Comparison of the effect of the early start of aspirin in the early first trimester to pregnant women's compared to the late first trimester in high-risk pregnant mothers for preeclampsia .
Comparison of the effect of the early start of aspirin in the early first trimester to pregnant women's compared to the late first trimester in high-risk pregnant mothers for preeclampsia
Design
Randomized clinical trial. Phase 3. Double-blind. Two intervention groups and control group with randomization of two-allele random blocks of size 6 with ratio of intervention to control: one to one on 100 samples in each group
Settings and conduct
In a study designed based on the demographic characteristics and maternal medical and obstetric history of high-risk women (including a history of pre-eclampsia in the patient or in the mother and sister-kidney diseases or overt diabetes or autoimmune diseases or obstetric complications such as eclampsia or chronic high blood pressure -Pregnancy-distance between pregnancies and other cases) are identified and the above women are randomly divided into two equal groups. In the first group, low-dose aspirin with a daily dose of 80 mg started at the beginning of the first trimester with the formation of the fetal heart rate and continued until the end of the 36th week of pregnancy or until delivery if it occurs before this time.
In the second group, aspirin with a dose of 80 mg started from 11-13 weeks and 6 days and until the end of 36 week or until delivery
Participants/Inclusion and exclusion criteria
All high-risk pregnant women for preeclampsia
Without any drug sensitivity to aspirin
History of abortion less than 2 times
No medical contraindications for taking aspirin
Intervention groups
intervention group: early start of aspirin
Control group: routine intervention
Main outcome variables
Preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056611N1
Registration date:2023-01-07, 1401/10/17
Registration timing:registered_while_recruiting
Last update:2023-01-07, 1401/10/17
Update count:3
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Arezoo Behzadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4614 1652
Email address
dr.behzadian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of the early start of aspirin in the early first trimester to pregnant women's compared to the late first trimester in high-risk pregnant mothers for preeclampsia .
Public title
Investigation the effect of early initiation of Aspirin in the prevention of preeclampsia in high_ risk mothers.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All high_ risk pregnant mothers for preeclampsia
Exclusion criteria:
Drug sensitivity to Aspirin
history of more than twice abortion
Any Asprin contraindication
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization, block with 2 alleles and size6
Group A is the intervention group and B is the control group
Pregnant women who go to the prenatal clinic for pregnancy care are checked for eligibility for the study based on the study criteria. People who meet the study conditions will be candidates for the study. Based on the following blocks, they will be assigned to the intervention or control group, respectively. The intervention group or A will receive aspirin earlier and in the first trimester of pregnancy in the form of packages containing pills that have no name and address and the number of which they should take until the end of pregnancy, and the people who will be assigned to the control group or B according to They receive the routine protocol of aspirin in similar packages for the second trimester of pregnancy.
How to randomly: will be based on random 4 allelic blocks: AABBAA _ AAAABB _BBAAAA _ BBBABA _ BBAABB ....
In the execution method for randomization we use the following site to determine the sequences :
https://www.sealdenvelope.com/simple -randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
The samples assigned to each group receive similar drug packages that contain the same type of drug with the same shape. The time of taking the drug in the two groups is different, and the samples of each group are unaware of the timing of the others. At the end, he records and analyzes the data and is unaware of the type of groups (A-B). Therefore, the study is double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
KeshavarzBlvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-10-18, 1401/07/26
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.215
Health conditions studied
1
Description of health condition studied
High Risk Pregnancy for preeclampsia
ICD-10 code
Z35
ICD-10 code description
Supervision of high-risk pregnancy
Primary outcomes
1
Description
Pre-eclampsia: Hypertension with proteinuria occurs for the first time after the 20th week of pregnancy. According to the definition of systolic blood pressure >= 140 mm Hg and diastolic blood pressure >= 90 mm Hg recorded at least during two measurements with an interval of 4 hours, along with one or more of the following that occurred for the first time after 20 weeks. given
Timepoint
18 weeks of pregnancy and at the end of pregnancy
Method of measurement
1- Proteinuria: Excretion >=30 mg/mol in the protein/creatinine ratio; or >=300 mg in 24-hour urine; or >=2+ in urine dipstic test.2- Evidence of dysfunction of the organs of the mother's body: including acute kidney damage (creatinine >=1 mg/dL); Liver involvement (increase of transaminases including alanine aminotransferase or aspartate aminotransferase >=40 iu/l); with or without pain in the epigastric region, neurological complications (eclampsia-altered state of consciousness-blurred vision-clonus-severe headache-persistent visual scotoma); or hematological changes (thrombocytopenia-diffuse intravascular coagulopathy-hemolysis).3- Utero-placental dysfunction: such as intrauterine growth restriction, abnormal Doppler of the umbilical artery or fetal death).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pregnant mothers are at high risk for preeclampsia, who take a low-dose aspirin 80 or 100 mg daily at night, at bedtime, from the beginning of the first trimester. Control group: pregnant mothers are at high risk for preeclampsia, who follow the routine protocol In the second trimester, they will have a low-dose aspirin tablet of 80 or 100 mg at night at bedtime.
Category
Prevention
2
Description
Control group: routine method of prevention of preeclampsia : in this group high risk pregnant mothers for preeclampsia who were randomly placed in this group according to the routine method that exists in the whole word and currently .It means prescribing a daily low dose aspirin pill in the above method starts from the end of the first trimester( from 12 to 14_15 weeks).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Arezoo Behzadian
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2365
Email
dr.behzadian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Ghods st.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8898 7382
Email
RESEARCH@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
Arezoo Behzadian
Position
Perinatology Fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
City
Tehran
Province
Tehran
Postal code
1487646987
Phone
+98 21 4614 1652
Fax
Email
dr.behzadian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Behzadian
Position
perinatology fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
City
Tehran
Province
Tehran
Postal code
1487646987
Phone
+98 21 4614 1652
Email
dr.behzadian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Behzadian
Position
perinatology fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
City
Tehran
Province
Tehran
Postal code
1487646987
Phone
+98 21 4614 1652
Email
dr.behzadian@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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Final Report & Article
When the data will become available and for how long
6 months after the end of study
To whom data/document is available
Family Health Research Institute
Research deputy of University
Under which criteria data/document could be used
As final report and Manuscript
From where data/document is obtainable
Family Health Research Institute
What processes are involved for a request to access data/document
The published article is available to the public. The final report will be provided following the written request