Obstetric Anesthesia ProblemsNCT05938062
Fibrinogen Concentrate and Placenta Acreta Spectrum
A study testing the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF) in people with Obstetric Anesthesia Problems and Placenta Accreta, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anesthesia Problems, Placenta Accreta
- What is being tested?
- the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-50 years PAS pre-diagnosed pregnant women
- >34 weeks of pregnancy
- Those with normal renal functions
Who cannot join
- Patients with renal insufficiency
- Those with <34 weeks of gestation
- Pregnant women with missing data
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Obstetric Anesthesia Problems, Placenta Accreta
- Being tested
- the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)
- Keywords
- fibrinogen concentrate, obstetric anesthesia, plasenta acreata spectrum, postpartum hemorrhage
- Medical subject headings
- Placenta Accreta, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)Procedure or surgery
Also called group 1: the group without fibrinogen concentrate (GNF), group 2: the group with fibrinogen concentrate (GF)
the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF)
| Study group | Role | What they receive |
|---|---|---|
| grup 1: the group without fibrinogen concentrate (GNF) | Experimental | grup 1: the group without fibrinogen concentrate (GNF) Receives: 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 Receives: Procedure: the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory hemoglobin level(g/dl)
Our primary aim was to evaluate the postoperative day 1(POD 1) hemoglobin values(g/dl).
Measured: 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.
The secondary aim was to investigate the intensive care unit (ICU) admission and length of stay.
Measured: postoperatively up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Jan 2022
- Primary completion1 Oct 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstetric Anesthesia ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- retrospective randomized study
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Duygu Akyol, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938062
- Sponsor's protocol ID
- 2023-02
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33204176Shainker 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.
PubMed 30821559DeSimone 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.
PubMed 30025661
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05938062
- Acronym / sponsor ID
- 2023-02
- Conditions
- Obstetric Anesthesia Problems, Placenta Accreta
- Keywords
- fibrinogen concentrate, obstetric anesthesia, plasenta acreata spectrum, postpartum hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- retrospective randomized study
| Arm | Type | Receives |
|---|---|---|
| grup 1: the group without fibrinogen concentrate (GNF) | Experimental | Procedure: the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)grup 1: the group without fibrinogen concentrate (GNF) |
| Grup 2: the group with fibrinogen concentrate | Experimental | Procedure: the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)Grup 2: the group with fibrinogen concentrate |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-50 years PAS pre-diagnosed pregnant women
- >34 weeks of pregnancy
- Those with normal renal functions
Key exclusion criteria (3 listed)
- Patients with renal insufficiency
- Those with <34 weeks of gestation
- Pregnant women with missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF)Also: group 1: the group without fibrinogen concentrate (GNF), group 2: the group with fibrinogen concentrate (GF)the group without fibrinogen concentrate (GNF, ) the group with fibrinogen concentrate (GF) | Procedure or surgery | Grup 2: the group with fibrinogen concentrate, grup 1: the group without fibrinogen concentrate (GNF) |
Primary outcome
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).
1 secondary outcome
The intensive care unit (ICU) admission and length of stay.
Time frame: postoperatively up to 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Background: PubMed 33204176Morlando 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.
- Background: PubMed 30821559Shainker 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.
- Results publication: PubMed 30025661DeSimone 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.
- Individual participant dataSharing planned: No
Related trials for Obstetric Anesthesia Problems
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Obstetric, Cesarean Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu Akyol principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the group without fibrinogen concentrate (GNF) , the group with fibrinogen concentrate (GF) in people with Obstetric Anesthesia Problems and Placenta Accreta, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory hemoglobin level(g/dl) (time frame: Change from preoperative to postoperative day 1(POD 1) hemoglobin values (g/dl).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05938062, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.