Could Colour Dopper Improve the Diagnosis of Retained Placental Fragments After Second Trimester Miscarriage ?

Miscarriage Clinical Trial

Official title:

Value of Pelvic Ultrasonography and Colour Doppler in Diagnosing Retained Placental Fragments After Mid Trimester Miscarriage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02419300
• Other study ID #: USDIA
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2015
• Last updated: February 15, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: Ain Shams University
• Contact: Ahmed dr Mohamed, M.D
• Phone: 201008681999
• Email: ahmedmkotp[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.

Description:

This is a study for diagnostic accuracy test where all patients will undergo US and Doppler examination after second trimester miscarriage. Then all patients with endometrial mass on US will undergo colour Doppler then surgical evacuation and results of histopathology will be recorded.

Now, pathological examination of suction evacuation products is considered the gold standard so sensitivity, specificity, PPV and NPV of US and Doppler are the primary outcome

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnancy duration: early mid-trimester from 14 to 20 weeks

• Endometrial mass upon ultrasound examination after second trimesteric miscarriage

Exclusion Criteria:

• Uterine congenital anomaly

• Patients with signs of sepsis.

• Negative scan after second trimesteric miscarriage

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage

Intervention

Device:
• ultrasoungraphy
pelvic ultrasonography and Doppler

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, PPV and NPV of Doppler in diagnosis of retained placental fragments after second trimester miscarriage	All patients with endometrial mass after spontineous or medical miscarriage will undergo colour Doppler examination within 1 hour of miscarriage	60 minutes after delivery