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.: PACTR201505001142202 Date of Approval: 15/05/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Metformin and weight gain in the obese with pregnancy
Official scientific title Can metformin limit weight gain in the obese with pregnancy?
Brief summary describing the background and objectives of the trial Maternal overweight and obesity is associated with many obstetric complications. Obesity is linked to insulin resistance. Improving insulin sensitivity may therefore account for weight reduction. Metformin is a bigaunide that decreases hepatic glucose output by inhibiting gluconeogenesis and enhancing peripheral glucose uptake. It also decreases intestinal glucose absorption and increases insulin sensitivity. It was found to be effective in type 2 diabetes and polycystic ovarian syndrome through improving insulin sensitivity. Several studies proved its efficacy in the obese non- pregnants , but its role during pregnancy is not yet well-established. Objectives: we are testing the ability of metformin to limit weight gain and pregnancy complications namely gestational Diabetes and hypertension in the obese with pregnancy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obese pregnant women,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2014
Actual trial start date 01/08/2014
Anticipated date of last follow up 31/03/2015
Actual Last follow-up date 31/03/2015
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Metformin 500mg to 1500mg per day 6 months Oral hypoglycemic 100
Control Group Controls 6 months 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
BMI of ¿35 Kg/m2 pregnancy in the early second trimester Pregestational Diabetes and pregestational hypertension Pregnant women during the first trimester 18 Year(s) 38 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 30/08/2014 Alexandria Faculty of Medicine Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Azaritta Alexandria 21516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Weight gain (kg) 6 months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fleming Maternity clinic Tamaseen street Alexandria Egypt
Shabtby Maternity hospital Port Said street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Obstetrics and Gynaecology Port Said street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynaecology Port Said street Shebeen El.koom 21516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hanan Naser Port Said street Alexandria 21516 Egypt
Amani EL Sayed Fleming Maternity Clinic Alexandria Egypt
Nahla Farook Fleming Maternity Clinic Alexandria Egypt
Eman Abd el fattah Port Said street Alexandria Egypt
Tamer Abd El Daiem Port Said street Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Abd el fattah eman0eman0eman7@gmail.com 00201228434181 4 Fathia Baheeg Fleming
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Tamer Abd El Daiem tmdaiem@yahoo.com 00201226720766 50 Raml Station
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Obstetrics and Gynaecology
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