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Assessment of effect of antenatal betamethasone administration on neonatal respiratory morbidity in early term (37 to 38 weeks and 6 days) elective cesarean section

Protocol summary

Study aim
Evaluation the effect of prenatal betamethasone on neonatal respiratory morbidity in early elective cesarean section (37 to 38 weeks and 6 days)
Design
In this 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. Exclusion criteria include multiple pregnancies, fetus with major congenital anomalies, fetus with other medical or midwifery conditions that give birth earlier, receive dexamethasone or betamethasone during pregnancy, maternal severe hypertension, maternal history of peptic ulcer, and evidences of intrauterine infection. After selecting patients and obtaining written consent, the patients were randomly assigned to one of the two treatment groups (intramuscular injection of betamethasone before cesarean section) or the control group (routine treatment). Then, women are under routine care, and cesarean delivery is done routinely.
Settings and conduct
Study place: Mahdieh hospital Tehran Study procedure: Randomization of patients to intramuscular injection of betamethasone and control groups
Participants/Inclusion and exclusion criteria
Inclusion 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: multiple pregnancies, fetus with major congenital anomalies, fetus with other medical or midwifery conditions that give birth earlier, receive dexamethasone or betamethasone during pregnancy, maternal severe hypertension, maternal history of peptic ulcer, and evidences of intrauterine infection
Intervention groups
Treatment group: intramuscular injection of 12 mg betamethasone in two doses between 24 hours, 48 hours before cesarean section Control group: cesarean section without betamethasone injection
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: IRCT20120918010876N4
Registration date: 2018-01-11, 1396/10/21
Registration timing: registered_while_recruiting

Last update: 2018-01-11, 1396/10/21
Update count: 0
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Masumeh Mirza Moradi
Name of organization / entity
Prinatalogy department of Mahdieh hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 6263
Email address
m-bakhtiyari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-07-25, 1396/05/03
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of antenatal betamethasone administration on neonatal respiratory morbidity in early term (37 to 38 weeks and 6 days) elective cesarean section
Public title
Effect of steroid on neonatal respiratory morbidity in elective cesarean section in 37 weeks or later
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
referring women for early or 37 to 38 weeks and 6 days elective cesarean section singleton pregnancy
Exclusion criteria:
multiple pregnancies fetus with major congenital anomalies fetus with other medical or midwifery conditions that give birth earlier receive dexamethasone or betamethasone during pregnancy maternal severe hypertension maternal history of peptic ulcer evidences of intrauterine infection
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number table
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
Ethic's committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.sbmu.msp.rec.1396.275

Health conditions studied

1

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

Primary outcomes

1

Description
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)
Timepoint
After cesarean until patient discharge
Method of measurement
Clinical symptoms & signs

2

Description
NICU admission
Timepoint
After cesarean until patient discharge
Method of measurement
Clinical symptoms & signs

3

Description
Hospitalization duraion
Timepoint
Patient discharge
Method of measurement
Patient discharge in day and hour

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: intramuscular injection of 12 mg betamethasone in two doses between 24 hours, 48 hours before cesarean section
Category
Treatment - Drugs

2

Description
Control group: No Treatment
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh-haspital@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ali Ziayee
Street address
Next to Taleghani Hospital, Shahid Arabi St., Yemen St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti 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
Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
Full name of responsible person
Dr Zahra Joshaghani
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
z.joshaghani@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No need for publication of data file
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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