Magnetic Resonance Imaging (MRI ) Versus Ultrasound in Placenta Accreta Diagnosis

Placenta Accreta, Third Trimester Clinical Trial

Official title:

Gray-scale , Colour Doppler Ultrasound and Magnetic Resonance Imaging for Diagnosis of Placenta Accreta

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03813212
• Other study ID #: MRI placenta accreta
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: January 2021

Study information

• Verified date: July 2020
• Source: Ain Shams University
• Contact: Safaa Thabet, M.B.B.,Ch
• Phone: 01067593438
• Email: Safaathabet63[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta.

Description:

Placenta accreta occurs when the chorionic villi abnormally invade the myometrium. Based on histopathology it is divided into three grades: placenta accreta (the chorionic villi are in contact with the myometrium), placenta increta (the chorionic villi invade the myometrium), and placenta percreta where the chorionic villi penetrate the uterine serosa. With increasing rate of cesarean delivery, the incidence of both placenta praevia and placenta accreta is steadily increasing in frequency.

Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal complications as it allows a preplanned treatment of the condition . Gray-scale and colour Doppler ultrasound (US) are valuable tools in the prenatal diagnosis of placenta accreta .However, if the ultrasound ( US ) findings suggest possible percreta or are inconclusive or negative in an at-risk woman, magnetic resonance imaging (MRI) can be useful.

Multiple sonographic findings are seen with placenta accreta such as decrease in myometrial thickness, placenta previa, placental lacunae, abnormal pattern of color Doppler, loss of the retroplacental clear zone and placenta percreta irregularities in wall of urinary bladder ( UB ) have been detected .

The most magnetic resonance imaging characteristic findings seen in placenta accreta are nodular thickening in the dark zone of placenta-uterine interface together with extensions of dark bands through the placenta, outer uterine bulge causing from the mass effect of the placenta and heterogeneous signal intensity of placenta on the T2-weighted HASTE sequences due to large placental lakes and vessels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Haemodynamically stable pregnant women who have the following risk factors for placenta accreta : persistent anterior placenta previa, prior uterine surgery (such as a previous cesarean section, uterine curettage, or myomectomy).

• Maternal age : 20-40 years old.

• BMI : 18-29.9 kg/m2.

Exclusion Criteria:

• Exclusion criteria will be MRI contraindications, cardiac pacemaker, metal objects in the body, and patient's refusal for MRI evaluation.

• Haemodynamically unstable patients.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta, Third Trimester

Intervention

Device:
• MRI
Magnetic resonance imaging. Trans-abdominal sonography (TAS) and transvaginal sonography (TVS) will be performed using a 3.5 or 5 MHz transabdominal convex transducer and a 7 MHz trans-vaginal transducer.

Locations

Country	Name	City	State
Egypt	Faculty of medicine ainshams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394. Review. — View Citation

Lopes ES, Feitosa FEL, Brazil AV, de Castro JDV, da Costa JIF, Araujo Júnior E, Peixoto AB, Carvalho FHC. Assessment of Sensitivity and Specificity of Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Placenta Accreta. Rev Bras Ginecol Obstet. 2019 Jan;41(1):17-23. doi: 10.1055/s-0038-1675803. Epub 2018 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of degree of placental invasion	Determination of degree of placental invasion by comparing the results obtained by ultrasound , MRI with the final pathological examination after operation ( the excised part of myometrium with the attached placenta or hysterectomy specimen ).	Baseline
Secondary	Change Maternal morbidity and mortality		Baseline