The purpose of this study was to evaluate the efficacy of low molecular weight heparin (LMWH) and Aspirin (ASA) on the patients with unexplained recurrent spontaneous abortions (URSA). A total of 100 patients with a history of URSA referring to obstetrics clinic in Shiraz University affiliated hospitals were randomized into two groups. Fifty patients received LMWH (fragmin 5000 unit, subcutaneously, twice a day) as well as ASA 80 mg daily. Another fifty patients received no thromboprophylaxis. Live birth rate, obstetrical complications, prenatal and neonatal complications, and hemorrhagic side effects were recorded and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811073215N1
Registration date:2010-05-26, 1389/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-26, 1389/03/05
Registrant information
Name
Fatemeh Ahmadpour
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
ahmadpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research committee of Shiraz University of Medical Sciences
Expected recruitment start date
2008-10-07, 1387/07/16
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of aspirin and low molecular weight heparin in patients with unexplained recurrent spontaneous abortions.
Public title
The impact of combination thromboprophylaxis on patients with unexplained recurrent spontaneous abortions.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Incidence of at least 3 consecutive recurrent abortions
Exclusion criteria: known cause of recurrent abortion, abnorml TFT, FBS, or FSH (3rd day of cycle), uterine anomaly, positive antiphospholipid Ab or anticardiolipin Ab, presence of thrombophilia, abnormal karyotype of both couples
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Research Ethics of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical sciences, Zand blvd, Nemazi square-beside of Red Crescent-
City
Shiraz
Postal code
71348-14336
Approval date
2008-06-08, 1387/03/19
Ethics committee reference number
87-416
Health conditions studied
1
Description of health condition studied
pregnancy rate beyond 20 weeks of gestational age in habitual aborters
ICD-10 code
O26.2
ICD-10 code description
Pregnancy care of habitual abortor
Primary outcomes
1
Description
continuation of pregnancy beyond 20 weeks of pregnancy
Timepoint
20 weeks after last menstural period
Method of measurement
alive fetus by ob sonography or hearing fetal heart by sonocate or fetoscope
Secondary outcomes
1
Description
live birth rate
Timepoint
after delivery
Method of measurement
live fetus delivery after 28 weeks of gestational age
Intervention groups
1
Description
Low Molecular Weight Heparin, 5000 unit subcutaneous twice a day and Asprin 80 mg po daily till 36 weeks of pregnancy or any premature sign of preterm delivery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers affiliated to the obstetric's department of Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadpour
Street address
Zand street,Shahid Faghihi Hospital,Department of ob&gyn
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice canceller for research of Shiraz University of Medical Siences
Full name of responsible person
Dr.Mohammad Hossein Dabaghmanesh
Street address
Zand street-beside red crescent department
City
Shiraz
Grant name
87-4163
Grant code / Reference number
ct-87-4163
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice canceller for research of Shiraz University of Medical Siences
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
Department of ob&gyn
Full name of responsible person
Fatemeh Ahmadpour
Position
Resident of ob & gyn/ MD.
Other areas of specialty/work
Street address
Department of ob&gyn, Faghihi Hospital,Imam Hossein Square, Zand street,
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
+98 71 1233 2365
Email
ahmadpour@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of ob&gyn
Full name of responsible person
Jaleh Zolghadri
Position
Associate Professor of ob & gyn
Other areas of specialty/work
Street address
Department of ob&gyn, Faghihi Hospital,Imam Hossein Square, Zand street,
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
+98 71 1233 2365
Email
zolghadj@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of ob&gyn
Full name of responsible person
Jaleh Zolghadri
Position
Associate Professor of ob&gyn
Other areas of specialty/work
Street address
Department of ob&gyn, Faghihi Hospital,Imam Hossein Square, Zand street,
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
+98 71 1233 2365
Email
zolghadj@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)