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Effect of Antenatal Steroid before Elective Cesarean Section(C/S) on Prevention of Respiratory Morbidity of Term Neonates.

Protocol summary

Summary
General Purpose: To determine the effect of antenatal steroid before Elective C/S on prevention of respiratory morbidity of term neonates. Study design: Randomized, clinical trial without placebo in two centers. The population of the study are babies born to pregnant women admitted to hospital for elective cesarean section in Yahyanejad and Babol Clinic Hospital due to repetitive C/S , in summer till winter 2015. Inclusion criteria for the mothers; Gestational age ≥39 weeks (based on ultrasound examination) and maternal cesarean section indications only because of repetitive C/S. Exclusion criteria for the mothers; mothers with premature delivery, infection, diabetes, premature rupture of membranes and the use of steroids before birth and also C/s because of other reasons( other than the repeated C/S, such as medical or obstetric underlying disease, for example cephalopelvic disproportion, retinal detachment, and macrosomia. Inclusion criteria for neonates; All infants with gestational age of ≥39 weeks (which is based on ultrasound examination and also by the researcher’s physical examination after birth by the New Ballard Scoring system.). Exclusion criteria for neonates; Undelying diseases such as IUGR, macrosomia , perinatal infection, congenital anomalies (Congenital heart diseases, etc.).Mothers are randomly divided into two groups. In this study, for each group of 50 samples were taken. The first groups of mothers’ were given Betamethasone (12 mg, daily ,IM, for tow days) within the at least 48 hours before the C/S, but the second groups of mothers’ were given nothing ,took only the usual routine care before the C/S. The neonates in both groups after birth were observed for any respiratory problems, including tachypnea, retraction, grunting and cyanosis and also for the requiring any resuscitations immediately after birth. Data like need to be admitted to the neonatal unit, or NICU and doing diagnostic and therapeutic studies were gathered. The incidence of respiratory problems after birth, the diagnosis of the underlying cause of distress, need for hospitalization, length of hospital stay and the need for oxygen administration in the two groups are compared. Data were collected by a questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090923963N1
Registration date: 2015-11-13, 1394/08/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Mohammad Hossein Kalantar
Name of organization / entity
Babol
Country
Iran (Islamic Republic of)
Phone
+98 11 3255 2438
Email address
h.kalantar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol university of medical, Street Ganjafrooz, Babol
Expected recruitment start date
2015-08-03, 1394/05/12
Expected recruitment end date
2016-02-01, 1394/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Antenatal Steroid before Elective Cesarean Section(C/S) on Prevention of Respiratory Morbidity of Term Neonates.
Public title
Effect of Antenatal Steroid before Elective Cesarean Section(C/S) on Prevention of Respiratory Morbidity of Term Neonates.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for the mothers; gestational age ≥39 weeks (based on ultrasound examination) and maternal cesarean section indications only because of repetitive C/S. Exclusion criteria for the mothers; mothers with premature delivery, infection, diabetes, premature rupture of membranes and the use of steroids before birth and also C/s because of other reasons( other than the repeated C/S, such as medical or obstetric underlying disease, for example cephalopelvic disproportion, retinal detachment, and macrosomia. Inclusion criteria for neonates; All infants with gestational age of ≥39 weeks (which is based on ultrasound examination and also by the researcher’s physical examination after birth by the New Ballard Scoring system.). Exclusion criteria for neonates; Underlying diseases such as IUGR, macrosomia , perinatal infection, congenital anomalies (Congenital heart diseases, etc.).
Age
To 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
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
Babol University of Medical Sciences Ethics Committee
Street address
Babol University of Medical Sciences Ethics Committee, Ganjafrooz Street, Babol
City
Babol
Postal code
4136747176
Approval date
2015-07-28, 1394/05/06
Ethics committee reference number
5808

Health conditions studied

1

Description of health condition studied
Respiratory distress of newborn
ICD-10 code
P22.0 - P2
ICD-10 code description
Respiratory distress syndrome of newborn- Transient tachypnoea of newborn

Primary outcomes

1

Description
Need for resuscitation, Respiratory distress, Need for oxygen administration, Need to be admitted to the neonatal unit, or NICU and doing diagnostic and therapeutic studies, Need for hospitalization, Length of hospital stay
Timepoint
After birth
Method of measurement
Clinical examination

Secondary outcomes

1

Description
Respiratory distress syndrome and Transient tachypnea of the newborn
Timepoint
After birth
Method of measurement
Clinical examination

Intervention groups

1

Description
Mothers are randomly divided into two groups. In this study, for each group 50 samples were taken. The first groups of mothers’ were given Betamethasone(ampoule 4 mg/ml),12 mg, daily, IM, for tow days, within the at least 48 hours before the C/S.
Category
Prevention

2

Description
but the second groups of mothers’ were given nothing (Without receiving placebo) ,took only the usual routine care before the C/S. The neonates in both groups after birth were observed for any respiratory problems, including tachypnea, retraction, grunting and cyanosis and also for the requiring any resuscitations immediately after birth. Data like need to be admitted to the neonatal unit, or NICU and doing diagnostic and therapeutic studies were gathered. The incidence of respiratory problems after birth, the diagnosis of the underlying cause of distress, need for hospitalization, length of hospital stay and the need for oxygen administration in the two groups are compared. Data were collected by a questionnaire.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol clinic hospital
Full name of responsible person
Dr Mohammad Hossein Kalantar
Street address
Babol clinic hospital, Babol
City
Babol

2

Recruitment center
Name of recruitment center
Yahyanejad hospital
Full name of responsible person
Kalantar Mohammad Hossein
Street address
Yahyanejad Hospital, Street Modarres, Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Dr Ali Bijani
Street address
Vice chancellor for research, Babol university of medical, Street Ganjafrooz, Babol
City
Babol
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, Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Kalantar
Position
Pediatrician
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Street Gangafrooz, Babol
City
Babol
Postal code
Phone
+98 11 3255 2438
Fax
Email
kalantar.hossein@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Mousa Ahmadpour-kacho
Position
Associate Professor
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Street Gangafrooz, Babol
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
mousa_ahmadpour@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Kalantar
Position
Periatrician
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Street Gangafrooz, Babol
City
Babol
Postal code
Phone
+98 11 3255 2438
Fax
Email
kalantar.hossein@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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