Clinical trial NCT05938062: Fibrinogen Concentrate and Placenta Acreta Spectrum
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Anesthesia Problems
Placenta Accreta
Keywords: fibrinogen concentrate
obstetric anesthesia
plasenta acreata spectrum
postpartum hemorrhage
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-10
Enrollment: 146
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: retrospective randomized study
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Laboratory hemoglobin level(g/dl)
timeFrame: Change from preoperative to postoperative day 1(POD 1) hemoglobin values (g/dl).
Secondary outcomes:
measure: The intensive care unit (ICU) admission and length of stay.
timeFrame: postoperatively up to 1 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Duygu Akyol
state: Basaksehir
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Duygu Akyol
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.