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

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ClinicalTrials.gov Identifier: NCT01361425
Recruitment Status : Unknown
Verified April 2011 by Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was:  Recruiting
First Posted : May 26, 2011
Last Update Posted : May 30, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: methildopa Drug: placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness Of Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia: Randomized Placebo-Controlled Clinical Trial
Study Start Date : May 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361425

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

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
Study Director: Melania M Amorim, PHD Fernando Figueira IMIP
More Information

Responsible Party: M.D; M.S Carlos Noronha Neto, IMIP
ClinicalTrials.gov Identifier: NCT01361425     History of Changes
Other Study ID Numbers: METILDOPA PE 1
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: April 2011

Keywords provided by Professor Fernando Figueira Integral Medicine Institute:
clinical trials

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antihypertensive Agents