Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001169730
Ethics application status
Approved
Date submitted
28/09/2013
Date registered
23/10/2013
Date last updated
23/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
How effective is misoprostol alone in termination of first trimester viable pregnancy?
Scientific title
women who received misoprostol to terminate their first trimester pregnancy are followed up till the end of their pregnancy whether by abortion or livebirth.
Secondary ID [1] 283322 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Termination of first trimester viable pregnancy 290213 0
Condition category
Condition code
Reproductive Health and Childbirth 290604 290604 0 0
Abortion

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Clinical and sonographic follow up every 4 weeks till the end of pregnancy by miscarriage or delivery, in women who have taken misoprostol to deliberately terminate the current pregnancy.
Intervention code [1] 288044 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290618 0
Neonatal outcome as assessed by clinical examination of the newborn by pediatrician evaluation of Apgar score and exclusion or detection of anomalies.
Timepoint [1] 290618 0
end of pregnancy
Secondary outcome [1] 304919 0
Nil.
Timepoint [1] 304919 0
Nil

Eligibility
Key inclusion criteria
pregnant women presented in their first trimester after intake of misoprostol to deliberately terminate the current pregnancy.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Intake of other drugs during the same period.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/07/2011
Actual
30/07/2011
Date of last participant enrolment
Anticipated
1/07/2013
Actual
20/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5449 0
Egypt
State/province [1] 5449 0

Funding & Sponsors
Funding source category [1] 288056 0
Self funded/Unfunded
Name [1] 288056 0
Country [1] 288056 0
Primary sponsor type
Individual
Name
Mervat sheikhelarab Elsedeek Omran. Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address
649 Elhoreya road, Alexandria Egypt.
03312
Country
Egypt
Secondary sponsor category [1] 286779 0
None
Name [1] 286779 0
Address [1] 286779 0
Country [1] 286779 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289981 0
Alexandria Faculty of Medicine institutional review board.
Ethics committee address [1] 289981 0
Alexandria Faculty of Medicine, Elazarita, Alexandria, Egypt.
03312
Ethics committee country [1] 289981 0
Egypt
Date submitted for ethics approval [1] 289981 0
25/03/2011
Approval date [1] 289981 0
10/04/2011
Ethics approval number [1] 289981 0

Summary
Brief summary
women reporting first trimester use of misoprostol were evaluated by ultrasonography to detect the condition of pregnancy. If pregnancy was still present and viable, monthly follow up clinically and by ultrasound was arranged till the end of pregnancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43306 0
Prof Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 43306 0
649 Elhoreya road, Alexandria, Egypt.
post code:03312
Country 43306 0
Egypt
Phone 43306 0
+203 5759915
Fax 43306 0
Email 43306 0
[email protected]
Contact person for public queries
Name 43307 0
Prof Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 43307 0
649 Elhoreya road, Alexandria, Egypt.
03312
Country 43307 0
Egypt
Phone 43307 0
+203 5759915
Fax 43307 0
Email 43307 0
[email protected]
Contact person for scientific queries
Name 43308 0
Prof Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 43308 0
649 Elhoreya road, Alexandria, Egypt.
03312
Country 43308 0
Egypt
Phone 43308 0
+203 5759915
Fax 43308 0
Email 43308 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.