Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000698673
Ethics application status
Approved
Date submitted
16/06/2014
Date registered
2/07/2014
Date last updated
2/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
In women with unexplained recurrent abortion, is prophylactic use of low dose aspirin and Calheparin more effective than no treatment in increasing the number of patients who complete their first trimester?
Scientific title
In women with unexplained recurrent abortion, is prophylactic use of low dose aspirin and Calheparin more effective than no treatment in increasing the number of patients who complete their first trimester?
Secondary ID [1] 284812 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unexplained recurrent abortion 292193 0
Condition category
Condition code
Reproductive Health and Childbirth 292532 292532 0 0
Abortion

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
180 pregnant women with history of recurrent unexplained pregnancy loss classified into 2 groups Group 1 included 90 women received low dose aspirin orally 75 mg once daily and heparin 5000 IU subcutaneous every 12 hours started at 8 weeks gestation till the end of 12th week. Group 2 included 90 women received no treatment. Monitoring adherence to treatment was done by counting drug tablets return and counting number of used syringes every 2 weeks
Intervention code [1] 289600 0
Treatment: Drugs
Intervention code [2] 289648 0
Prevention
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 292390 0
number of patients who completed their first trimester
Timepoint [1] 292390 0
12 weeks pregnancy
Secondary outcome [1] 308859 0
complications of treatment e.g Transient thrombocytopenia, Gastrointestinal troubles, Bruising at injection site, Epistaxis and bleeding gums. Complications were assessed by patients symptoms and examinations.
Timepoint [1] 308859 0
12 weeks pregnancy

Eligibility
Key inclusion criteria
1. Gestational age 5-7 weeks
2. history of three or more spontanous abortions without an obvious cause
Minimum age
19 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with documented cause of recurrent abortion as antiphospholipid syndrome
2. history of thrombo-embolic manifestations
3.medical disorder as diabetes or hypertension
4. chronic disorder like renal cardiac or liver disease
5.those with structural anomalies of the uterus

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Results are expressed as mean +/- standard deviation (SD) or number (%). Comparison between the mean values of different variables in the two groups was performed using unpaired student t test.
Comparison between categorical data was performed using Chi square test. SPSS computer program (version 12 windows) was used for data analysis. P value less or equal to 0.05 was considered significant and less than 0.01 was considered highly significant
Power analysis: As the primary outcome in the study, power analysis was done on the completion of first trimester. Fisher Exact test was chosen to perform the power analysis, the a-error level was fixed at 0.05 and the sample size was entered to be 180 participants divided equally into 2 groups . completion of first trimester had occurred in 73.33% of cases in group I and 43.33% in group 2.According to this effect size, the calculated statistical power was > 99.9%. Calculations were done using PS Power and Sample Size Calculations Software, version 3.0.11 for MS Windows (William D. Dupont and Walton D. Vanderbilt, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
1/06/2011
Date of last participant enrolment
Anticipated
30/09/2013
Actual
30/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 6152 0
Egypt
State/province [1] 6152 0
Cairo

Funding & Sponsors
Funding source category [1] 289425 0
Self funded/Unfunded
Name [1] 289425 0
Ahmed Maged
Country [1] 289425 0
Egypt
Primary sponsor type
Individual
Name
Ahmed Maged
Address
Kasr Alaini medical school.
135 king faisal street
Haram Giza Postal code 12151
Country
Egypt
Secondary sponsor category [1] 288112 0
Individual
Name [1] 288112 0
Aly Abdlhafiz
Address [1] 288112 0
Kasr Alaini medical school.425 Haram street Giza postal code 12156
Country [1] 288112 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
Brief summary
to study the effect of prophylactic use of low dose aspirin and heparin on patients with recurrent unexplained pregnancy loss
Methods: prospective case control study conducted on 180 pregnant women randomized into 2equal groups. Group 1 received low dose aspirin 75 mg and heparin 5000 IU subcutaneous every 12 hours. Group 2 received no treatment
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49242 0
Dr Ahmed Maged
Address 49242 0
Kasr Alaini medical school.135 king Faisal street haram giza postal code 12151
Country 49242 0
Egypt
Phone 49242 0
+20201005227404
Fax 49242 0
Email 49242 0
[email protected]
Contact person for public queries
Name 49243 0
Dr Ahmed Maged
Address 49243 0
Kasr Alaini medical school.135 king Faisal street haram giza postal code 12151
Country 49243 0
Egypt
Phone 49243 0
+20201005227404
Fax 49243 0
Email 49243 0
[email protected]
Contact person for scientific queries
Name 49244 0
Dr Ahmed Maged
Address 49244 0
Kasr Alaini medical school.135 king Faisal street haram giza postal code 12151
Country 49244 0
Egypt
Phone 49244 0
+20201005227404
Fax 49244 0
Email 49244 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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