Comparison of the effect of betamethasone and dexamethasone on fetal, neonatal, and maternal outcomes in pregnancies of fetus with intrauterine growth disorder
Comparison of the effect of betamethasone and dexamethasone on fetal, neonatal, and maternal outcomes in pregnancies of fetus with intrauterine growth disorder
Design
This phase 3 single-blind randomized clinical trial, with parallel groups, is conducted on 50 pregnant women.
Settings and conduct
This study is conducted on women who have referred to Yas Hospital for prenatal care and have fetuses with intrauterine growth restriction.
Participants/Inclusion and exclusion criteria
All pregnant singleton patients referred to the prenatal clinic of Yas hospital at the gestational age of 26 to 34 weeks with intrauterine growth restriction fetus who are candidates to receive corticosteroids are included in the study.
Intervention groups
In the betamethasone group, 12 mg of betamethasone phosphate is injected intramuscularly upon arrival and 24 hours after the first dose. In the dexamethasone group, 6 mg of dexamethasone phosphate was injected intramuscularly upon arrival, 12 hours, and 24 hours after the first dose.
Main outcome variables
Changes in echocardiography and sonography of fetuses, changes in maternal glucose level, and occurrence of neonatal complications after corticosteroid injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240508061703N1
Registration date:2024-05-27, 1403/03/07
Registration timing:prospective
Last update:2024-05-27, 1403/03/07
Update count:0
Registration date
2024-05-27, 1403/03/07
Registrant information
Name
Behrokh Sahebdel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4216 0852
Email address
behrokh_gbwm@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of betamethasone and dexamethasone on fetal, neonatal, and maternal outcomes in pregnancies of fetus with intrauterine growth disorder
Public title
Comparison of the effect of betamethasone and dexamethasone on fetal, neonatal, and maternal outcomes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy with gestational age of 26 to 34 weeks
Fetus with intrauterine growth retardation
Fetus with corticosteroid indication
Exclusion criteria:
Corticosteroid contraindication for the mother or her fetus
Unwillingness to participate in the study
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are placed in two groups of betamethasone and dexamethasone using the random allocation rule method. 25 letters A (betamethasone) and 25 letters B (dexamethasone) are written on special papers that are not clear inside, then all of them (100 numbers) are placed in a bag and for each patient, after obtaining informed consent, a paper is randomly removed without replacement.
Blinding (investigator's opinion)
Single blinded
Blinding description
The perinatologist and pediatric cardiologist do not know about the participants' corticosteroid type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
Ethics committee of Tehran university of medical sciences, Pour Sina St., Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2023-09-05, 1402/06/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.326
Health conditions studied
1
Description of health condition studied
Respiratory distress of newborn
ICD-10 code
P22
ICD-10 code description
Respiratory distress of newborn
Primary outcomes
1
Description
Fetus echocardiography changes
Timepoint
3 times, 24 hours before and 24 and 48 hours after corticosteroid administration
Method of measurement
Fetus echocardiography
2
Description
Biometric and biophysical changes of the fetus
Timepoint
3 times, 24 hours before and 24 and 48 hours after corticosteroid administration
Method of measurement
Fetus ultrasound
3
Description
Maternal glucose level
Timepoint
3 times, 24 hours before and 24 and 48 hours after corticosteroid administration
Method of measurement
Blood sample
Secondary outcomes
1
Description
Occurrence of neonatal complications including respiratory problems, intubation, sepsis, neonatal seizures, and neonatal hypoglycemia
Timepoint
After birth
Method of measurement
Examination and evaluation of the patient
Intervention groups
1
Description
Intervention group: First (after echocardiography and ultrasound of the fetus) and 24 hours after the first dose, 12 mg of betamethasone phosphate is injected intramuscularly.
Category
Prevention
2
Description
Intervention group: First (after echocardiography and ultrasound of the fetus), 12 hours, and 24 hours after the first dose, 6 mg of dexamethasone phosphate is injected intramuscularly.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Behrokh Sahebdel
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0852
Email
behrokh_gbwm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akabari Sari
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3689
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Behrokh Sahebdel
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Nejatollahi St, Karimkhan Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0852
Fax
Email
Behrokh_gbwm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behrokh Sahebdel
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Nejatollahi St, Karimkhan Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0852
Fax
Email
Behrokh_gbwm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behrokh Sahebdel
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Nejatollahi St, Karimkhan Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0852
Fax
Email
Behrokh_gbwm@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after unidentified participants
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr.Sahebdel, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Sahebdel, behrokh_gbwm@yahoo.com
What processes are involved for a request to access data/document
Any request for data must be sent to Dr. Sahebdel by email and accompanied by a written proposal confirmed by a local ethics committee.