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Placenta Accreta New Detection Procedure by Rapid Assessment of Serum BNP (PANDORA)

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ClinicalTrials.gov Identifier: NCT04215484
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Ben marzouk Sofiene, University Tunis El Manar

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 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.


Condition or disease Intervention/treatment
Placenta Accreta Placenta Previa Normal Pregnancy Diagnostic Test: serum BNP assessment

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Does Serum BNP Predict Abnormal Placental Invasion During Pregnancy
Estimated Study Start Date : January 2, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
P
P (previa) : pregnant women with placenta previa on ultrasound and no suggestive signs of placenta accreta
Diagnostic Test: serum BNP assessment
serum BNP assessment in pregnant women with placenta previa, associated or not to a suspected abnormal placental invasion, compared to a control group

I
I (abnormal placental Invasion) : pregnant women with placenta previa on ultrasound,and suggestive signs of placenta accreta on ultrasound with or without MRI
Diagnostic Test: serum BNP assessment
serum BNP assessment in pregnant women with placenta previa, associated or not to a suspected abnormal placental invasion, compared to a control group

N
N (placenta normally located) : pregnant women without suggestive signs of placenta previa or accreta on ultrasound
Diagnostic Test: serum BNP assessment
serum BNP assessment in pregnant women with placenta previa, associated or not to a suspected abnormal placental invasion, compared to a control group




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. blood loss [ Time Frame: from the beginning of cesarean section to bleeding control : up to 48 hours ]
    compare the amount of blood loss in group P,I and N

  2. blood transfusion [ Time Frame: from the beginning of cesarean section to achieving hemodynamic stability : up to 48 hours ]
    compare blood transfusion requirements in group P,I and N


Biospecimen Retention:   Samples Without DNA
blood serum


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04215484


Contacts
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Contact: Sofien Ben Marzouk, as PR 99941968 ext +216 SOFIENE.BENMARZOUK@FMT.UTM.TN
Contact: Hayen Maghrebi, PROFESSOR 94683905 ext +216 MAGHREBI.HAYEN@YAHOO.FR

Locations
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Tunisia
Tunis maternity and neonatology center, minisetry of public health
Tunis, Tunisia, 1007
Contact: Hayen Maghrebi, professor    22921379 ext +216    hayen.maghrebi@yahoo.fr   
Sponsors and Collaborators
Ben marzouk Sofiene
Investigators
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Study Chair: Hayen Maghrebi, PROFESSOR University Tunis El Manar
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Responsible Party: Ben marzouk Sofiene, clinical associate professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT04215484    
Other Study ID Numbers: BNP-ACCRETA
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ben marzouk Sofiene, University Tunis El Manar:
placenta previa
placenta accreta
BNP
cesarean section
pregnancy
Additional relevant MeSH terms:
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Placenta Previa
Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases