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Completed

NCT Number: NCT05938062

Fibrinogen Concentrate and Placenta Acreta Spectrum

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.

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Key information

Conditions

Obstetric Anesthesia Problems Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Accreta Placenta Diseases Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duygu Akyol

Istanbul, Basaksehir, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

Primary outcomes

  1. Laboratory hemoglobin level(g/dl)

    Time frame: 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 outcomes

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

    Time frame: postoperatively up to 1 months

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

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 10, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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