UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040748 |
|---|---|
| Receipt number | 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 | 2022/12/15 12:21:11 |
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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 | Obstetrics 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
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
hayder77almusawi@gmail.com
Sponsor or person
Institute
University of Baghdad
Department of Obstetrics and Gynecology
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046520
