The effect of aspirin on Doppler findings of uterine artery, umbilical cord and midbrain in pregnant women with intrauterine growth retardation
Design
Both the experimental and control groups will be followed up until the end of pregnancy and will undergo Doppler ultrasound at 36 weeks of gestation, and the findings of Doppler ultrasound of the uterine, umbilical and middle cerebral arteries will be compared.
Settings and conduct
In this study, pregnant women undergo biometric ultrasound after 24 weeks of gestation . Mothers with fetuses below the 10th percentile will be included in the biometric ultrasound study. Mothers with fetuses below 10 percent will be randomly divided into control and test groups using a lottery. Prior to any intervention, Doppler ultrasound of the uterine, umbilical and middle cerebral arteries is performed for both test and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Mother's age is less than 40 years.
- The mother does not have an underlying disease
- is a singleton pregnancy.
Have no history of taking aspirin, anoxane, etc. during pregnancy.
Do not have preeclampsia and gestational hypertension.
- Intrauterine growth restriction is detected before 34 weeks.
Exclusion criteria:
- Patients do not cooperate to perform serial ultrasounds and do not take aspirin regularly
And women will be reluctant to continue reading.
Intervention groups
If there is no improvement in the ultrasound findings of the uterine, umbilical and middle cerebral arteries in the same test group, the aspirin dose will be increased to 150 mg and Doppler ultrasound will be performed again two weeks later.
Main outcome variables
Ultrasound findings of uterine artery, umbilical, middle patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180227038892N2
Registration date:2022-06-17, 1401/03/27
Registration timing:prospective
Last update:2022-06-17, 1401/03/27
Update count:0
Registration date
2022-06-17, 1401/03/27
Registrant information
Name
Neda Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 9024
Email address
nedahashemi1363@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-20, 1401/03/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low-dose aspirin on uterine artery doppler flow in pregnant women with intrauterine growth retardation
Public title
Effect of low-dose aspirin on uterine artery doppler flow in pregnant women with intrauterine growth retardation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The mother should be less than 40 years old.
The mother should not have an underlying disease (hypertension, lupus, diabetes, etc.).
Have a singleton pregnancy. .... not in pregnancy.
Do not have preeclampsia and hypertension.
Limit intrauterine growth before 34 weeks.
Exclusion criteria:
- Lack of cooperation of patients to perform serial ultrasounds
lack of regular use of aspirin will be the reluctance of women to continue the study.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and data analyst will not know how the groups are assigned and the study is double-blind. The person who follows the outcome of the disease in patients and the statistician who analyzes the data do not know what medication the patient has received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hazrat Rasool Akram Hospital-Sattar Khan
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-02-05, 1400/11/16
Ethics committee reference number
IR.IUMS.REC.1400.1063
Health conditions studied
1
Description of health condition studied
Doppler improvements of the umbilical artery and midbrain
ICD-10 code
P05.9
ICD-10 code description
Newborn affected by slow intrauterine growth, unspecified
Primary outcomes
1
Description
Doppler improvements of the umbilical artery and midbrain
Timepoint
Follow-up at the end of pregnancy and undergo Doppler ultrasound at 36 weeks of gestation
Method of measurement
Doppler ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant women with fetuses below 10% will be treated with 80 mg of aspirin and will have another Doppler ultrasound two weeks later. If Doppler ultrasound findings improve, the 80 mg dose will be continued until the end of pregnancy. If there is no improvement in the ultrasound findings of the uterine, umbilical and middle cerebral arteries in the same test group, the aspirin dose will be increased to 150 mg and Doppler ultrasound will be performed again two weeks later. Patients in the experimental group will receive doses of aspirin (80 or 150) until the 36th week of pregnancy.
Category
Diagnosis
2
Description
Control group: Mothers with fetuses below the 10% percentile will not receive them without any intervention.