NCT01674127

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

August 24, 2012

Last Update Submit

August 27, 2012

Conditions

Pregnant Women With Mild Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Drug: Methyldopa

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MethyldopaDRUG
Methyldopa
PlaceboDRUG
placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Methyldopa

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR

Study Record Dates

First Submitted

August 24, 2012

First Posted

August 28, 2012

Study Start

August 1, 2011

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

August 28, 2012

Record last verified: 2012-08