To investigate the association between thrombophilia and unexplained recurrent miscarriage (RM) and to evaluate the efficacy of anticoagulant treatment.
In this quasi experimental, we enrolled 520 women, who had a history of recurrent miscarriage, which 252 women with unexplained recurrent miscarriage were assigned in this study. Women with chromosomal abnormalities, uterin and cervical anatomical problem, disturb ovarian and hormonal function were excuded from this study. One group received aspirin (80mg daily) for two months before pregnancy and after confirmation of a viable pregnancy until 36 weeks of gestation, and other group received aspirin, as the same, plus heparin (5000unit twice a day) subcutaneously after confirmation of viable pregnancy until 4 weeks after delivery. Type of medication was chosen for each woman according to number of abortion and age.
Effectiveness of treatments were evaluated by pregnancy rate till 20 weeks and normal child delivery.
Inclusion criteria: unexplained recurrent pregnancy loss; women with thrombophilia exclusion criteria: abnormal karyotypes of each partner; uterine; cervical anatomical disorders on pelvic ultrasonography; hysteroscopy; abnormal ovaries function; abnormal endocrine tests; and antiphospholipid syndrome
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102315123N1
Registration date:2013-12-24, 1392/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-24, 1392/10/03
Registrant information
Name
Nasrin Ghasemi
Name of organization / entity
Research & Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
ghasemi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Clinical Center for infertility, Yazd, Iran
Expected recruitment start date
2010-10-01, 1389/07/09
Expected recruitment end date
2012-10-01, 1391/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of aspirin in compare with heparin plus aspirin in recurrent pregnancy loss treatment
Public title
Aspirin and heparin in recurrent pregnancy loss treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: unexplained recurrent pregnancy loss; women with thrombophilia exclusion criteria: abnormal karyotypes of each partner; uterine; cervical anatomical disorders on pelvic ultrasonography; hysteroscopy; abnormal ovaries function; abnormal endocrine tests; and antiphospholipid syndrome
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
252
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd,
Street address
Bouali Ave, Safaeyeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Approval date
2013-01-16, 1391/10/27
Ethics committee reference number
2460
Health conditions studied
1
Description of health condition studied
recurrent pregnancy loss
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion
Primary outcomes
1
Description
pregnancy after 20 weeks
Timepoint
after 20 weeks
Method of measurement
Sonography
Secondary outcomes
1
Description
Live-birth rates
Timepoint
2 weeks after intervention
Method of measurement
mesearment of blood beta hCG
Intervention groups
1
Description
Intervention: aspirin, 80mg, daily, two month before pregnancy and after pregnancy until 36 weeks of gestation, plus heparin, 5000unit twice a day after pregnancy until 4 weeks after delivery
Category
Treatment - Drugs
2
Description
Control: aspirin orally, 80mg, daily for two month before pregnancy and afte pregnancy until 36 weeks of gestation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Yazd, Iran
Full name of responsible person
Nasrin Ghasemi
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Clinical Center for Infertility,Yazd, Iran
Full name of responsible person
Alimohammad Abdoli
Street address
Bouali Ave, Safaeyeh, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Clinical Center for Infertility,Yazd, Iran
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
Research and Clinical Center for Infertility, Yazd, Iran
Full name of responsible person
Nasrin Ghasemi
Position
PhD/Faculty remember
Other areas of specialty/work
Street address
Buali Ave, Safaeyeh, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1824 8122
Fax
Email
ghasemi@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Yazd, Iran
Full name of responsible person
Nasrin Ghasemi
Position
Genetics Molecular Biology PhD
Other areas of specialty/work
Street address
Bouali Ave, Safaeyeh, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1824 8122
Fax
Email
ghasemi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)