We propose a randomized, double blind; placebo controlled clinical trial of prednisolone for woman with idiopathic recurrent miscarriage and raised levels of Natural Killer cells in the peripheral blood. All patients who fit the inclusion criteria: age 20-40 years old; history of more than 2 consecutive miscarriage with no cause found; CD 56 more than 12 or CD 16/56 more than 8 and no contraindication to prednisolone therapy, will be allow to enter the study. One hundred women with high level of peripheral Natural Killer cells will be randomized to either prednisolone or placebo groups. Follow up by checking CD56 and CD16/56 included 2 months before and after prednisolone or placebo therapy and at 8, 12 and 20 weeks of gestational age. The primary aim is to investigate whether prednisolone therapy before and during the pregnancy is able to improve live birth rates in patients with idiopathic recurrent miscarriage and decrease Natural Killer cells in peripheral blood. Secondary out comes include conception rate, still births, pregnancy complications, gestational age of delivery and side effects of prednisolone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110915342N1
Registration date:2014-05-12, 1393/02/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-12, 1393/02/22
Registrant information
Name
Rashin Zargham
Name of organization / entity
Jahad Research Institute of Avicenna
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
r.zargham@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Infertility and Recurrent Abortion Center
Expected recruitment start date
2013-11-21, 1392/08/30
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial of prednisolone for women with idiopathic recurrent miscarriage and raised levels of Peripheral natural killer cells .
Public title
The effect of Prednisolone in reducing of recurrent abortion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female gender; being a case of idiopathic abortion; in flow cytometry of peripheral blood, CD56 more than 12 or CD 16/56 more than 8.
Exclusion criteria: age less than 20 or more than 40 years old; having less than 2 abortions; history of abortion more than 20w of gestational age; uterine disorder; chromosomal disorder in couples; antiphospholipid syndrome; contraindication of corticosteroid; abnormal thyroid function test result.
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:
100
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
Avicenna Research Institute Ethical Committee
Street address
Avicenna Research Institute, Evin
City
Tehran
Postal code
117719615
Approval date
2013-10-22, 1392/07/30
Ethics committee reference number
92020
Health conditions studied
1
Description of health condition studied
Idiopathic Recurrent Abortion
ICD-10 code
O03
ICD-10 code description
Miscarriage
Primary outcomes
1
Description
Abortion
Timepoint
12th and 20th weeks of gestation
Method of measurement
Patients file
2
Description
Live birth
Timepoint
After Birth
Method of measurement
Patient file
Secondary outcomes
1
Description
Peripheral Natural Killer Cell
Timepoint
Before intervention, 2 months after intervention, 8th, 12th, 20th weeks of gestation
Method of measurement
Flow cytometry
2
Description
Chemical pregnancy
Timepoint
1 week after retardation of mens
Method of measurement
Positive beta-hcg test
3
Description
Pre eclampsia
Timepoint
After 20th week of gestation
Method of measurement
Blood pressure measuring
4
Description
Drug Complications
Timepoint
After Treatment
Method of measurement
Patients files
5
Description
Gestational Diabetes
Timepoint
After 20th week of gestation
Method of measurement
FBS, GCT, GTT
6
Description
IUGR
Timepoint
After 28th week of gestation
Method of measurement
Obstetrical ultrasound scan
7
Description
Clinical Pregnancy
Timepoint
After 5-6 th week of gestation
Method of measurement
Obstetrical Ultra Sound Scan
8
Description
Ongoing Pregnancy
Timepoint
After 7th week
Method of measurement
Obstetrical Ultrasound Scan
9
Description
Gestational age at delivery
Timepoint
After 24th week of gestation
Method of measurement
Patient file
10
Description
Feotal Abnormality
Timepoint
At 20th weeks gestation
Method of measurement
Anomaly Ultrasound Scan
Intervention groups
1
Description
Case group are treated with prednisolone with this protocol: prednisolone 2 months before taking action to pregnancy; first week 20 mg daily; second week 15 mg daily ; third to seventh week 10 mg daily ; eighth week 5 mg daily.Then recheck NK-cell density , if there is suitable response, taking action to pregnancy will be allowed .After positive pregnancy test ,restarting prednisolone or placebo with this protocol:10mg daily until 14th week of gestational age ,when the dose will be tapered off and stopped. In addition, both of groups equally are treated with empirical treatment which have been effective in past studies of idiopathic recurrent abortion, including : ASA-FA5mg-vit B6.
Category
Treatment - Drugs
2
Description
Control group with placebo before and during pregnancy ;with this protocol: placebo 2 months before taking action to pregnancy; first week 20 mg daily; second week 15 mg daily ; third to seventh week 10 mg daily ; eighth week 5 mg daily.Then recheck NK-cell density , if there is suitable response, taking action to pregnancy will be allowed .After positive pregnancy test ,restarting placebo with this protocol:10mg daily until 14th week of gestational age ,when the dose will be tapered off and stopped. In addition, both of groups equally are treated with empirical treatment which have been effective in past studies of idiopathic recurrent abortion, including : ASA-FA5mg-vit B6.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Infertility and Recurrent Abortion Center
Full name of responsible person
Dr. Rashin Zargham
Street address
No. 97, Yakhchal Avenue, Shariati Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Dr. Mohammad Mehdi Akhoondi
Street address
No 97, Yakhchal Avenue, Shariati Street, Tehran, Iran
City
Tehran
Grant name
113641
Grant code / Reference number
92-020
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Research Institute
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
Avicenna Infertility and Recurrent Aborsion Center
Full name of responsible person
Dr Rashin Zargham
Position
Gynecologist
Other areas of specialty/work
Street address
No. 97, Yakhchal Avenue, Shariati Street, Tehran
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
+98 21 2264 4754
Email
r.zargham@avicenna.ac.ir; zargham_dr@yahoo.com
Web page address
www.avicenna.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Avicenna Infertility and Recurrent Aborsion Center
Full name of responsible person
Dr. Fatemeh Razzaghi, Dr.Saeed Zarei, Dr. Rashin zargham
Position
Gynecologist
Other areas of specialty/work
Street address
No. 97, Yakhchal Avenue, Shariati Street, Tehran
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
+98 21 2264 4754
Email
r.zargham@avicenna.ac.ir; zargham_dr@yahoo.com
Web page address
www.avicenna.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Avicenna Infertility Center
Full name of responsible person
Dr Rashin Zargham
Position
Gynecologist
Other areas of specialty/work
Street address
No. 97, Yakhchal Avenue, Shariati Street, Tehran
City
Tehran
Postal code
1941913114
Phone
+98 21 23519
Fax
+98 21 2264 4754
Email
r.zargham@avicenna.ac.ir; zargham_dr@yahoo.com
Web page address
www.avicenna.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)