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Secondary outcomes
#1
Incidence of Small for gestational age (<5th centile) requiring delivery at<34 weeks and <37weeks
Incidence of Small for gestational age (<5th centile) requiring delivery at<34 weeks and <37weeks
Incidence of Small for gestational age (<5th centile) requiring delivery at<34 weeks and <37weeks
#2
Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at≥20 weeks.
Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at≥20 weeks.
Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at≥20 weeks.
مردهزایی یا مرگ داخل رحمی د 20 هفته یا بیشتر
مرده زایی یا مرگ داخل رحمی د 20 هفته یا بیشتر
مردهزاییمرده زایی یا مرگ داخل رحمی د 20 هفته یا بیشتر
#3
Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks
Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks
Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks
#4
Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity.
Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity.
Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity.
#5
Neonate intensive care unit admission.
Admission to Neonate Intensive Care Unit
Admission to Neonate intensive care unit admission.Intensive Care Unit
#6
Ventilation requirement is defined as the need for positive pressure
Ventilation requirement is defined as the need for positive pressure
Ventilation requirement is defined as the need for positive pressure
#7
empty
Neonatal anomaly especially gastroschisis
Neonatal anomaly especially gastroschisis
empty
آنومالیهای نوزادی بویژه گاستروشزی
آنومالیهای نوزادی بویژه گاستروشزی
empty
During the fetal period and at the time of birth
During the fetal period and at the time of birth
empty
در دوران جنینی و در زمان تولد
در دوران جنینی و در زمان تولد
empty
with ultrasound during pregnancy and postnatal examinations
with ultrasound during pregnancy and postnatal examinations
empty
با سونوگرافی در طول بارداری و معاینات بعد تولد
با سونوگرافی در طول بارداری و معاینات بعد تولد
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Arezoo Behzadian
Full name of responsible person - Persian: آرزو بهزادیان
Street address - English: Keshavarz Blvd.
Street address - Persian: بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 2365
Fax:
Email: dr.behzadian@yahoo.com
Web page address:
Name of recruitment center - English: Vali-E-Asr, Imam Khomeini Complex
Name of recruitment center - Persian: بیمارستان ولیعصر ,مجتمع بیمارستانی امام خمینی
Full name of responsible person - English: Arezoo Behzadian
Full name of responsible person - Persian: آرزو بهزادیان
Street address - English: Keshavarz Blvd.
Street address - Persian: بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 2365
Fax:
Email: dr.behzadian@yahoo.com
Web page address:
Name of recruitment center - English: Vali-E-Asr, Imam Khomeini HospitalComplex Name of recruitment center - Persian: بیمارستان ولیعصر ,مجتمع بیمارستانی امام خمینی Full name of responsible person - English: Arezoo Behzadian Full name of responsible person - Persian: آرزو بهزادیان Street address - English: Keshavarz Blvd. Street address - Persian: بلوار کشاورز City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6119 2365 Fax: Email: dr.behzadian@yahoo.com Web page address:
Protocol summary
Study aim
prevention of occurrence of early and late preeclampsia
Design
Randomized clinical trial.Assessor-blinded. Two intervention groups and control group.
Settings and conduct
At each visit, the presence of edema or preeclampsia symptoms are noted and recorded. In addition, participants are assessed for possible aspirin side effects.
Participants are randomly selected to receive low-dose aspirin, either before 11 weeks’ gestation (optimally from the detection of the fetal heart beat) in the intervention group or after 11 weeks in the control group. The cut-off gestational age to receive aspirin is 16 weeks in the control group. In both groups, the initial dose of aspirin is 80 mg per day. In both groups, aspirin will be continued until 36 weeks or in the case of premature delivery.
At 11_13 weeks and 6 days, when the gestational age is confirmed by an ultrasound study of the CRL measurement through the fetal NT measurement, the UTA-PI of uterine arteries is assessed transabdominally. In addition, a combined test for aneuploidy screening is requested through measuring the maternal serum free β-hcG and PAPP-A.
If there are criteria in both groups including:
PAPP-A < 0.4 in the first trimester or
preeclampsia risk more than or equal1 ̸ 100 to in aneuploidy screening test or
in color doppler ultrasound (the mean UTA-PI>95th percentile or bilateral notching), the initial dose of aspirin, which is 80 mg, is changed to 150 mg per day.
Participants/Inclusion and exclusion criteria
The participants are pregnant women at high-risk for preeclampsia according to the ACOG and USPSTF and SMFM guidelines.
Exclusion criteria:
mentioned on he previous page.
Intervention groups
intervention group: early start of aspirin
Control group: routine intervention
Main outcome variables
Early and late preeclampsia
General information
Reason for update
Hello, No major change have been made in the process and metodology of the trial,except for subtleties that help the audience to better and secondly,our tudy include two main parts. The first part, which has been approed in this center,is being done and the results will be announced later. And in the from of a pilo study, as well as the feaibility of conducting the main study and solving possible problems and defects on it way, it has started with 200 participants from January 2023. The second part includes the main RCT with the same metodology. For this eason, this request was made to provide a possibility to accelerate the start of the main trial, considering the success of the pilot tudy process for feasibility in he last 6 months. Thank you very much.
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056611N1
Registration date:2023-01-07, 1401/10/17
Registration timing:prospective
Last update:2023-12-21, 1402/09/30
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
2023-01-08, 1401/10/18
Expected recruitment end date
2023-12-08, 1402/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women.
Public title
Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The participants are pregnant women at high-risk for preeclampsia based on demographic characteristics and personal and obstetrics history, according to the ACOG and USPSTF and SMFM guidelines.
Exclusion criteria:
1) Hypersensitivity to nonsteroidal anti-inflammatory drug products
2) Asthma-rhinitis and nasal polyps
3) Sever renal or sever hepatic impairment.
4) History of gastrointestinal bleeding or active peptic ulcer disease
5) vaginal bleeding or significant hematoma on ultrasound.
6)gestational age > 16 week
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization, with random blocks of 4 alleles and with a size of 8.
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 start aspirin earlier and at the beginning of the first trimester of pregnancy, and the participants who will be assigned to the control group, or B will receive the routine protocol of aspirin at the end of the first trimester.
How to randomly: will be based on random 4 allelic blocks:
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)
Single blinded
Blinding description
Due to the nature of the intervention, neither participants nor researchers can be blinded to allocation. However, assessments will be conducted by a blind analyzer for trial allocation.
Placebo
Not used
Assignment
Parallel
Other design features
We calculated that the enrollment of 1792 patients in a 1:1 ratio of distribution (896 patients in each group) would provide the trial with a power of 90% (alpha level of 5%). If we allow for a 10% loss to follow-up, the sample size will reach 986 participants in each group. A total of 1972 eligible participants will be randomly entered into the trial arms. We proposed the sample size of 200 high-risk pregnancies for the pilot study and quality control of the center to perform the main RCT. We reached this sample size by screening 1686 pregnant women who referred to Maternal- Fetal Hospital Clinic. After taking written conscious consent, from January 2023, the trial with 100 participants in each group started with a ratio of 1:1, randomly.
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
The visit intervals of the participants are montly, up to 28 weeks, every two weeks up to 32 weeks, and weekly up to 36 weeks.
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
1
Description
Incidence of Small for gestational age (<5th centile) requiring delivery at<34 weeks and <37weeks
Timepoint
by performing serial biometrics during pregnancy
Method of measurement
ulrasound
2
Description
Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at≥20 weeks.
Timepoint
by performing serial ultrasound during pregnancy
Method of measurement
ultrasound
3
Description
Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks
Timepoint
routine visits
Method of measurement
history and examination
4
Description
Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity.
Timepoint
after the birth
Method of measurement
examination
5
Description
Admission to Neonate Intensive Care Unit
Timepoint
After the birth
Method of measurement
examination of newborn
6
Description
Incidence of placental abruption (clinically or on placental examination)
Timepoint
at the delivery
Method of measurement
clinical examination
7
Description
Ventilation requirement is defined as the need for positive pressure
Timepoint
after the birth
Method of measurement
clinical examination
8
Description
Neonatal anomaly especially gastroschisis
Timepoint
During the fetal period and at the time of birth
Method of measurement
with ultrasound during pregnancy and postnatal examinations
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
Vali-E-Asr, Imam Khomeini Complex
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