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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier:
NCT01361425
First received: May 24, 2011
Last updated: May 27, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Preeclampsia
Drug: methildopa
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness Of Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia: Randomized Placebo-Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Professor Fernando Figueira Integral Medicine Institute:

Primary Outcome Measures:
  • Arterial blood pressure stabilization after methildopa use [ Time Frame: one week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Complications in stable pregnant women with severe preeclampsia after methildopa use [ Time Frame: one week ] [ Designated as safety issue: No ]
    Complications in stable pregnant women with severe preeclampsia after methildopa use


Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ALDOMET
Placebo Comparator: placebo
stable pregnant women with severe preeclampsia will use placebo
Drug: placebo
placebo 500mg 8/8h, orally
Other Name: Placebo comparator

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361425

Contacts
Contact: Carlos N Neto, M.S (81)92340457 ca.no.ne@hotmail.com

Locations
Brazil
Melania Maria Ramos de Amorim Recruiting
Campina Grande, João Pessoa, Brazil
Contact: Melania M Amorim, PhD       melamorim@uol.com.br   
Principal Investigator: Carlos N Neto, MD         
Leila Katz Recruiting
Recife, Pernambuco, Brazil
Contact: Leila Katz, PhD       Katzleila@yahoo.com.br   
Principal Investigator: Carlos N Neto, MD         
Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Melania M Amorim, PHD Fernando Figueira IMIP
  More Information

No publications provided

Responsible Party: M.D; M.S Carlos Noronha Neto, IMIP
ClinicalTrials.gov Identifier: NCT01361425     History of Changes
Other Study ID Numbers: METILDOPA PE 1
Study First Received: May 24, 2011
Last Updated: May 27, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Professor Fernando Figueira Integral Medicine Institute:
hypertension
ultrasonography
preeclampsia
clinical trials
treatment
methyldopa

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014