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Comparison between L-arginine and aspirin and aspirin alone in preventing preeclampsia in high-risk pregnant women.

Phase 3
Recruiting
Conditions
Condition 1: Preeclampsia. Condition 2: Diabetes Mellitus. Condition 3: Hypertension.
Pre-eclampsia
Diabetes mellitus in pregnancy, childbirth, and the puerperium
Essential (primary) hypertension
Registration Number
IRCT20221108056440N1
Lead Sponsor
Kashan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
90
Inclusion Criteria

Pregnant women who are at high risk for preeclampsia
Pregnant women with a gestational age between 14 and 28 weeks of pregnancy
Previous history of pre-eclampsia in the individual or first degree relatives of the individual's sister or mother
Women with a history of chronic hypertension
Body mass index greater than 30
Multiple pregnancy
Lipid disorders

Exclusion Criteria

Drug sensitivity to L-arginine
Drug sensitivity to aspirin

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Blood Pressure. Timepoint: During the first appointments and at each pregnancy care visit (for visits during pregnancy, it is once a month from the first week to 28 weeks, and every two weeks from 28 to 36 weeks and then weekly examination until the end of pregnancy). Method of measurement: The percentage of people with blood pressure above 90.140 mm Hg.;Preeclampsia. Timepoint: From the 20th week of pregnancy during any pregnancy care as discussed above or if there are any signs and symptoms of preeclampsia from the 20th week onwards. Method of measurement: Checking blood pressure and other signs and symptoms of pre-eclampsia, including headache, blurred vision, chest pain or laboratory disorders such as thrombocytopenia or increased liver enzymes or increased creatinine.
Secondary Outcome Measures
NameTimeMethod
Termination of pregnancy (term or pre-term). Timepoint: At the end of pregnancy. Method of measurement: With the birth of a baby and during childbirth.;IUGR. Timepoint: During pregnancy care, especially during the 28th till 32nd weeks and at the time of birth. Method of measurement: Measurement of fetal weight and growth during pregnancy and birth weight.;Pregnancy complication. Timepoint: During pregnancy and childbirth. Method of measurement: Examination in terms of the amount of bleeding, meconium, decollement, stillbirth, preterm labour.
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