UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	ayman.dawood@med.tanta.edu.eg

Sponsor
Institute	Tanta University Obstetrics and gynecology department
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033247