Ultrasound Staging in the Placenta Accreta

Obstetric Labor Complications Clinical Trial

Official title:

Efficacy of Ultrasound Staging System in Prediction of Morbidly Adherent Placenta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253197
• Other study ID #: Beni-Suef 3-2017
• Status: Completed
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: December 25, 2019

Study information

• Verified date: January 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.

Description:

Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta accreta, increta, and percreta, which are associated with significant maternal and fetal morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta include the loss of myometrial interface or retroplacental clear space, reduced myometrial thickness and the presence of intraplacental lacunae. Using a staging system by antenatal ultrasound can predict placental invasion antenatally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 25, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Prior lower segment cesarean section

• Low lying anterior placenta

• Singleton pregnancy

Exclusion Criteria:

• Medical disorders

• vasa previa

Related Conditions & MeSH terms

• Obstetric Labor Complications
• Staging of Placental Invasion

Intervention

Device:
• Ultrasound
Pregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted.

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Albayrak M, Ozdemir I, Koc O, Demiraran Y. Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):377-80. doi: 10.1111/j.1479-828X.2011.01309.x. Epub 2011 Apr 18. — View Citation

American institute of ultrasound in medicine 2015.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of the stage of myometrial placental invasion	By ultrasound, placental invasion in myometrium was given a stage	1 hour
Secondary	Blood loss	Documentation of complications intraoperative	1 hour