Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04215484
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2019-12-17
Brief Title:
Placenta Accreta New Detection Procedure by Rapid Assessment of Serum BNP
Sponsor:
Ben marzouk Sofiene
Organization:
University Tunis El Manar
Study Overview
Official Title:
Does Serum BNP Predict Abnormal Placental Invasion During Pregnancy
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANDORA
Brief Summary:
The placenta accreta is defined as a placenta that is abnormally adherent to the myometrium It can thus invade the entire thickness of the myometrium placenta increta or even exceed the serosa and invade neighboring organs placenta percreta It is a rare obstetric pathology with significant morbidity and its management most often requires hemostatic hysterectomy Its frequency has increased significantly in recent decades due to the increased rate of caesareans
The maternity center of Tunis CMNT is a level 3 maternity center supporting over 12 000 births yearly where the caesarean sections rate is very high close to 45 of deliveries Recently we noted an increase in abnormal placental invasion incidence in 2018 we report over 60 cases of placenta accretaincreta and percreta
Early detection of these patients can help reduce potential risks Ultrasound and MRI are the main diagnostic tools but each one has weaknesses Biological approch of this diagnosis is not well studied Recently BNP has been shown to be associated with increased angiogenesis Because placenta accreta is characterized by abnormal uteroplacental neovascularization it has been hypothesized that serum BNP levels may be related to abnormal invasion of the placenta
In the literature only one study investigated the relationship between cardiac biomarkers Pro-BNP CK CK-MB and troponins and abnormalities of placental adhesion The main conclusion was that the Pro-BNP could predict placental accretisation
Thus the BNP as a mean of screening could enrich our diagnostic arsenal The purpose of our study is to determine whether or not BNP can predict abnormal placental invasion during pregnany
The maternity center of Tunis CMNT is a level 3 maternity center supporting over 12 000 births yearly where the caesarean sections rate is very high close to 45 of deliveries Recently we noted an increase in abnormal placental invasion incidence in 2018 we report over 60 cases of placenta accretaincreta and percreta
Early detection of these patients can help reduce potential risks Ultrasound and MRI are the main diagnostic tools but each one has weaknesses Biological approch of this diagnosis is not well studied Recently BNP has been shown to be associated with increased angiogenesis Because placenta accreta is characterized by abnormal uteroplacental neovascularization it has been hypothesized that serum BNP levels may be related to abnormal invasion of the placenta
In the literature only one study investigated the relationship between cardiac biomarkers Pro-BNP CK CK-MB and troponins and abnormalities of placental adhesion The main conclusion was that the Pro-BNP could predict placental accretisation
Thus the BNP as a mean of screening could enrich our diagnostic arsenal The purpose of our study is to determine whether or not BNP can predict abnormal placental invasion during pregnany
Detailed Description:
The investigators will conduct a monocentric prospective observational study including 60 pregnant women with history of at least one previous uterine scar and scheduled for cesarian delivery The participants will be divided into 3 equal groups according to the imaging data obtained by a senior ultrasonographer and the MRI data when necessary
Ultrasonography will be performed in all participants If placenta previa is diagnosed without any suggestive signs of abnormal placental invasion the patient is assigned to group P
If placenta previa is diagnosed and associated to suggestive signs of abnormal placental invasionthe patient is assigned to group I and an MRI will be performed
If the ultrasonography is free of any suggestive signs of placenta previa the patient is assigned to group N
Finally
group P pregnant women with placenta previa on ultrasound and no suggestive signs of abnormal placental invasion
group I pregnant women with placenta previa on ultrasound and suggestive signs of abnormal placental invasion on ultrasound
group N pregnant women without suggestive signs of placenta previa or abnormal placental invasion on ultrasound
After written and informed consent are obtained a standard battery of blood tests including serum BNP will be runned
For every patient the following will be recorded anthropometric measurements previous obstetric and medical history emergency or elective surgery anesthetic technique per-operative findings placenta previa placenta previa with abnormal placental invasion accreta increta percreta placenta normally located amount of blood products transfused nature of haemostasis procedures complications
Patients will be excluded if their condition may cause a rise in serum BNP during the sample collection those being preterm premature rupture of membranes acute anaemia or metrorrhagia active labor severe infections arterial hypertension known pulmonary hypertension symptoms of heart failure known hypertrophic or restrictive cardiomyopathy history of valvular or congenital heart disease atrial and ventricular tachyarrhythmias pulmonary embolism chronic obstructive pulmonary disease kidney failure or renal dysfonction liver dysfonction severe metabolic and hormone abnormalities thyrotoxicosis or diabetic ketosis drug use possibly affecting cardiovascular system beta-blocker or other cardiovascular drug
ANESTHETIC MANAGEMENT
The timing of delivery is usually between 36 and 37 weeks for group P and I and after 38 weeks for group N
General anesthesia will be performed in pregnant women from group I and P Regional anesthesia will be performed in pregnant women from group N
Hemodynamic management during anesthesia for group I will require placement of 2 peripheral large-bore venous access a desilet catheter in the femoral vein and an arterial line preoperatively
In patients from group P 2 peripheral large-bore venous access will be placed preoperatively A desilet catheter and arterial line will be obtained if necessary upon the anesthesiologist judgment
In patients from group N 1 peripheral large-bore venous access will be placed prior to the beginning of surgery
Blood transfusion requirements will be based on the hemodynamic status the amount of blood loss the need of catecholamines and the anesthesiologists experience
Peroperatively final diagnosis will be made according to surgical findings If placenta is completely and easily removed the diagnosis of abnormal placental invasion will not be retained
If placenta could not be easily and completely removed the diagnosis of abnormal placental invasion in established and the case is carried out according to our surgical and anesthetic standards of management
After collecting all groups blood samples will be analysed for BNP in a unique serie of tests
Ultrasonography will be performed in all participants If placenta previa is diagnosed without any suggestive signs of abnormal placental invasion the patient is assigned to group P
If placenta previa is diagnosed and associated to suggestive signs of abnormal placental invasionthe patient is assigned to group I and an MRI will be performed
If the ultrasonography is free of any suggestive signs of placenta previa the patient is assigned to group N
Finally
group P pregnant women with placenta previa on ultrasound and no suggestive signs of abnormal placental invasion
group I pregnant women with placenta previa on ultrasound and suggestive signs of abnormal placental invasion on ultrasound
group N pregnant women without suggestive signs of placenta previa or abnormal placental invasion on ultrasound
After written and informed consent are obtained a standard battery of blood tests including serum BNP will be runned
For every patient the following will be recorded anthropometric measurements previous obstetric and medical history emergency or elective surgery anesthetic technique per-operative findings placenta previa placenta previa with abnormal placental invasion accreta increta percreta placenta normally located amount of blood products transfused nature of haemostasis procedures complications
Patients will be excluded if their condition may cause a rise in serum BNP during the sample collection those being preterm premature rupture of membranes acute anaemia or metrorrhagia active labor severe infections arterial hypertension known pulmonary hypertension symptoms of heart failure known hypertrophic or restrictive cardiomyopathy history of valvular or congenital heart disease atrial and ventricular tachyarrhythmias pulmonary embolism chronic obstructive pulmonary disease kidney failure or renal dysfonction liver dysfonction severe metabolic and hormone abnormalities thyrotoxicosis or diabetic ketosis drug use possibly affecting cardiovascular system beta-blocker or other cardiovascular drug
ANESTHETIC MANAGEMENT
The timing of delivery is usually between 36 and 37 weeks for group P and I and after 38 weeks for group N
General anesthesia will be performed in pregnant women from group I and P Regional anesthesia will be performed in pregnant women from group N
Hemodynamic management during anesthesia for group I will require placement of 2 peripheral large-bore venous access a desilet catheter in the femoral vein and an arterial line preoperatively
In patients from group P 2 peripheral large-bore venous access will be placed preoperatively A desilet catheter and arterial line will be obtained if necessary upon the anesthesiologist judgment
In patients from group N 1 peripheral large-bore venous access will be placed prior to the beginning of surgery
Blood transfusion requirements will be based on the hemodynamic status the amount of blood loss the need of catecholamines and the anesthesiologists experience
Peroperatively final diagnosis will be made according to surgical findings If placenta is completely and easily removed the diagnosis of abnormal placental invasion will not be retained
If placenta could not be easily and completely removed the diagnosis of abnormal placental invasion in established and the case is carried out according to our surgical and anesthetic standards of management
After collecting all groups blood samples will be analysed for BNP in a unique serie of tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None