Placenta Accreta New Detection Procedure by Rapid Assessment of Serum BNP

NCT04215484 | Completed

• 1 other identifier: BNP-ACCRETA
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta; Placenta Previa; Normal Pregnancy

Keywords

placenta previa; placenta accreta; BNP; cesarean section; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

  from the suspected diagnosis to study completion : up to 5 months

Secondary Outcomes (2)

• blood loss

  from the beginning of cesarean section to bleeding control : up to 48 hours

• blood transfusion

  from the beginning of cesarean section to achieving hemodynamic stability : up to 48 hours

Study Arms (3)

P

P (previa) : pregnant women with placenta previa on ultrasound and no suggestive signs of placenta accreta

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

Diagnostic Test: serum BNP assessment

N

N (placenta normally located) : pregnant women without suggestive signs of placenta previa or accreta on ultrasound

Diagnostic Test: serum BNP assessment

Interventions

serum BNP assessment DIAGNOSTIC_TEST

serum BNP assessment in pregnant women with placenta previa, associated or not to a suspected abnormal placental invasion, compared to a control group

I; N; P

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Ben marzouk Sofiene: lead

Study Sites (1)

Tunis maternity and neonatology center, minisetry of public health

Tunis, 1007, Tunisia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum

MeSH Terms

Conditions

Placenta Accreta; Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Hayen Maghrebi, PROFESSOR

  University Tunis El Manar

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical associate professor

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 2, 2020
• Study Start: January 2, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

TU (1)