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

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01674127

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Doppler indices [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Isfahan University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mojtaba Akbari, , Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01674127

Other Study ID Numbers:

390306

First Posted:

Aug 28, 2012

Last Update Posted:

Aug 28, 2012

Last Verified:

Aug 1, 2012

Additional relevant MeSH terms:

Pre-Eclampsia

Methyldopa

Study Results

No Results Posted as of Aug 28, 2012