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IRCT20221126056611N1 IRCT 2023-01-07 Tehran University of Medical Sciences Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women. Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women. 2023-01-08 anticipated 200 Complete https://irct.ir/trial/67170 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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, 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 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. 3 High Risk Pregnancy for preeclampsia. Intervention 1: 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. Intervention 2: 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). Yes - There is a plan to make this available What will be shared: Final Report & Article When: 6 months after the end of study To whom: Family Health Research Institute Research deputy of University Conditions: As final report and Manuscript Where to obtain: Family Health Research Institute How to obtain: The published article is available to the public. The final report will be provided following the written request Comments:
public Arezoo Behzadian
East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
Tehran Iran (Islamic Republic of) 1487646987 +98 21 4614 1652 dr.behzadian@yahoo.com Tehran University of Medical Sciences scientific Arezoo Behzadian
East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
Tehran Iran (Islamic Republic of) 1487646987 +98 21 4614 1652 dr.behzadian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. no limit no limit Female 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 Z35 Supervision of high-risk pregnancy Prevention Prevention 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. 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). 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). 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. Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at≥20 weeks. Timepoint: by performing serial ultrasound during pregnancy. Method of measurement: ultrasound. Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks. Timepoint: routine visits. Method of measurement: history and examination. Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity. Timepoint: after the birth. Method of measurement: examination. Admission to Neonate Intensive Care Unit. Timepoint: After the birth. Method of measurement: examination of newborn. Incidence of placental abruption (clinically or on placental examination). Timepoint: at the delivery. Method of measurement: clinical examination. Ventilation requirement is defined as the need for positive pressure. Timepoint: after the birth. Method of measurement: clinical examination. 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. Tehran University of Medical Sciences Approved 2022-10-18 Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences KeshavarzBlvd. Tehran Tehran Iran (Islamic Republic of)