Preeclampsia
Conditions
Keywords
L arginine, Preeclampsia
Brief summary
Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia. applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes
Detailed description
Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo. Each three weeks were evaluated in search of high blood pressure and proteinuria. The follow-up was until the end of pregnancy and two weeks after this
Interventions
DIETARY_SUPPLEMENTL arginine
L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.
OTHERPlacebo
calcined magnesia
Sponsors
Hospital Civil Juan I. Menchaca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)
Exclusion criteria
* pregnant women carriers of chronic renal failure * pre gestational diabetes * multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of L arginine to prevent preeclampsia | from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks. | number of patients with diagnosis of preeclampsia. the diagnostic was performed when they presented arterial blood pressure above 140/90 mm / Hg in the span of 6 hours and accompanied by proteinuria (\>300 milligrams in one sample) number of patients with high blood pression and proteinuria (ACOG criteria) The evaluations were performed every three weeks until week 31, then every two weeks until week 35 and weekly until pregnancy ended |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| perinatal outcome | from time to delivery until two weeks after, approximalety 18 weeks | number of patients with adverse perinatal outcome: APGAR scale \< 7 at five minutes, low weight for gestational age (\< 10 percentile) and CAPURRO scale \< 37 weeks also the need to enter the neonatal intensive care unit |
| safety of L arginine | from time of randomization until birth approximalety 18 weeks | number of patients with adverse reactions and/or any alteration of blood test. participants are awarded a diary which recorded the symptoms that caused them any discomfort. If the discomfort was important it was reported via telephone with the treating physician. the paper was reviewed at each appointment. Blood tests such as blood count, liver function tests and kidney were performed every three weeks in search of alterations in the parameters considered normal by those tests (ACOG criteria) |
Countries
Mexico
Outcome results
None listed