Pregnant Women With Mild PreeclampsiaPhase 2NCT01674127
Effect of Methyldopa on Uterine Artery Diameter in Pregnant Women With Mild Preeclampsia
A Phase 2 study testing Methyldopa in people with Pregnant Women With Mild Preeclampsia, run by Isfahan University of Medical Sciences.
Trial summary
The present study examined the effects of Methyldopa on uterine artery diameter, uterine artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with Preeclampsia, using Doppler ultrasound. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnant Women With Mild Preeclampsia
- What is being tested?
- Methyldopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to May 2012
- Phase
- Phase 2
- 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
- No healthy volunteers
- Child, Adult, Older adult
They met the inclusion criteria, If they had over 25 weeks of gestational age, no history of chronic hypertension, no diabetes mellitus, no chronic systemic diseases, no collagen vascular diseases and antiphospholipid syndromes, no use of antihypertensive drugs and BMI higher than 19 and lower than 30 (kg/m2).
About this study
The present study examined the effects of Methyldopa on uterine artery diameter, uterine artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with Preeclampsia, using Doppler ultrasound.
- Conditions
- Pregnant Women With Mild Preeclampsia
- Being tested
- Methyldopa, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethyldopaDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Methyldopa | Experimental | In case group, 25 patients, under treatment, using Methyldopa for 7 days, received 500 mgs of Methyldopa in its oral form per day and in control group, participants received placebo for 7 days. Receives: Drug: Methyldopa |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler indices
In case group, 25 patients, under treatment, using Methyldopa for 7 days, received 500 mgs of Methyldopa in its oral form per day and in control group, participants received placebo for 7 days.Before and after drug use, Doppler ultrasound test was done by a radiology specialist not informed of patients grouping. Also, pulsatility index, resistance index, systolic/diastolic blood flow ratios of uterine artery, umbilical artery and middle-cerebral artery were evaluated. Registered for all patients, age, BMI, gestational week and the number of pregnancies were among other examined variables.
Doppler indices of examined arteries in studied groups were evaluated by color Doppler ultrasound of model "Hitachi 3/6 MHz".
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women With Mild 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mojtaba Akbari, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674127
- Sponsor's protocol ID
- 390306
- Status last verified
- Aug 2012
- First submitted
- 24 Aug 2012
- Last updated
- 28 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Methyldopa on Uterine Artery Diameter in Pregnant Women With Mild Preeclampsia
- ClinicalTrials.gov ID
- NCT01674127
- Acronym / sponsor ID
- 390306
- Conditions
- Pregnant Women With Mild Preeclampsia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 28 Aug 2012 (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.
The present study examined the effects of Methyldopa on uterine artery diameter, uterine artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with Preeclampsia, using Doppler ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methyldopa | Experimental | Drug: MethyldopaIn case group, 25 patients, under treatment, using Methyldopa for 7 days, received 500 mgs of Methyldopa in its oral form per day and in control group, participants received placebo for 7 days. |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Methyldopa | Drug | Methyldopa |
| Placebo | Drug | placebo |
Primary outcome
Doppler indices
Time frame: 7 days
In case group, 25 patients, under treatment, using Methyldopa for 7 days, received 500 mgs of Methyldopa in its oral form per day and in control group, participants received placebo for 7 days.Before and after drug use, Doppler ultrasound test was done by a radiology specialist not informed of patients grouping. Also, pulsatility index, resistance index, systolic/diastolic blood flow ratios of uterine artery, umbilical artery and middle-cerebral artery were evaluated. Registered for all patients, age, BMI, gestational week and the number of pregnancies were among other examined variables. Doppler indices of examined arteries in studied groups were evaluated by color Doppler ultrasound of model "Hitachi 3/6 MHz".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methyldopa in people with Pregnant Women With Mild Preeclampsia, run by Isfahan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler indices (time frame: 7 days). 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 28 Aug 2012.