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Trial record 5 of 16 for:    Methyldopate hydrochloride

Effect of Methyldopa on Uterine Artery Diameter in Pregnant Women With Mild Preeclampsia

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ClinicalTrials.gov Identifier: NCT01674127
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : August 28, 2012
Sponsor:
Information provided by (Responsible Party):
Mojtaba Akbari, Isfahan University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnant Women With Mild Preeclampsia Drug: Methyldopa Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : May 2012


Arm Intervention/treatment
Experimental: Methyldopa
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.
Drug: Methyldopa
Placebo Comparator: placebo Drug: Placebo



Primary Outcome Measures :
  1. 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".




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
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).

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Responsible Party: Mojtaba Akbari, , Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01674127     History of Changes
Other Study ID Numbers: 390306
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
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Methyldopa
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action