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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040748
Receipt No. R000046520
Scientific Title Treatment Options of Adolescent Gestational Diabetes: Effect on Outcome
Date of disclosure of the study information 2020/06/13
Last modified on 2020/06/13

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Basic information
Public title
Adolescent Gestational Diabetes outcomes
Acronym AGDO
Scientific Title Treatment Options of Adolescent Gestational Diabetes: Effect on Outcome
Scientific Title:Acronym TOAGDEO
Region
Asia(except Japan)

Condition
Condition Adolescent pregnant ladies
Classification by specialty
Endocrinology and Metabolism Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of different management plans of gestational diabetes in teenagers including insulin, metformin (as an oral anti-diabetic agent), and lifestyle without pharmacological treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Maternal glycemic control
Key secondary outcomes Preeclampsia, gestational length, delivery mode.
Neonatal outcomes including: preterm birth, large or small for gestational age, macrosomia, delivery weight, hypoglycemia, Apgar score, and admission to NICU.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 metforim
Interventions/Control_2 diet
Interventions/Control_3 insulin
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit
19 years-old >=
Gender Female
Key inclusion criteria adolescent pregnant mothers
singletone
has the diagnosis of gestational diabetes
Key exclusion criteria chronic illness like diabetes before pregnancy
Target sample size 61

Research contact person
Name of lead principal investigator
1st name Shaymaa
Middle name Kadhim
Last name Jasim
Organization University of Baghdad
Division name College of Medicine
Zip code 00964
Address Bab Al-Moaddam, Baghdad, Iraq.
TEL 009647811284170
Email shaimaa79kadhim@gmail.com

Public contact
Name of contact person
1st name Hayder
Middle name
Last name Al-Momen
Organization University of Baghdad
Division name Al-Kindy College of Medicine
Zip code 00964
Address Al-Nahda square, baghdad, Iraq.
TEL 009647811284169
Homepage URL
Email hayder77almusawi@gmail.com

Sponsor
Institute University of Baghdad

Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization university of Baghdad
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Baghdad
Address Bab Al-Moaddam, Baghdad, Iraq.
Tel 009647727289433
Email sarmarsarmar@yahoo.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Medical City Hospital in Baghdad

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 13 Day

Related information
URL releasing protocol https://data.mendeley.com/datasets/3jgzvk58sy/1
Publication of results Unpublished

Result
URL related to results and publications https://data.mendeley.com/datasets/3jgzvk58sy/1
Number of participants that the trial has enrolled 61
Results Metformin is the best option
Results date posted
2020 Year 06 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Matched adolescent pregnant mothers
Participant flow Metformin group= 19
Insulin group= 17
Lifestyle group= 11
Adverse events obstetrical and neonatal events were more in insulin group.
Outcome measures Glycemic control was the least in insulin group.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 04 Month 05 Day
Date of IRB
2016 Year 05 Month 02 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 25 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 06 Day
Date analysis concluded
2020 Year 04 Month 09 Day

Other
Other related information

Management information
Registered date
2020 Year 06 Month 13 Day
Last modified on
2020 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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