Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia (Metildopape) (METILDOPAPE)

May 27, 2011 updated by: Professor Fernando Figueira Integral Medicine Institute

Effectiveness Of Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia: Randomized Placebo-Controlled Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • João Pessoa
      • Campina Grande, João Pessoa, Brazil
        • Recruiting
        • Melania Maria Ramos de Amorim
        • Contact:
        • Principal Investigator:
          • Carlos N Neto, MD
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Recruiting
        • Leila Katz
        • Principal Investigator:
          • Carlos N Neto, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: methildopa
pregnant women with stable severe pre-eclampsia will use methildopa (1,5g/day)
Drug: methildopa
methildopa, 1,5g/day (500mg 8/8 hours, orally)
Other Names:
  • ALDOMET
PLACEBO_COMPARATOR: placebo
stable pregnant women with severe preeclampsia will use placebo
Drug: placebo
placebo 500mg 8/8h, orally
Other Names:
  • Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood pressure stabilization after methildopa use
Time Frame: one week
Stabilization of arterial blood pressure in stable pregnant women with severe pre-eclampsia after methildpa or placebo use will be investigated, as well as occurrence of complications for mother and fetus.
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications in stable pregnant women with severe preeclampsia after methildopa use
Time Frame: one week
Complications in stable pregnant women with severe preeclampsia after methildopa use
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Fernando Figueira Integral Medicine Institute

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Study Director: Melania M Amorim, PHD, Fernando Figueira IMIP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2012

Study Completion (ANTICIPATED)

February 1, 2013

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (ESTIMATE)

May 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2011

Last Update Submitted That Met QC Criteria

May 27, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METILDOPA PE 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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