it is A double-blind, randomized, study is doing to evaluate the efficacy of i.v. immunoglobulin in the prevention of reccurent abortion in patient with reccurent abortion in emam khomini hospital in sari 2012. The study was approved by the Local Ethics Committee. inclusion criteria: pregnant women with reccurent abortion ( was defined as two or more consecutive fetal losses before the 20th gestational week). exclusion criteria: other couse for abortion such as structural and anatomical disorder; Abnormal result of chromosomal analysis of the couple; using anti coagulant in pregnancy; aspirin sensivity; hypertention; peptic ulcer. We examined 68 women with recurrent abortion. The subjects were randomly assigned to treatment with low molcular weight heparin 40 mg daily until 24th week plus low-dose aspirin 80mg daily until 37th week and in other group IVIG 200mg/kg until 24th week with LMWH and aspirin as the same regimn. Both therapies were started when the women were pregnant as documented by a positive urine test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012081210568N1
Registration date:2013-03-16, 1391/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-16, 1391/12/26
Registrant information
Name
Zinab Nazari
Name of organization / entity
University of Medical Sciences Mazandaran
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 2717
Email address
zinabnazari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-07-01, 1390/04/10
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adding intravenous immunoglobulin to heparin and aspirin regiment for prevention of reccurent abortion
Public title
Effect of adding intravenous immunoglobulin to heparin and aspirin regiment for prevention of reccurent abortion
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: pregnant women with reccurent abortion ( was defined as two or more consecutive fetal losses before the 20th gestational week). exclusion criteria: other couse for abortion such as structural and anatomical disorder; Abnormal result of chromosomal analysis of the couple; using anti coagulant in pregnancy; aspirin sensivity; hypertention; peptic ulcer.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
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
Mazandaran University of Medical Sciences
Street address
Moallem Square
City
Sari
Postal code
98
Approval date
2011-05-22, 1390/03/01
Ethics committee reference number
90-22
Health conditions studied
1
Description of health condition studied
Recurrent Abortion
ICD-10 code
Pregnancy,
ICD-10 code description
Pregnancy with abortive outcome
Primary outcomes
1
Description
recurrent abortion
Timepoint
4th month after intervention
Method of measurement
physical examination
Secondary outcomes
1
Description
continue of pregnancy
Timepoint
when pregnancy terminat
Method of measurement
physical exam
Intervention groups
1
Description
in control group treatment is Low Molcular Weight Heparin(noxaparin) 40 mg daily sub cotaneus for 24 weeks And Aspirin 80 mg daily for 37 weeks.
Category
Treatment - Drugs
2
Description
case group treat with IVIG 200 mg/kg mounthly for 24 weeks and Low Molcular Weight Heparin(noxaparin) 40 mg daily sub cotaneus for 24 weeks And Aspirin 80 mg daily for 37 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Dr Zinab Nazari
Street address
Emam khomeini Hospital- Razi Street
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
dr zinab nazari
Street address
Emam khomeini Hospital
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
dr zinab nazari
Position
Gynecologist-1. Department of Obstetrics and Gynecology, Medical School
Other areas of specialty/work
Street address
Emam khomeini Hospitali
City
Sari
Postal code
Phone
+98 15 1225 2845
Fax
Email
zinabnazari@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Zinab Nazari
Position
1. Department of Obstetrics and Gynecology, Medical School
Other areas of specialty/work
Street address
Emam khomeini Hospital
City
Sari
Postal code
Phone
+98 15 1225 2845
Fax
Email
zinabnazari@mazums.ac.irdr.jamkhane@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Aghdas Ebadi
Position
Obstetrics Resident
Other areas of specialty/work
Street address
Emam khomeini Hospital
City
Sari
Postal code
Phone
+1 512252845
Fax
Email
dr.jamkhane@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)