Protocol summary

Summary
In this double-blinded randomized clinical trial study we would like to compare the effect of high dose (5 mg daily) and low dose (1 mg daily) of folic acid supplementation on prevalence, onset and severity of preeclampsia. nine-hundred pregnant women who are in first trimester with sigelton or twin pregnancy and referred to Shahidbeheshti and Alzahra university hospitals of Isfahan-Iran for two years (10/10/91 and 9/10/93) that not conterasndication of folic acid with satisfaction will include in to the study and if fetal death during the study, major abnormality of the fetus, women who were planning to move outside of the catchment area of the study within the pregnancy duration left study. They are divided randomized computer into two groups of 5mg (treated with daily 5 mg of folic acid) and 1mg (treated with daily 1 mg of folic acid).The first assessment of women was done about complete medical and obstetrical history, physical exam, demographic data (age, weigh, height, BMI and gravidity), calculating gestational age, vital sign (specially systolic and diastolic blood pressure and laboratory data including urine analysis, platelet count, liver function tests (including AST and ALT) and serum's creatinine and making prenatal card. and platelet count will evaluated in a 9-months clinical follow up . The study participants were pregnant women who have received prenatal cares at the study clinics since first visit to delivery for sign of preeclampsia and followed up at least 42 days after child birth in this clinics.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201507313944N4
Registration date: 2015-10-21, 1394/07/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-21, 1394/07/29
Registrant information
Name
Azar Danesh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1627 1631
Email address
danesh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-12-30, 1391/10/10
Expected recruitment end date
2014-12-30, 1393/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of high dose and low dose folic acid supplementation on prevalence, onset and severity of preeclampsia
Public title
High dose folic acid supplementation effect on preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all of women with living fetus in the uterine cavity in first trimester with willingness for participation in this study, were included and do not: Presence or history of a disorder in which administration of folic acid is contraindicated, renal diseases, using anti-epileptic drugs (since the metabolism of anti-epileptic drugs requires a great deal of folic acid), malignancy, alcohol abuse, multiple birth (presence of three living fetus or more) and known hypersensitivity to folic acid (rashes, dermatologic and gastroenterological discomforts). Exclusion criteria: Fetal death during the study, major abnormality of the fetus, women who were planning to move outside of the catchment area of the study within the pregnancy duration.
Age
From 17 years old to 40 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 900
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences committee
Street address
Shahidbeheshti Hospital ,Polfelezi
City
Isfahan
Postal code
8184851153
Approval date
2012-12-30, 1391/10/10
Ethics committee reference number
393587

Health conditions studied

1

Description of health condition studied
Preeclampsia
ICD-10 code
O14.9
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria

Primary outcomes

1

Description
preeclampsia
Timepoint
first visit and routin prenatal care
Method of measurement
measurement blod pressure (mmHg) and proteinuria(mg/dl)

Secondary outcomes

1

Description
incidence of preeclampsia
Timepoint
during pregnancy
Method of measurement
using diagnostic criteria

2

Description
severity of preeclampsia
Timepoint
during pregnancy
Method of measurement
using diagnostic criteria

3

Description
prevalence of preeclampsia
Timepoint
during pregnancy
Method of measurement
using diagnostic criteria

Intervention groups

1

Description
Case group will administered 5 milligrams of folic acid daily from first trimester of pregnancy until termination
Category
Treatment - Drugs

2

Description
case group will receive 1 milligram of folic acid daily from first trimester of pregnancy until termination
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid beheshti Hospital and Alzahra Hospital
Full name of responsible person
Dr Azar Danesh
Street address
Shahidbeheshti Hospital Polfelezi
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Azar Danesh Shahraki
Street address
Shahidbeheshti Hospital,Polfelezi
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Scineces
Full name of responsible person
Dr Azar Danesh
Position
Professor of obstetrics and gynecology
Other areas of specialty/work
Street address
Shahidbeheshti Hospital, Polfelezi
City
Isfahan
Postal code
8184851153
Phone
+98 31 3236 3600
Fax
+98 31 3236 2191
Email
danesh@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical sicnces
Full name of responsible person
Dr Azar Danesh
Position
Professor of obstetrics and gynecology
Other areas of specialty/work
Street address
ShahidBeheshti Hospital ,Polfelezi
City
Isfahan
Postal code
8184851153
Phone
+98 31 3236 2191
Fax
+98 31 3236 3600
Email
danesh@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Nastaran Zamani
Position
resident of gynecology
Other areas of specialty/work
Street address
Shahidbeheshti Hospital Polfelzi
City
Isfahan
Postal code
8184851153
Phone
+98 31 3236 2191
Fax
+98 313393587
Email
Nastaran14zd@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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