The effectiveness of Rosuvastatin on improving fetal growth restriction in pregnant women a randomized placebo controlled clinical trial
Design
clinical trial with a control group; with parallel groups; two blind strains; Randomized
Settings and conduct
Patient with fetal growth restriction who are referred to hospitals affiliated Shiraz University of medical sciences will be assigned into 2 groups with block randomization method, groupA will be treated by Rosuvastatin and groupB will be received pleacebo. underwent weekly Doppler ultrasound evaluation by one expert perinatalogist, who is blinded to the study design. Each Doppler is recorded and will compare in 2 groups. Also Apgar; birth weight,time of hospitalization in the NICU& length of pregnancy in the two groups are compared at the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:singleton pregnancy;Informed consent;GA between20 and 34 weeks;EFW less than 3 percentile;EFW by ultrasound is less than 10 with abnormal Doppler
Exclusion criteria:Preeclampsia at the time of diagnosis; chromosomal disorder and congenital defect in the fetus;Statin intolerance or allergy; myopathy; acute pulmonary edema; liver dysfunction; persistent high blood pressure despite treatment; HELLP; severe neurological symptoms
Intervention groups
Rosovastatin with a dose of 5 mg daily, is given to the participant by the doctor from the time the disorder is diagnosed until the end of the pregnancy and the participant takes it daily at a specific time.
Main outcome variables
Primary outcome: duration of pregnancy: the interval between the diagnosis of the disorder and the termination of pregnancy
Secondary outcome: birth weight, NICU admission, the first and fifth minutes after the birth of the fetus, which is expressed in numbers, the time of termination of pregnancy. which is expressed in weeks and fractions of weeks in days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140317017035N8
Registration date:2023-01-19, 1401/10/29
Registration timing:prospective
Last update:2023-01-19, 1401/10/29
Update count:0
Registration date
2023-01-19, 1401/10/29
Registrant information
Name
Maryam Kasraeian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 32365
Email address
kasraeem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Rosuvastatin on improving fetal growth restriction in pregnant women a randomized placebo controlled clinical trial
Public title
Efficacy of Rosuvastatin on improvement of fetal growth restriction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
singleton pregnancy
Gestational age between 20 and 34 weeks
The estimated gestational weight by ultrasound should be less than 3 percentile
The estimated gestational weight by ultrasound is less than 10th percentile, which is associated with abnormal Doppler sonography
Informed consent
Exclusion criteria:
Preeclampsia at the time of diagnosis
Chromosomal disorder and anomaly
Statin intolerance or allergy
Acute pulmonary edema
Liver disorder
High blood pressure despite treatment
Hellp syndrome
Severe neurological symptoms
Ductus venosus a- wave reversa
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
participants are allocated into treatment or placebo groups by block randomization method with blocks size of 4 and Allocation Assignment (1:1). Blocks with different combinations will be arranged using the random numbers obtained from Allocation Random Software. Finally, a chain of a random sequence of treatment or placebo will be specified, and based on that treatment or placebo will be given to the participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double blind RCT, neither the patients nor the physician are aware from the allocated interventions. The interventions (placebo and treatment) are enveloped, and the allocation codes are written on the envelopes. The patient will get the envelopes immediately at the clinical diagnosis of the disease. They are treated the same during the study period and at the analysis phase, the analyzer will open the code and report the results (the analyzer will be aware of the interventions).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.SUMS.REC.1401.526
Health conditions studied
1
Description of health condition studied
Intrauterine growth restriction
ICD-10 code
O36.5
ICD-10 code description
Maternal care for known or suspected poor fetal growth
Primary outcomes
1
Description
The duration of pregnancy: the interval between the diagnosis of the disorder and the termination of pregnancy
Timepoint
From the time of starting the drug until the end of pregnancy
Method of measurement
Calculate the number of days
2
Description
Umbilical artery Doppler
Timepoint
Doppler ultrasound examination at the beginning of the study and then weekly until the end of the delivery.
Method of measurement
Ultrasound
3
Description
Middle cerebral artery Doppler
Timepoint
Doppler ultrasound examination at the beginning of the study and then weekly until the end of the delivery
Method of measurement
Ultrasound
Secondary outcomes
1
Description
birth weight
Timepoint
Birth
Method of measurement
scales
2
Description
Duration of hospitalization of the fetus in the neonatal intensive care unit
Timepoint
Discharge time from NICU
Method of measurement
number of days
3
Description
Apgar one and five minutes after the birth of the fetus
Timepoint
The first minute of birth and 5 minutes after birth
Method of measurement
special form
Intervention groups
1
Description
Intervention group: 5 mg of Rosuvastatin (Poirsina company) once a day from the time of diagnosis until the time of delivery.
Category
Treatment - Drugs
2
Description
Control group: Placebo tablet made by the Faculty of Pharmacy of Shiraz University of Medical Sciences
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz university of medical sciences
Full name of responsible person
Fateme Askary
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 917 320 2755
Email
hosseinmoradisarvestani0003@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Askary
Position
Resident of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
hosseinmoradisarvestani0003@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasraeian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
maryamkasraeian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasraeian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
maryamkasraeian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Statistical Results
When the data will become available and for how long
6 month after the project completion
To whom data/document is available
By obtaining a license from the ethics committee and for scientific and research use in coordination with the main researchers
Under which criteria data/document could be used
The data is for use in this design only. If necessary, after obtaining the necessary permits from the ethics committee
From where data/document is obtainable
To researchers responsible for responding to this plan
What processes are involved for a request to access data/document
Written request Coordinated by the ethics committee 2 months