Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201503001059248 Date of Approval: 06/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study the use of metformin versus placebo for prophylaxis from gestational diabetes in high risk patients
Official scientific title Comparative study the use of metformin versus placebo for prophylaxis from gestational diabetes in high risk patients
Brief summary describing the background and objectives of the trial Gestational diabetes is a health compromising condition that affects 6-8% of pregnant females. Metformin is an insulin sensitizing medicationwith known safety profile during pregnancy. The use of this drug has been proposed in several trials for prevention of gestational diabetes in high risk groups
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied gestational diabetes,Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2015
Actual trial start date
Anticipated date of last follow up 01/01/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Metformin medication 850 mg twice a day from 14 weeks gestation till delivery oral medication 150 Placebo
Control Group Placebo in th form of pyridoxine tablets 50mg tablet once a day from 14wks gestation till delivery oral medicaton 150 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Obese patients with body mass index above 30. ii. Patients with history of gestational diabetes. iii. Patients with history of gestational diabetes in previous pregnancies. iv. Patients with multiple gestation. v. Pateints with family history of gestational diabetes in siblings or type 2 diabetes in parents. vi. Patients with polycystic ovarian disease 1- Patients with pre-gestational diabetes 2- Patients with intolerance to metformin e.g. hypersensitivity to the medication. 18 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/02/2015 Alexandria university-Faculty of Medicine-Ethics committee
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine-Raml station Alexandria Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevention of gestational diabetes 1-Performing 75 gm glucose tolerance test at a]18 weeks b]28 weeks c]34 weeks
Secondary Outcome prevention of maternal or fetal complications Birth of the fetus
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shatby Maternity university hospital Army road Alexandria 00203 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 8 faculty of medicine street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tamer Mamdouh Abdel Dayem 8 faculty of medicine street, Raml station Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tamer Mamdouh Abdel Dayem 8 faculty of medicine street, Raml station Alexandria 21514 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 18 pharanaa street, Azarita
City Postal code Country Position/Affiliation
alexandria 21514 Egypt Lecturer of obstetrics-University of Alexandria
Role Name Email Phone Street address
Public Enquiries Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 8 faculty of medicine street, Raml station
City Postal code Country Position/Affiliation
alexandria 21514 Egypt lecturer of obstetrics-University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 8 faculty of medicine street, Raml station
City Postal code Country Position/Affiliation
alexandria 21514 Egypt Lecturer of obstetrics-University of Alexandria
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information