Fibrinogen Concentrate and Placenta Acreta Spectrum

NCT ID: NCT05938062

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-05-01

Brief Summary

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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

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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

Conditions

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Obstetric Anesthesia Problems Placenta Accreta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

retrospective randomized study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

retrospective randomized study

Study Groups

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grup 1: the group without fibrinogen concentrate (GNF)

grup 1: the group without fibrinogen concentrate (GNF)

Group Type EXPERIMENTAL

the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)

Intervention Type PROCEDURE

the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF)

Grup 2: the group with fibrinogen concentrate

Grup 2: the group with fibrinogen concentrate

Group Type EXPERIMENTAL

the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)

Intervention Type PROCEDURE

the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF)

Interventions

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the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)

the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF)

Intervention Type PROCEDURE

Other Intervention Names

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group 1: the group without fibrinogen concentrate (GNF) group 2: the group with fibrinogen concentrate (GF)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Duygu Akyol

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duygu Akyol

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

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Duygu Akyol

Istanbul, Basaksehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33204176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30821559 (View on PubMed)

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.

Reference Type RESULT
PMID: 30025661 (View on PubMed)

Other Identifiers

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2023-02

Identifier Type: -

Identifier Source: org_study_id

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