Thje aim of this study is to assess the effect of hydroxychloroquine on unexplained recurrent abortion.This clinical trial would be conducted as a prospective and double blind survey. Inclusion criteria is women with at least 2 unexplained recurrent abortion and exclusion criteria is women with lupus and underlying diseases. Our sample size is 60. After getting informed consent of participants,they will be randomly divided into tow groups of intervention and control.After positive pregnancy test, the intervention group will receive 200 mg hydroxychloroquine 2 times a day up to the twentieth gestational week, and control group will receive placebo as the same way of intervention group. Patients would be monitored by sonography in 6-8, 11-13 and 18-22 of gestational weeks and outcomes of pregnancy and its complicationes will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120910664N2
Registration date:2016-07-18, 1395/04/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-18, 1395/04/28
Registrant information
Name
Reihaneh Pirjani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3288
Email address
pirjani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Experimental Medicine Research Center of Tehran University of Medical Science
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of hydroxychloroquine on the treatment of unexplained recurrent abortion in women referred to Arash hospital
Public title
Effect of hydroxychloroquine on recurrent abortion treatment
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : women with more than 2 unexplained abortion
exclusion criteria: women with rheumatoid; lupus erythematosus; underlying and heart diseases; smoking; consumption of alcohol and supplement; radiation contact
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, Qods Streetو Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.TUMS.REC.1395.2743
Health conditions studied
1
Description of health condition studied
recurrent abortion
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion
Primary outcomes
1
Description
spontaneous abortion
Timepoint
any time during study
Method of measurement
observational
Secondary outcomes
1
Description
Intrauterine death
Timepoint
after 20 weeks of gestation
Method of measurement
observational
2
Description
preeclampsia
Timepoint
all the duration of pregnancy
Method of measurement
clinical and laboratory examination
3
Description
low birth weight
Timepoint
after birth
Method of measurement
weighing
4
Description
preterm labor
Timepoint
before 37 th week of gestation
Method of measurement
observational
5
Description
congenital morphological abnormalities
Timepoint
after birth
Method of measurement
observational
Intervention groups
1
Description
intervention group: After confirming the positive pregnancy test, patients will receive tablet of 200 mg hydroxychloroquine twice a day up to the twentieth week of pregnancy.Sonography will be done in weeks of 6-8, 11-13 and 18-22 of pregnancy.
Category
Treatment - Drugs
2
Description
control group: After confirming the positive pregnancy test, patients will receive placebo twice a day up to the twentieth week of pregnancy.Sonography will be done in weeks of 6-8, 11-13 and 18-22 of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women hospital
Full name of responsible person
Dr.Reihaneh Pirjani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Experimental Medicine Research Centerof Tehran University of Medical Science,Vice chancellor for res
Full name of responsible person
Dr Masoud Younesian
Street address
Tehran University of Medical Science, Keshavarz boulevard, Qods street,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Experimental Medicine Research Centerof Tehran University of Medical Science,Vice chancellor for res
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
Arash Women 's Hospital, Tehran University of Medical sciences
Full name of responsible person
Dr. Reihaneh Pirjani
Position
Associated professor
Other areas of specialty/work
Street address
Arash women hospital, Rashid streert,Tehranpars
City
Tehran
Postal code
Phone
+98 21 7788 3196
Fax
Email
pirjani@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science, Arash women hospital
Full name of responsible person
Dr.Reihaneh Pirjani
Position
associated professor
Other areas of specialty/work
Street address
Arash women hospital, Rashid street, Resalat highway,Tehranpars
City
Tehran
Postal code
Phone
+98 21 7788 3196
Fax
Email
pirjani@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical sciences
Full name of responsible person
Dr. Reihaneh Pirjani
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)