Fibrinogen Concentrate and Placenta Acreta Spectrum

Not Applicable

Completed

• Conditions: Placenta Accreta; Obstetric Anesthesia Problems
• Interventions: Procedure: the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)

• Registration Number: NCT05938062
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-10-01
• Study Completion: 2023-05-01
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-29
• Status Verified: 2023-07
• Study First Posted: 2023-07-10
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup 2: the group with fibrinogen concentrate	the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)	Grup 2: the group with fibrinogen concentrate
grup 1: the group without fibrinogen concentrate (GNF)	the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)	grup 1: the group without fibrinogen concentrate (GNF)

Primary Outcome Measures

Name	Time	Method
Laboratory hemoglobin level(g/dl)	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).

Secondary Outcome Measures

Name	Time	Method
The intensive care unit (ICU) admission and length of stay.	postoperatively up to 1 months	The secondary aim was to investigate the intensive care unit (ICU) admission and length of stay.

Trial Locations

Locations (1)

Duygu Akyol; 🇹🇷 Istanbul, Basaksehir, Turkey