NCT05938062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

June 22, 2023

Last Update Submit

July 31, 2023

Conditions

Obstetric Anesthesia ProblemsPlacenta Accreta

Keywords

fibrinogen concentrateobstetric anesthesiaplasenta acreata spectrumpostpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Laboratory hemoglobin level(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 Outcomes (1)

  • The intensive care unit (ICU) admission and length of stay.

    postoperatively up to 1 months

Study Arms (2)

grup 1: the group without fibrinogen concentrate (GNF)

EXPERIMENTAL

grup 1: the group without fibrinogen concentrate (GNF)

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

Grup 2: the group with fibrinogen concentrate

EXPERIMENTAL

Grup 2: the group with fibrinogen concentrate

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

Interventions

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

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

Also known as: group 1: the group without fibrinogen concentrate (GNF), group 2: the group with fibrinogen concentrate (GF)
Grup 2: the group with fibrinogen concentrategrup 1: the group without fibrinogen concentrate (GNF)

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duygu Akyol

Istanbul, Basaksehir, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 33204176BACKGROUND

  • 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.

    PMID: 30821559BACKGROUND

  • 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.

    PMID: 30025661RESULT

MeSH Terms

Conditions

Placenta AccretaPostpartum Hemorrhage

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological Factors

Study Officials

  • Duygu Akyol

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
retrospective randomized study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: retrospective randomized study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 10, 2023

Study Start

January 1, 2022

Primary Completion

October 1, 2022

Study Completion

May 1, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)