Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings

Morbidly Adherent Placenta Clinical Trial

Official title:

Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938050
• Other study ID #: 23-2021
• Status: Recruiting
• Start date: June 18, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: February 28, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 28 Years to 42 Years

Eligibility

Inclusion Criteria:

• Age group 28:42 years.

• Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).

• With a single living fetus in the current pregnancy.

• A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)

• Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.

Exclusion Criteria:

• Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.

• Maternal chronic medical disorders( diabetes mellitus, hypertension)

• Patients presented with severe attack of bleeding.

• Patients presented with rupture of membrane.

• Emergency delivery regardless the cause.

Related Conditions & MeSH terms

• Morbidly Adherent Placenta

Intervention

Diagnostic Test:
• Ultrasound
Ultrasound evaluation, with grayscale and color Doppler imaging.

Locations

Country	Name	City	State
Egypt	Cairo university Kasr Alainy OBGYN hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign)		June 2021- July 2022
Primary	Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse)		June 2021- July 2022
Primary	Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta)		June 2021- July 2022
Secondary	1- Correlation between US signs and intraoperative findings including morbidity and mortality		June 2021- July 2022