Abortion is a common and inevitable event and also major cause of anxiety for a couple while trying pregnancy. There is no certain therapeutic regimen to overcome abortion complete. Here we investigated the success rate of low-dose IVIG in comparison with aspirin usage in the treatment of recurrent miscarriage.
This clinical trial study consisted of 50 women referred to Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran. The cases were randomly divided into two groups of 25 individuals. Aspirin (80 mg) was administered daily to the control group, while in the study group 5 g IVIG was administered in 8 doses: once before pregnancy and then monthly for up to 32 weeks of gestation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021220993N2
Registration date:2015-03-11, 1393/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-11, 1393/12/20
Registrant information
Name
Majid Jafari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2770
Email address
jafarim912@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research in Mashhad University of Medical Sciences
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2009-03-20, 1387/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Low-Dose Intravenous Immunoglobulin decrease rate of Immunologic Abortion; a clinical trial
Public title
Intravenous Immunoglobulin decrease rate of Immunologic Abortion
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: women with at least two abortions that had taken place naturally or with assisted reproductive techniques (ART) and who had at least one positive immunologic test for anti-cardiolipin; anti-phospholipid antibodies;anti-thyroid antibody; anti-nuclear antibody;Anti-sperm antibody.
Exclusion criteria: anatomical problems; infections; hormonal factors contributing to recurrent abortion and parental factors were excluded.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Regional ethics committee in Mashhad University of Medical Sciences
Supervision of pregnancy with history of abortive outcome
Primary outcomes
1
Description
neonate
Timepoint
9 month
Method of measurement
Delivery
Secondary outcomes
1
Description
Abortion
Timepoint
Each time after intervention
Method of measurement
exposing symptoms of abortion
2
Description
premature birth
Timepoint
Each time after intervention
Method of measurement
exposing symptoms of premature birth
Intervention groups
1
Description
Aspirin (80 mg) was administered daily to the control group
Category
Treatment - Drugs
2
Description
the study group 5 g IVIG was initiated within 2 weeks prior to attempted conception. After conception occurred, IVIG was given every 4 weeks for up to 32 weeks of gestation. IVIG was administered in hospital through vein perfusion during a 3-6 hour period and clinical signs and symptoms were controlled under the supervision of a clinical allergy and immunology fellowship resident."
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Majid jafari fellowship of allergy and clinical immunology
Street address
allergy and clinical immunology ward, Ghaem Hospital
City
Mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research in Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saieed Eslami
Street address
Research Managment, Ghoreieshi Building, daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research in Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
majid jafari
Position
fellowship
Other areas of specialty/work
Street address
allergy and clinical immunology ward,Ghaem Hospital
City
mashhad
Postal code
9176699199
Phone
+98 51 3801 2770
Fax
+98 51 3842 2544
Email
jafarim912@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
majid jafari
Position
fellowship
Other areas of specialty/work
Street address
allergy and clinical immunology ward, Ghaem Hospital
City
mashhad
Postal code
9176699199
Phone
+98 51 3801 2770
Fax
+98 51 3842 2544
Email
jafarim912@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
majid jafari
Position
fellowship
Other areas of specialty/work
Street address
allergy and clinical immunology ward, Ghaem Hospital
City
Mashhad
Postal code
9176699199
Phone
+98 51 3801 2770
Fax
+98 51 3842 2544
Email
jafarim912@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)