object: evaluation the effect of 17 alpha-hydroxyprogestrone caproate on decreasing miscarriage and preterm labour in women who are pregnant with ART Material and Method: We condoucted double blind placebo clinical trial on 106 pregnant women .
Inclusion criteria: succesful singletone pregnant women with ART teqnique at 16 weeks of gestation without history of previous preterm labour and without chronic disease and without cecellage and privious structural uterine anomalies(exclusion criteria)
Intervention: drug and placebo was injected intramuscularly from16-36weeks of gestation
Primary outcome: preterm labour and second trimestre abortion
Secondary outcome: neonatal outcome and drug complication
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101611132N1
Registration date:2012-12-24, 1391/10/04
Registration timing:retrospective
Last update:
Update count:2
Registration date
2012-12-24, 1391/10/04
Registrant information
Name
Hoora Amuzegar
Name of organization / entity
Yazd University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 25 1772 2560
Email address
abbas_aflatonian@yahoo.com
Recruitment status
Recruitment complete
Funding source
ُShahid Sadoughi University of Medical Siences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2012-03-05, 1390/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of 17 alpha-hydroxyprogestrone caproate on dcreasing preterm labour and second trimester miscarriage in women pregnant with ART
Public title
The effect of progestrone on preterm labour in patient who are pregnant with ART teqnique
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women who have succesful pregnancies; who are at16 weeks of gestation; who are singletone pregnancy
Exclusion criteria: they have not chronic disease; privious preterm labour; they have not structural uterine anomaly; they have not under cercellage
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
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
Shahid Sadooghi medical university of Yazd
Street address
Central Committee of Medical University, Bahonar sq, Yazd
City
Yazd
Postal code
7240171-5
Approval date
2010-10-27, 1389/08/05
Ethics committee reference number
پ/17/1/81633
Health conditions studied
1
Description of health condition studied
preterm labour
ICD-10 code
O60,O75
ICD-10 code description
complication of labour and delivery
Primary outcomes
1
Description
Labour under37week/34-37week-32-34week and second trimestre abortion
Timepoint
weekly from16-36weeks of gestation
Method of measurement
Quastisonaries
2
Description
etiology of preterm labour
Timepoint
weekly from16-36weeks of gestations
Method of measurement
Quastionaries
Secondary outcomes
1
Description
NICU admission
Timepoint
Only the end of gestation
Method of measurement
Quastionaries
2
Description
birth weigh
Timepoint
Only the end of gestation
Method of measurement
Quastionaries
3
Description
drug complication
Timepoint
weekly from16-36 weeks of gestation
Method of measurement
Quastionaries
Intervention groups
1
Description
control group:drug with all chachtristic of of 17alpha- hydroxyprogestrone caproate:only without efficient material of this drug:intramusculary injected from16-36weeks of gestation
Category
Placebo
2
Description
Drug group:17alpha-hydroxyprogestrone caproate(FEMOLIFE)intramusculary injected from16-36weeks of gestation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Centre for Infertility of Yazd
Full name of responsible person
Dr. Abbas Aflatonian
Street address
Research and Clinical Centre for Infertility, Bouali Ave, Safaeyeh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Siences of Yazd
Full name of responsible person
Dr. Masood Mirzaiy
Street address
Central Committee of Medical University, Bahonar sq, Yazd
City
Yazd
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Siences of Yazd
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
Reseach and Clinical Centre for Infertility of Yazd
Full name of responsible person
Dr. Hoora Amuzegar
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Reseach and Clinical Centre for Infertility, Bouali Ave, Safaeyeh
City
Yazd
Postal code
89195-999
Phone
+98 35182470856
Fax
+98 82 47087
Email
amuzegarhoora@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Centre for Infertility of Yazd
Full name of responsible person
Dr. Abbas Aflatonian
Position
Obstetrics and Gynecologyst and Proffesor of Infertility
Other areas of specialty/work
Street address
Infertility Centre, Bouali Ave, Safaeyeh, Yazd
City
Yazd
Postal code
89195-999
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
abbas_aflatonian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Centre for Infertility of Yazd
Full name of responsible person
ِDr. Hoora Amuzegar
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Infertility Centre, Bouali Ave, Safaeyeh
City
Yazd
Postal code
89195-999
Phone
+98 35 1824 7085
Fax
+98 82 47087
Email
amuzegarhoora@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)