The effect of enoxaparin and aspirin in women with thrombophilia Pierre mutant genes on the incidence of abortion , low birth weight and placental detachment
1-Objectives: The main objective of this study is to determine pregnancy outcome in women with mutant genes thrombophilia
2-Design: 60 women with gestational age of 6 weeks or less that has one or more of the mutant gene that they have least one previous pregnancy that have refered to Al-Zahra hospital in Tabriz, Will be studied
3- Setting and conduct: will be reviewed The women received routine prenatal care during pregnancy and then Will review the abortion;decolman and IUFD
4-Women with 6 weeks gestational and with experienced a previous pregnancy And a mutant gene has been proven in them by PCR.
5- (5) Intervention: LMWH (Clexane) 40 mg subcutaneously every 24 hours and ASA ( aspirin ) will receive 80 mg every 24 hours .
(6) main outcome measures (variables): Primary Outcomes in this study are Detachment of the placenta, low birth weight , preterm birth and abortion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509057676N2
Registration date:2016-01-25, 1394/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Simin Taghavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
taghavisi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of enoxaparin and aspirin in women with thrombophilia Pierre mutant genes on the incidence of abortion , low birth weight and placental detachment
Public title
Pregnancy outcome in women thrombophili mutations
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria :All women with homozygous mutations known thrombophilia and abortion or intrauterine death of two or three times or IUFD.
Exclusion criteria :Anatomical abnormalities of the uterus and fallopian tubes; Diabetes; Hypothyroidism; PCOS; TORCH; Fetal anomalies; Cancel couples to cooperate with investigators and anything that causes a lack of access to the mother
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Ethics Committee Of Tabriz University Of Medical Sciences; Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2015-11-25, 1394/09/04
Ethics committee reference number
TBZMED.REC.1394.733
Health conditions studied
1
Description of health condition studied
Genetic disease
ICD-10 code
O28.5
ICD-10 code description
Abnormal chromosomal and genetic finding on antenatal screening of mother
Primary outcomes
1
Description
Decolman
Timepoint
During pregnancy
Method of measurement
Ultrasound
2
Description
Premature birth
Timepoint
During pregnancy
Method of measurement
Physical examination
3
Description
Abortion
Timepoint
From start to 20 weeks
Method of measurement
Physical examination
4
Description
Full-term birth
Timepoint
During pregnancy
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Case groups : injection of enoxaparin 40 mg subcutaneously every 24 hours.
Category
Treatment - Drugs
2
Description
Case group : ASA( aspirin ) 80 mg orally every 24 hours
Category
Treatment - Drugs
3
Description
Control group: non-use of enoxaparin and aspirin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Simin Taghavi
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Simin Taghavi
Position
Associate Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences; Golgasht Street
City
Tabriz
Postal code
5138665793
Phone
+98 41 3556 9543
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Simin Taghavi
Position
Associate Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences; Golgasht Street
City
Tabriz
Postal code
5138665793
Phone
+98 41 3556 9543
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Simin Taghavi
Position
Associate Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences; Golgasht Street
City
Tabriz
Postal code
5138665793
Phone
+98 41 3556 9543
Fax
Email
lahroudin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)