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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01674127
Other study ID # 390306
Secondary ID
Status Completed
Phase Phase 2
First received August 24, 2012
Last updated August 27, 2012
Start date August 2011
Est. completion date May 2012

Study information

Verified date August 2012
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Methyldopa

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary 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".
7 days Yes