PreeclampsiaPhase 4METILDOPAPENCT01361425
Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia (Metildopape)
A Phase 4 study testing methildopa in people with Preeclampsia, run by Professor Fernando Figueira Integral Medicine Institute at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- methildopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesBrazil
- Study dates
- May 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- single pregnancy
- severe preeclampsia
- life fetus
- stable blood pressure
- gestational age between 20 weeks and 34 weeks
Who cannot join
- fetal anomalies
- antihypertensive drugs use
- others drugs use
- active labour
- tabagism
- Intra-Uterine Growth Restriction process
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Melania Maria Ramos de Amorim
Campina Grande, João Pessoa
Melania M Amorim, PhD, melamorim@uol.com.br
Carlos N Neto, MD
- Recruiting
Leila Katz
Recife, Pernambuco
Leila Katz, PhD, Katzleila@yahoo.com.br
Carlos N Neto, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- methildopa, placebo
- Keywords
- hypertension, ultrasonography, preeclampsia, clinical trials, treatment, methyldopa
- Medical subject headings
- Pre-Eclampsia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methildopaDrug
Also called ALDOMET
methildopa, 1,5g/day (500mg 8/8 hours, orally)
placeboDrug
Also called Placebo comparator
placebo 500mg 8/8h, orally
| Study group | Role | What they receive |
|---|---|---|
| methildopa | Experimental | pregnant women with stable severe pre-eclampsia will use methildopa (1,5g/day) Receives: Drug: methildopa |
| placebo | Placebo comparator | stable pregnant women with severe preeclampsia will use placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Secondary outcomes (1)
Complications in stable pregnant women with severe preeclampsia after methildopa use
Complications in stable pregnant women with severe preeclampsia after methildopa use
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Melania M Amorim, PHD, Study director, Fernando Figueira IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361425
- Sponsor's protocol ID
- METILDOPA PE 1
- Acronym
- METILDOPAPE
- Status last verified
- Apr 2011
- First submitted
- 24 May 2011
- Last updated
- 30 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia: Randomized Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01361425
- Acronym / sponsor ID
- METILDOPAPE / METILDOPA PE 1
- Conditions
- Preeclampsia
- Keywords
- hypertension, ultrasonography, preeclampsia, clinical trials, treatment, methyldopa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 26 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methildopa | Experimental | Drug: methildopapregnant women with stable severe pre-eclampsia will use methildopa (1,5g/day) |
| placebo | Placebo comparator | Drug: placebostable pregnant women with severe preeclampsia will use placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- single pregnancy
- severe preeclampsia
- life fetus
- stable blood pressure
- gestational age between 20 weeks and 34 weeks
Key exclusion criteria (6 listed)
- fetal anomalies
- antihypertensive drugs use
- others drugs use
- active labour
- tabagism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methildopaAlso: ALDOMETmethildopa, 1,5g/day (500mg 8/8 hours, orally) | Drug | methildopa |
| placeboAlso: Placebo comparatorplacebo 500mg 8/8h, orally | Drug | placebo |
Primary outcome
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.
1 secondary outcome
Complications in stable pregnant women with severe preeclampsia after methildopa use
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melania M Amorim, PHD study director
Fernando Figueira IMIP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methildopa in people with Preeclampsia, run by Professor Fernando Figueira Integral Medicine Institute at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos N Neto, M.S ((81)92340457, ca.no.ne@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood pressure stabilization after methildopa use (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2011.