Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia (Metildopape)
Information source: Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preeclampsia
Intervention: methildopa (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Professor Fernando Figueira Integral Medicine Institute Official(s) and/or principal investigator(s): Melania M Amorim, PHD, Study Director, Affiliation: Fernando Figueira IMIP
Overall contact: Carlos N Neto, M.S, Phone: (81)92340457, Email: ca.no.ne@hotmail.com
Summary
Introduction: Hypertensive emergency in pregnant women with pre-eclampsia should be treated
for preventing stroke and placental abruption. However, the benefit of antihypertensive
medication maintenance remains unclear, mainly due to the potential risk of fetal growth
restriction.
Clinical Details
Official title: Effectiveness Of Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia: Randomized Placebo-Controlled Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Arterial blood pressure stabilization after methildopa use
Secondary outcome: Complications in stable pregnant women with severe preeclampsia after methildopa use
Detailed description:
Objectives: To evaluate the effectiveness of antihypertensive treatment maintenance with 1. 5
g / day of methyldopa for controlling maternal blood pressure in pregnant women with severe
pre-eclampsia and stable blood pressure. Methods: A clinical, randomized, triple-masked,
placebo-controlled study will be conducted at the Instituto de Medicina Integral Prof.
Fernando Figueira from March 2011 to March 2012. The study will include 200 patients with
severe preeclampsia between 20 to 34 weeks of gestation, which will be randomized into two
groups: placebo and methyldopa. Patients with more severe hypertensive disorders, congenital
anomalies and maternal medical complications or conditions that may compromise the
mother-child well-being will be excluded from the study. The primary outcomes will be:
systolic, diastolic and mean maternal heart rate, need for association with another
antihypertensive agent, need and reason for discontinuation of treatment, frequency of
hypertensive peaks and uncontrolled hypertension. The variables relating to maternal
characteristics of pregnancy, clinical and obstetric complications during pregnancy and
after delivery, and adverse perinatal outcomes will be considered secondary outcomes. After
inclusion of patients in the study, numbered boxes containing methyldopa or placebo will be
offered to patients with appropriate explanations about oral administration. The initial
dose of methyldopa is 1. 5 g / day divided into three daily doses and can be reduced to 1. 0 g
/ day or increased to 2. 0 g / day depending on the clinical need of patients. On the other
group, three tablets / day of placebo will be administered and this dose may be reduced or
increased to two tablets to four tablets per day. Statistical analysis will be performed
using the statistical program Epi-Info 3. 5.1. and Minitab, version 14. 2. for Windows. The
analysis will be performed with the groups identified as A or B, and the secrecy will be
broken only after obtaining the results and preparing the tables or by resolution of the
Committee for External Monitoring. Categorical variables will be compared in contingency
tables, using chi-square and Fisher exact test, when appropriate. Risk ratio (RR) and its
95% confidence interval will be calculated as a measure of relative risk. Regarding the
quantitative variables, if they have normal distribution, comparison between groups will be
performed using the Student t test for unpaired samples. If it is found that the
distribution is not normal, the nonparametric Mann-Whitney test will be used.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- single pregnancy
- severe preeclampsia
- life fetus
- stable blood pressure
- gestational age between 20 weeks and 34 weeks
Exclusion Criteria:
- fetal anomalies
- antihypertensive drugs use
- others drugs use
- active labour
- tabagism
- Intra-Uterine Growth Restriction process
Locations and Contacts
Carlos N Neto, M.S, Phone: (81)92340457, Email: ca.no.ne@hotmail.com
Melania Maria Ramos de Amorim, Campina Grande, João Pessoa, Brazil; Recruiting Melania M Amorim, PhD, Email: melamorim@uol.com.br Carlos N Neto, MD, Principal Investigator
Leila Katz, Recife, Pernambuco, Brazil; Recruiting Leila Katz, PhD, Email: Katzleila@yahoo.com.br Carlos N Neto, MD, Principal Investigator
Additional Information
Starting date: May 2011
Last updated: May 27, 2011
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