Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000309583
Ethics application status
Approved
Date submitted
27/12/2014
Date registered
1/04/2015
Date last updated
1/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound and Doppler flow study of placental invasion of myometrium and its maternal and fetal effects
Scientific title
In Pregnant women, the role of ultrasound and Doppler in prediction of placental invasion of myometrium and its relation to maternal and fetal outcome
Secondary ID [1] 285894 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Placenta accreta 293817 0
Condition category
Condition code
Reproductive Health and Childbirth 294120 294120 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ultrasound and Doppler measurement of myometrial thickness over the placenta done once at 37 weeks of gestation
Intervention code [1] 290876 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293920 0
accuracy of ultrasound and color Doppler in diagnosis of placenta accreta
Timepoint [1] 293920 0
delivery
Secondary outcome [1] 312153 0
fetal Apgar score
Timepoint [1] 312153 0
10 minutes after delivery
Secondary outcome [2] 313231 0
neonatal ICU admission
Timepoint [2] 313231 0
24 hours after delivery

Eligibility
Key inclusion criteria
pregnancy duration of 36 – 40 weeks.
230 of women had history of previous cesarean delivery or other uterine surgery and 50 are control cases
Minimum age
19 Years
Maximum age
41 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
women with severe vaginal bleeding or suspected rupture uterus and hemodynamically unstable patients

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
1/02/2010
Date of last participant enrolment
Anticipated
31/08/2013
Actual
31/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 6571 0
Egypt
State/province [1] 6571 0
Cairo

Funding & Sponsors
Funding source category [1] 290478 0
Self funded/Unfunded
Name [1] 290478 0
Ahmed maged
Country [1] 290478 0
Egypt
Primary sponsor type
Individual
Name
Ahmed Maged
Address
135 King Faisal street Haram Giza. kasr Alainy medical school. Cairo university.Post code 12151
Country
Egypt
Secondary sponsor category [1] 289517 0
Individual
Name [1] 289517 0
AbdelGany Mohamed
Address [1] 289517 0
60 Fostat appartments, 1st neighberhood, Masr ElKadeema, Cairo, Egypt.postcode 16122
Country [1] 289517 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53726 0
A/Prof Ahmed Maged
Address 53726 0
135 King Faisal street Haram Giza. kasr Alainy medical school. Cairo university.Post code 12151
Country 53726 0
Egypt
Phone 53726 0
+20201005227404
Fax 53726 0
Email 53726 0
[email protected]
Contact person for public queries
Name 53727 0
Ahmed Maged
Address 53727 0
135 King Faisal street Haram Giza. kasr Alainy medical school. Cairo university.Post code 12151
Country 53727 0
Egypt
Phone 53727 0
+20201005227404
Fax 53727 0
Email 53727 0
[email protected]
Contact person for scientific queries
Name 53728 0
Ahmed Maged
Address 53728 0
135 King Faisal street Haram Giza. kasr Alainy medical school. Cairo university.Post code 12151
Country 53728 0
Egypt
Phone 53728 0
+20201005227404
Fax 53728 0
Email 53728 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.