Measures

The intensive care unit (ICU) admission and length of stay.
The secondary aim was to investigate the intensive care unit (ICU) admission and length of stay.

Full Information

First Posted
June 22, 2023
Last Updated
July 31, 2023
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05938062
Brief Title
Fibrinogen Concentrate and Placenta Acreta Spectrum
Official Title
Is the Use of Fibrinogen in Cesarean Section Related to Bleeding and Blood Product in Patients With Placenta Accreta Spectrum?: a Retrospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Anesthesia Problems, Placenta Accreta
Keywords
fibrinogen concentrate, obstetric anesthesia, plasenta acreata spectrum, postpartum hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
retrospective randomized study
Masking
None (Open Label)
Masking Description
retrospective randomized study
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
grup 1: the group without fibrinogen concentrate (GNF)
Arm Type
Experimental
Arm Description
grup 1: the group without fibrinogen concentrate (GNF)
Arm Title
Grup 2: the group with fibrinogen concentrate
Arm Type
Experimental
Arm Description
Grup 2: the group with fibrinogen concentrate
Intervention Type
Procedure
Intervention Name(s)
the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)
Other Intervention Name(s)
group 1: the group without fibrinogen concentrate (GNF), group 2: the group with fibrinogen concentrate (GF)
Intervention Description
the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF)
Primary Outcome Measure Information:
Title
Laboratory hemoglobin level(g/dl)
Description
Our primary aim was to evaluate the postoperative day 1(POD 1) hemoglobin values(g/dl).
Time Frame
Change from preoperative to postoperative day 1(POD 1) hemoglobin values (g/dl).
Secondary Outcome Measure Information:
Title
The intensive care unit (ICU) admission and length of stay.
Description
The secondary aim was to investigate the intensive care unit (ICU) admission and length of stay.
Time Frame
postoperatively up to 1 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duygu Akyol
Organizational Affiliation
Basaksehir Cam & Sakura Şehir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duygu Akyol
City
Istanbul
State/Province
Basaksehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33204176
Citation
Morlando M, Collins S. Placenta Accreta Spectrum Disorders: Challenges, Risks, and Management Strategies. Int J Womens Health. 2020 Nov 10;12:1033-1045. doi: 10.2147/IJWH.S224191. eCollection 2020.
Results Reference
background
PubMed Identifier
30821559
Citation
Shainker S, Shamshirsaz A, Haviland M, O'Brien K, Redhunt A, Bateni Z, Moaddab A, Fox K, Hui SK, Belfort M, Dildy G, Hacker M. Utilization and outcomes of massive transfusion protocols in women with and without invasive placentation. J Matern Fetal Neonatal Med. 2020 Nov;33(21):3614-3618. doi: 10.1080/14767058.2019.1581168. Epub 2019 Mar 1.
Results Reference
background
PubMed Identifier
30025661
Citation
DeSimone RA, Leung WK, Schwartz J. Transfusion Medicine in a Multidisciplinary Approach to Morbidly Adherent Placenta: Preparing for and Preventing the Worst. Transfus Med Rev. 2018 Oct;32(4):244-248. doi: 10.1016/j.tmrv.2018.05.007. Epub 2018 Jun 27.
Results Reference
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Fibrinogen Concentrate and Placenta Acreta Spectrum

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