MedDataX Logo

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

NCT ID: NCT01361425

Last Updated: 2011-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preeclampsia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hypertension ultrasonography preeclampsia clinical trials treatment methyldopa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

methildopa

pregnant women with stable severe pre-eclampsia will use methildopa (1,5g/day)

Group Type EXPERIMENTAL

methildopa

Intervention Type DRUG

methildopa, 1,5g/day (500mg 8/8 hours, orally)

placebo

stable pregnant women with severe preeclampsia will use placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo 500mg 8/8h, orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

methildopa

methildopa, 1,5g/day (500mg 8/8 hours, orally)

Intervention Type DRUG

placebo

placebo 500mg 8/8h, orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ALDOMET Placebo comparator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Professor Fernando Figueira Integral Medicine Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

IMIP

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melania M Amorim, PHD

Role: STUDY_DIRECTOR

Fernando Figueira IMIP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Melania Maria Ramos de Amorim

Campina Grande, João Pessoa, Brazil

Site Status RECRUITING

Leila Katz

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carlos N Neto, M.S

Role: CONTACT

Phone: (81)92340457

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Melania M Amorim, PhD

Role: primary

Leila Katz, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

METILDOPA PE 1

Identifier Type: -

Identifier Source: org_study_id