The cheanges of betamethasone on non-stress test (NST) and Doppler ultrasound parameters in fetuses with Intra uterine growth retardation in pregnant women referred to Imam Khomeini Hospital in Sari
Determining the changes of betamethasone on non-stress test (NST) and Doppler ultrasound parameters in fetuses with intrauterine growth restriction in pregnant women referred to Imam Khomeini Hospital, Sari
Design
Prospective cohort, determination of sample size by head count, three-way blinding, with two exposure and control groups
Settings and conduct
Prospective cohort study in Imam Khomeini Hospital, Sari, in the form of a census.
Patients are selected according to the entry and exit criteria.
The informed consent form will also be obtained after explaining the study to them.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
singleton pregnancy
Gestational age of 28 to 32 weeks and the threat of preterm delivery
Fetal growth restriction confirmed by ultrasound based on fetal growth percentage
Exit criteria:
Arrhythmia or fetal heart problems
Congenital anomaly of the fetus
Symptoms of active infection of the mother
Premature rupture of the amniotic sac (PPROM)
Pregnant women receiving benzodiazepines and narcotics
Women who give birth during the study
Mother's underlying diseases (hypertension, diabetes)
Intervention groups
First, non-stress test of NST for 20 minutes and Doppler of the umbilical MCA artery is directed to the patient.
Then 2 doses of betamethasone ampoule (12 mg) are injected intramuscularly 24 hours apart.
After 12 hours (day 1), 24 hours (day 2) and 36 hours (day 2), NST is performed again for 20 minutes.
NST will be performed in all patients in supine and left lateral position (to prevent supine hypotension).
The range of time for Doppler ultrasound (24 to 36 hours) will be after receiving two doses of betamethasone.
Main outcome variables
Doppler ultrasound parameters of the umbilical artery and MCA, Determining the base heart rate, beat-to-beat variability, increase or decrease in fetal heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231015059721N1
Registration date:2023-10-22, 1402/07/30
Registration timing:registered_while_recruiting
Last update:2023-10-22, 1402/07/30
Update count:0
Registration date
2023-10-22, 1402/07/30
Registrant information
Name
Roghayeh Bagherzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 775 0968
Email address
hrwaiter1382@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The cheanges of betamethasone on non-stress test (NST) and Doppler ultrasound parameters in fetuses with Intra uterine growth retardation in pregnant women referred to Imam Khomeini Hospital in Sari
Public title
Changes of betamethasone on non-stress test (NST) and Doppler ultrasound parameters in fetuses with growth restriction
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
1- Singleton pregnancy
2- Gestational age of 28 to 32 weeks and threat of preterm delivery
3- Fetal growth restriction confirmed by ultrasound based on fetal growth percentage
Exclusion criteria:
1- Arrhythmia or fetal heart problems
2- Congenital anomaly of the fetus
3- Symptoms of active infection of the mother
4- Premature rupture of the amniotic sac (PPROM)
5-Pregnant women receiving benzodiazepines and narcotics
6- Women who give birth during the study
7- Mother's underlying diseases (hypertension, diabetes
Age
From 14 years old to 55 years old
Gender
Female
Phase
1
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
All people including researchers, participants, outcome assessors and analysts will be blinded in this study.Only the clinical caregiver will be aware of the study process due to the protection of the patients (the clinical caregiver is the nurse, midwife or doctor of the patients who are not part of the research team, but are aware of the study process)
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences Research Center
In fetuses with growth restriction in pregnant women referred to Imam Khomeini Hospital in Sari
ICD-10 code
Z35.2
ICD-10 code description
Z35.2
Primary outcomes
1
Description
Determination of Doppler ultrasound parameters of the umbilical artery and MCA, determination of the basic fetal heart rate and beat-to-beat variability of the fetal heart rate and the increase or decrease of the fetal heart rate.
Timepoint
First, a non-stress test of NST for 20 minutes and Doppler of the umbilical MCA artery were performed for the patient, then 2 doses of betamethasone ampoule (12 mg) were injected into the patient at an interval of 24 hours. After 12 hours (day 1), 24 hours (day 2) and 36 hours (day 2), NST is performed again for 20 minutes. Time range of Doppler ultrasound (24 to 36 hours) after receiving two doses of betamethasone.
Method of measurement
Demographic and clinical characteristics questionnaire, non-stress test before and 12, 24 and 36 hours after the injection of two doses of betamethasone and doppler ultrasound 24 to 36 hours after the injection of the first dose of betamethasone
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Betamethasone receiving group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Zahra Rahmani
Street address
Mazandaran, Sari, Razi St., Imam Khomeini Educational and Medical Center (RA) Sari
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3304 4000
Email
hrwaiter1382@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Clinical Research Development Unit of Imam Khomeini Medical Education Center (RA)
Full name of responsible person
Dr. Zahra Rahmani
Street address
Razi St., Clinical Research Development Unit, Imam Khomeini Medical Training Center, Sari
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1702
Email
hrwaiter1382@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Clinical Research Development Unit of Imam Khomeini Medical Education Center (RA)
Proportion provided by this source
60
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
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Rahmani
Position
Subspecialist in Perinatology, Mazandaran University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mazandaran, Sari, Razi St., Imam Khomeini Educational and Medical Center (RA) Sari
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Email
refah@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Rahmani
Position
Subspecialist in Perinatology, Faculty of Mazandaran University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mazandaran, Sari, Razi St., Imam Khomeini Educational and Medical Center (RA) Sari
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Email
refah@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
roghayeh bagherzadeh
Position
Resident of the Gynecology and Obstetrics specialization course
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mazandaran, Sari, Razi St., Imam Khomeini Educational and Medical Center (RA) Sari
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Email
hrwaiter1382@gmail.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
Yes - There is 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
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
Title and more details about the data/document
Data collection is done at Imam Khomeini (RA) Hospital in Sari. After data collection, it will be provided to the Research Center and Research Development Unit of Mazandaran University of Medical Sciences as research documentation.
When the data will become available and for how long
At least three months after the start of sampling
To whom data/document is available
Mazandaran University of Medical Sciences, Research Center of Mazandaran University of Medical Sciences, Research Development Unit of Mazandaran University of Medical Sciences and Iran Clinical Trial Center
Under which criteria data/document could be used
To inquire about the accuracy of the sampling process, only to the centers covered by the Ethics Committee of Mazandaran University and the Clinical Trial Center of Iran.
From where data/document is obtainable
Scientific responsible person of the project, Mazandaran University of Medical Sciences, Research Center of Mazandaran University of Medical Sciences, Research Development Unit of Mazandaran University of Medical Sciences
What processes are involved for a request to access data/document
Correspondence with Mazandaran University of Medical Sciences, Research Center of Mazandaran University of Medical Sciences, Research Development Unit of Mazandaran University of Medical Sciences