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-eclampsiaDiabetes mellitus in pregnancy, childbirth, and the puerperiumEssential (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
Name Time Method 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
Name Time Method 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.