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

NCT01361425 | Unknown Phase 4 DMC

• 1 other identifier: METILDOPA PE 1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Preeclampsia

Keywords

hypertension; ultrasonography; preeclampsia; clinical trials; treatment; methyldopa

Outcome Measures

Primary Outcomes (1)

• Arterial blood pressure stabilization after methildopa use

  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 Outcomes (1)

• Complications in stable pregnant women with severe preeclampsia after methildopa use

  one week

Study Arms (2)

methildopa

EXPERIMENTAL

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

Drug: methildopa

placebo

PLACEBO COMPARATOR

stable pregnant women with severe preeclampsia will use placebo

Drug: placebo

Interventions

methildopa DRUG

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

Also known as: ALDOMET

methildopa

placebo DRUG

placebo 500mg 8/8h, orally

Also known as: Placebo comparator

placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• single pregnancy
• severe preeclampsia
• life fetus
• stable blood pressure
• gestational age between 20 weeks and 34 weeks

You may not qualify if:

• fetal anomalies
• antihypertensive drugs use
• others drugs use
• active labour
• tabagism
• Intra-Uterine Growth Restriction process

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (2)

Melania Maria Ramos de Amorim

Campina Grande, João Pessoa, Brazil

RECRUITING

Leila Katz

Recife, Pernambuco, Brazil

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Interventions

Methyldopa

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Melania M Amorim, PHD

  Fernando Figueira IMIP

  STUDY DIRECTOR

Central Study Contacts

Carlos N Neto, M.S

CONTACT

(81)92340457; ca.no.ne@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 26, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 30, 2011

Record last verified: 2011-04

Locations

BR (2)