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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201610001801760 |
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Date of registration:
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03/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Gestational diabetes mellitus
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Scientific title:
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Comparison of Metformin and Glyburide alone or in combination for treatment of gestational diabetes mellitus: a randomized clinical trial. |
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Date of first enrolment:
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16/10/2016 |
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Target sample size:
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120 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1801 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mohamed
Rezk |
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Address:
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Kafr Manawahla
002048
Elbajour
Egypt |
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Telephone:
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00201006237186 |
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Email:
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m_rezk9207@yahoo.com |
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Affiliation:
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Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University |
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Name:
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Mohamed
Rezk |
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Address:
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Kafr Manawahla
002048
Elbajour
Egypt |
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Telephone:
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00201006237186 |
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Email:
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m_rezk9207@yahoo.com |
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Affiliation:
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Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women diagnosed with GDM based on the 2-hour 75 g oral glucose tolerance test (OGTT) using the criteria defined by the WHO were included.
Exclusion criteria: Women with multiple pregnancies, having other associated medical disorder as heart disease, bronchial asthma & hypertension and pregnancies complicated by fetal malformations were excluded from the study.
Age minimum:
18 Year(s)
Age maximum:
34 Year(s)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Gestational diabetes
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Nutritional, Metabolic, Endocrine
Pregnancy and Childbirth
Gestational diabetes
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Nutritional, Metabolic, Endocrine
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Pregnancy and Childbirth
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Intervention(s)
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Metformin group
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Combined metformin and glyburide
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Glyburide group
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Primary Outcome(s)
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Degree of glycemic control Maternal outcome Fetal-neonatal outcome.
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Source(s) of Monetary Support
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Faculty of Medicine
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Ethics review
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Status: Approved
Approval date: 21/08/2016
Contact:
Faculty of Medicine
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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