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

Determining the effect of metformin in the prevention of preeclampsia in high-risk pregnancies Determining the effect of metformin during pregnancy in preeclampsia in high-risk pregnancies

Eligible subjects were randomly divided into two groups: the control group (A) received 150 mg aspirin from weeks 12 to 20, and the intervention group (B) received 500 mg metformin twice daily in addition to 150 mg aspirin from weeks 12 to 20. It should be noted that the patient and the assessor were unaware of the group assignment and the study was double-blind

Eligible subjects were randomly divided into two groups: the control group received 150 mg aspirin from weeks 12 to 20, and the intervention group received 500 mg metformin twice daily from weeks 12 to 20 in addition to 150 mg aspirin. The patients and the assessor were unaware of the group assignment, and the study was double-blind

Inclusion criteria: 1- Pregnant mothers aged 18 to 45 years - Gestational age 12 to 20 weeks 2- Mothers who are at moderate or high risk for preeclampsia according to the ACOG risk assessment table 3- Serum PAPP-A marker level at 12 weeks screening is less than 0.5 MOM 4- Mean bilateral uterine artery resistance index (PI) is greater than the 95th percentile for gestational age, on NT sonography (12 minutes) or anomalous scan ultrasound at 18 to 19 weeks. Exclusion criteria: 1- Sensitivity to metformin - Maternal unwillingness to take the drug 2- Major abnormality in anomalous scan 3- Abnormal karyotype in CVS (chorionic villus sampling) or amniocentesis

Intervention group (B) In addition to 150 mg of aspirin, metformin 500 mg twice daily starting from weeks 12 to 20

Severe manifestations such as severe headaches, nausea and vomiting, and visual symptoms, and in the case of high blood pressure

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

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

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