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IRCT20251031067831N1 IRCT 2026-02-16 Yasouj University of Medical Sciences Investigating the effect of Metformin and Aspirin on the prevention of Preeclampsia Investigating the effect of Metformin and Aspirin compared to Aspirin on the prevention of Preeclampsia and the duration of pregnancy and some maternal and neonatal outcomes 2025-12-15 anticipated 146 Complete https://irct.ir/trial/87317 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Prevention, Randomization description: The blocking method will be used to allocate mothers to two groups. The advantages of blocked randomization are that it ensures a balance in the number of patients in each group. The groups are defined as codes B and A. Group A will be considered the intervention and group B the control. Before assigning individuals to one of the groups, a list of letters (B, A) is formed, called blocks. Each of the referring and eligible individuals will be assigned to one of the groups according to the created list. To avoid the risk of predicting the assignment of individuals to different groups, blocks of different sizes will be created. Blocks of two such as AB - blocks of four such as ABAB - blocks of six such as AABABB - blocks of eight such as ABBABABA, Blinding description: The drugs are coded according to the label A and B and are given to the intervention and control groups in such a way that the identity of the drug is not known to the patient. In order to blind the patients, both groups are given pregnancy supplements. The assessor who checks and measures the variables is faced with the label A and B and knows which drug each patient is taking. The pregnant mothers are not aware of being in the intervention or control group and are only divided into two groups A and B. 1-2 Preeclampsia. Intervention group: Metformin receiving group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Sima Ghobadi
Imam Sajjad
Yasuj Iran (Islamic Republic of) 7591961319 +98 74 3222 0163 ahmadimche@gmail.com Yasouj University of Medical Sciences scientific Sima Ghobadi
Yasuj, Shahid Motahari Blvd., Yasuj University of Medical Sciences Headquarters
Yasuj Iran (Islamic Republic of) 7591994759 +98 74 3322 0164 ahmadimche@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers aged 18 to 45 years - gestational age 12 to 20 weeks Mothers who are at moderate or high risk for preeclampsia according to the ACOG risk assessment table Serum PAPP-A marker level at 12 weeks screening is less than 0.5 MOM Mean bilateral uterine artery resistance index (PI) is greater than the 95th percentile for gestational age, on NT sonography (12 minutes) or anomalous ultrasound scan at 18 to 19 weeks. 18 years 45 years Female Sensitivity to metformin - maternal lack of consent to taking the medication Major abnormality in anomalous scan Abnormal karyotype on CVS (chorionic villus sampling) or amniocentesis Prevention Intervention group: Metformin receiving group Preventing preeclampsia in high-risk mothers. Timepoint: Once every two weeks. Method of measurement: Questionnaire and data collection form. Yasouj University of Medical Sciences Approved 2025-05-03 Ethics Committee of Yasuj University of Medical Sciences Yasuj, Shahid Motahari Boulevard Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)