UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029070 |
|---|---|
| Receipt number | R000033247 |
| Scientific Title | The neonatal outcomes of Dexamethasone administration before scheduled cesarean delivery at term: A randomized clinical trial |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2019/09/11 02:10:05 |
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Basic information
Public title
The neonatal outcomes of Dexamethasone administration before scheduled cesarean delivery at term: A randomized clinical trial
Acronym
Antenatal steroids before elective cesarean section: Randomized clinical trial
Scientific Title
The neonatal outcomes of Dexamethasone administration before scheduled cesarean delivery at term: A randomized clinical trial
Scientific Title:Acronym
The neonatal outcomes of Dexamethasone administration before scheduled cesarean delivery at term: A randomized clinical trial
Region
| Africa |
Condition
Condition
recruiting
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of the role of giving steroids before elective cs for full term baby
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
neonatal outcomes: Occurrence of RDS, TTN or other respiratory morbidities and the need for incubation or NICU
Key secondary outcomes
Maternal outcome: Wound healing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Receive dexamethasone 8mg IM/12 hours for 3 doses with the last dose at least 24 hours before elective cs
Interventions/Control_2
Receive saline 0.9% 2ml IM/12 hours for 4 doses with the last dose at least 24 hours before elective cs
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Age 20-40years
elective cs
full term baby>=37weeks
Key exclusion criteria
selective CS
malformed baby
immature bay
refusal to participate
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta University
Division name
Ayman shehata dawood
Zip code
31111
Address
Tanta university
TEL
+201020972067
ayman.dawood@med.tanta.edu.eg
Public contact
Name of contact person
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta university
Division name
Marwa saad
Zip code
31111
Address
Tanta university
TEL
00201010477601
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta University
Obstetrics and gynecology department
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Tanta University
Address
Elgeish st., Tanta, Egypt
Tel
+201020972067
qau@med.tanta.edu.eg
Secondary IDs
Secondary IDs
YES
Study ID_1
Ayman Shehata dawood
Org. issuing International ID_1
Tanta University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
400
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033247
