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The effect of antenatal Betamethasone on preventionofneonatal respiratory distress syndrome before elective cesarean section at term

Protocol summary

Study aim
The effect of antenatal Betamethasone on preventionofneonatal respiratory distress syndrome before elective cesarean section at term
Design
Non-randomized clinical trial, women with singleton pregnancy with elective cesarean section at week 37 to 38 weeks and 6 days will enroll in the study. After selecting patients and obtaining written consent, Patients were randomly assigned into either group of treatment (intramuscular betamethasone or in the control group according to the random numbers table. Then the women are routinely taken care of.
Settings and conduct
Study place:Tbriz Alzahra hospital Study procedure: Accidental division of patients into two groups of 100 patients.Treatment group: intramuscular injection of 12 mg betamethasone in two doses between 24 hours, 48 hours before cesarean section the second groups of mothers’ were given nothing (Without receiving placebo) ,took only the usual routine care before the C/S
Participants/Inclusion and exclusion criteria
women with singleton pregnancy with elective cesarean section at week 37 to 38 weeks and 6 days will enroll in the study. Exclusion criteria include multiple pregnancies, fetus with major congenital anomalies
Intervention groups
Treatment group: intramuscular injection of 12 mg betamethasone in two doses between 24 hours, 48 hours before cesarean section the second groups of mothers’ were given nothing ,took only the usual routine care before the C/S
Main outcome variables
Neonatal respiratory outcomes (need for CPAP or nasal cannula with high-current continuous, need for continuous high-pressure oxygen with FiO2 more than 30%, need for mechanical ventilation, need for ECMO or resuscitation at birth, respiratory distress syndrome, neonatal tachypnea, apnea, bronchopulmonary dysplasia, pneumonia, use of surfactant), the need for care in the NICU, and the duration of hospitalization.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121224011862N3
Registration date: 2019-06-22, 1398/04/01
Registration timing: prospective

Last update: 2019-06-22, 1398/04/01
Update count: 0
Registration date
2019-06-22, 1398/04/01
Registrant information
Name
Farnaz Sahaf
Name of organization / entity
Women's Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
sahaf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-23, 1398/04/02
Expected recruitment end date
2020-07-02, 1399/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of antenatal Betamethasone on preventionofneonatal respiratory distress syndrome before elective cesarean section at term
Public title
The effect of antenatal Betamethasone on preventionofneonatal respiratory distress syndrome before elective cesarean section at term
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with single pregnancy Gestational age greater than 37 weeks maternal cesarean section indications only because of repetitive C/S.
Exclusion criteria:
multiple pregnancies fetus with major congenital anomalies Oligohydroamnios Polyhydramnios
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-04-22, 1398/02/02
Ethics committee reference number
IR.TBZMED.REC.1398.071

Health conditions studied

1

Description of health condition studied
Respiratory distress of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Respiratory distress syndrome in the baby after birth
Timepoint
Every half hour until 48 hours after birth
Method of measurement
Physical examination

Secondary outcomes

1

Description
The need for admission to the neonatal intensive care unit
Timepoint
From birth to discharge
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: intramuscular injection of 12 mg betamethasone (manufactured in Iran) in two doses between 24 hours
Category
Treatment - Drugs

2

Description
Control group: Group without receive betamethasone
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farnaz Sahaf
Street address
Alzahra Hospital, South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Abolghasem Juiban
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Sahaf
Position
Associte proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
lahroudin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Sahaf
Position
Associte proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
lahroudin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Sahaf
Position
Associte proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
lahroudin@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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