Fibrinogen Concentrate and Placenta Acreta Spectrum

Placenta Accreta Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05938062
• Other study ID #: 2023-02
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: July 2023
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Anesthesia Problems
• Placenta Accreta

Intervention

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)

Locations

Country	Name	City	State
Turkey	Duygu Akyol	Istanbul	Basaksehir

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	postoperatively up to 1 months