Placenta AccretaPANDORANCT04215484
Placenta Accreta New Detection Procedure by Rapid Assessment of Serum BNP
An observational study of Placenta Accreta and Placenta Previa, run by Ben marzouk Sofiene at 1 site in Tunisia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta, Placenta Previa, Normal Pregnancy
- What is being tested?
- serum BNP assessment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2020to 30 May 2020
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 60 parturients free from any exclusion criteria , devided equally into 3 groups : * group P : parturients with placenta previa on ultrasound and no suggestive signs of placenta accreta * group A : parturients with placenta previa on ultrasound, and suggestive signs of placenta accreta on ultrasound and / or MRI * group C : parturients without suggestive signs of placenta previa or accreta on ultrasound
Who may be able to join
- pregnant women with suspected placenta accreta on ultrasound or MRI
- pregnant women with suspected placenta previa on ultrasound or MRI
- pregnant women without sugestive signs of placenta previa or accreta on ultrasound
- history of at least one previous uterine scar
- written and informed consent
Who cannot join
- Preterm premature rupture of membranes
- Acute anaemia or metrorrhagia
- Active labor
- Severe infections
- Arterial hypertension
- known Pulmonary hypertension
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Tunis maternity and neonatology center, minisetry of public health
Tunis, 1007
About this study
Official title: Does Serum BNP Predict Abnormal Placental Invasion During Pregnancy
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 section's 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 accreta,increta and percreta.
Read more
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.
Read the 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 invasion,the 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 anesthesiologist's 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.
- Conditions
- Placenta Accreta, Placenta Previa, Normal Pregnancy
- Being tested
- serum BNP assessment
- Keywords
- placenta previa, placenta accreta, BNP, cesarean section, pregnancy
- Medical subject headings
- Placenta Accreta, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum BNP assessmentDiagnostic test
serum BNP assessment in pregnant women with placenta previa, associated or not to a suspected abnormal placental invasion, compared to a control group
| Study group | Role | What they receive |
|---|---|---|
| P | P (previa) : pregnant women with placenta previa on ultrasound and no suggestive signs of placenta accreta Receives: Diagnostic Test: serum BNP assessment | |
| I | I (abnormal placental Invasion) : pregnant women with placenta previa on ultrasound,and suggestive signs of placenta accreta on ultrasound with or without MRI Receives: Diagnostic Test: serum BNP assessment | |
| N | N (placenta normally located) : pregnant women without suggestive signs of placenta previa or accreta on ultrasound Receives: Diagnostic Test: serum BNP assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum BNP level
compare BNP levels between group P ,I and N and compute serum BNP specificity and sensitivity in the detection of abnormal placental invasion
Measured: from the suspected diagnosis to study completion : up to 5 months
Secondary outcomes (2)
blood loss
compare the amount of blood loss in group P,I and N
Measured: from the beginning of cesarean section to bleeding control : up to 48 hours
blood transfusion
compare blood transfusion requirements in group P,I and N
Measured: from the beginning of cesarean section to achieving hemodynamic stability : up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start2 Jan 2020
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Ben marzouk Sofiene
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- Hayen Maghrebi, PROFESSOR, Study chair, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215484
- Sponsor's protocol ID
- BNP-ACCRETA
- Acronym
- PANDORA
- Status last verified
- Apr 2021
- First submitted
- 17 Dec 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Serum BNP Predict Abnormal Placental Invasion During Pregnancy
- ClinicalTrials.gov ID
- NCT04215484
- Acronym / sponsor ID
- PANDORA / BNP-ACCRETA
- Conditions
- Placenta Accreta, Placenta Previa, Normal Pregnancy
- Keywords
- placenta previa, placenta accreta, BNP, cesarean section, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ben marzouk SofieneUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 2 Jan 2020 (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 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 section's 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 accreta,increta 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 invasion,the 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 anesthesiologist's 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P | – | Diagnostic Test: serum BNP assessmentP (previa) : pregnant women with placenta previa on ultrasound and no suggestive signs of placenta accreta |
| I | – | Diagnostic Test: serum BNP assessmentI (abnormal placental Invasion) : pregnant women with placenta previa on ultrasound,and suggestive signs of placenta accreta on ultrasound with or without MRI |
| N | – | Diagnostic Test: serum BNP assessmentN (placenta normally located) : pregnant women without suggestive signs of placenta previa or accreta on ultrasound |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 60 parturients free from any exclusion criteria , devided equally into 3 groups : * group P : parturients with placenta previa on ultrasound and no suggestive signs of placenta accreta * group A : parturients with placenta previa on ultrasound, and suggestive signs of placenta accreta on ultrasound and / or MRI * group C : parturients without suggestive signs of placenta previa or accreta on ultrasound
Key inclusion criteria (5 listed)
- pregnant women with suspected placenta accreta on ultrasound or MRI
- pregnant women with suspected placenta previa on ultrasound or MRI
- pregnant women without sugestive signs of placenta previa or accreta on ultrasound
- history of at least one previous uterine scar
- written and informed consent
Key exclusion criteria (16 listed)
- Preterm premature rupture of membranes
- Acute anaemia or metrorrhagia
- Active labor
- Severe infections
- Arterial hypertension
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 |
|---|---|---|
| serum BNP assessmentserum BNP assessment in pregnant women with placenta previa, associated or not to a suspected abnormal placental invasion, compared to a control group | Diagnostic test | I, N, P |
Primary outcome
serum BNP level
Time frame: from the suspected diagnosis to study completion : up to 5 months
compare BNP levels between group P ,I and N and compute serum BNP specificity and sensitivity in the detection of abnormal placental invasion
2 secondary outcomes
blood loss
Time frame: from the beginning of cesarean section to bleeding control : up to 48 hours
blood transfusion
Time frame: from the beginning of cesarean section to achieving hemodynamic stability : up to 48 hours
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 28 Apr 2021.
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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.
Hayen Maghrebi, PROFESSOR study chair
University Tunis El Manar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta and Placenta Previa, run by Ben marzouk Sofiene at 1 site in Tunisia.
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 5 inclusion and 16 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 28 Apr 2021. 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 Tunisia. 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?
serum BNP level (time frame: from the suspected diagnosis to study completion : up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2021.