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Evaluation the Effect of 17 alpha-hydroxyprogestrone caproate on dcreasing preterm labour and second trimester miscarriage in women pregnant with ART

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History
# Registration date Revision Id
3 2021-12-27, 1400/10/06 218287
2 2021-04-13, 1400/01/24 178885
1 2012-12-24, 1391/10/04 11443
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  • Recruitment centers

    #1
    Name of recruitment center - English: Madar hospital
    Name of recruitment center - Persian: بیمارستان مادر
    Full name of responsible person - English: Hoora Amuzegar
    Full name of responsible person - Persian: حورااموزگار
    Street address - English: Yazd,Mhdieh square,Imam Sadegh Boulevard
    Street address - Persian: یزد/میدان مهدیه/بلوارامام جعفرصادق
    City - English: yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916714169
    Phone: +98 35 3623 0030
    Fax: +98 35 3624 5277
    Email: Info@madarhospital.com
    Web page address: http://madarhospital.com

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Shahid Sadoughi University of Medical Siences of Yazd
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Dr. Masood Mirzaie
    Full name of responsible person - Persian: دکتر مسعود میرزایی
    Street address - English: Central Committee of Medical University, Bahonar sq, Yazd
    Street address - Persian: یزد، میدان باهنر، سازمان مرکزی دانشگاه علوم پزشکی شهید صدوقی یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3724 0171
    Fax:
    Email: dvc.research@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Aburaihan Pharmacy company
    Name of organization / entity - Persian: شرکت دارویی ابوریحان
    Full name of responsible person - English: Aburaihan Pharmacy company
    Full name of responsible person - Persian: شرکت دارویی ابوریحان
    Street address - English: Tehran,Corner of Tehranpars three way,In front of City hotel.No.1
    Street address - Persian: تهران /نبش سه راه تهرانپارس/مقابل هتل شهر/پلاک1
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1654613111
    Phone: +98 21 7770 7173
    Fax: +98 21 7770 2066
    Email: info@aburaihan.com
    Web page address: http://aburaihan.com
    -
    empty
    100
    50
    Public
    Private
    Academic
    Industry
    -
    empty
    empty
    Shahid Sadoughi University of Medical Siences of Yazd
    Aburaihan Pharmacy company
    دانشگاه علوم پزشکی شهید صدوقی یزد
    شرکت دارویی ابوریحان

Protocol summary

Study aim
Evaluation of the effectiveness of 17 alpha-hydroxyprogestrone on decreasing abortion and preterm labor
Design
Women who met inclusion criteria, were informed about the trial design and signed a written consent form. Participants were consecutively enrolled the study and randomly divided into two groups using randomized list. Participants enrolled in a randomized parallel, double-blind, phase 2 clinical trial with control group. Randomization was performed using random number table
Settings and conduct
Women who got pregnant after ART at Yazd Infertility Center and were at 16th week of gestational age were randomly divided into two groups of 7-α hydroxy progesterone and placebo. A double blind trial was performed using placebo (similarity in amount, shape and administration method). patients and data analyzer were blinded to the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who got pregnant after ART and were at 16 weeks of gestational age. Exclusion criteria: Twin or multiple pregnancies; history of preterm labor; history of previous abortion; history of chronic diseases (Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism); uterine anatomical problems
Intervention groups
Intervention group: intramuscularly injection of 250 mg17-α hydroxy progesterone from16 to 36 weeks of gestation Control group: intramuscularly injection of 250 mg placebo from16 to 36 weeks of gestation
Main outcome variables
Preterm labor and the second trimester abortion

General information

Reason for update
Updating the trial according to the last changes in inclusion and exclusion criteria, actual number of cases, date of recruitment and trial completion
Acronym
IRCT registration information
IRCT registration number: IRCT2012101611132N1
Registration date: 2012-12-24, 1391/10/04
Registration timing: retrospective

Last update: 2022-02-26, 1400/12/07
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
2011-03-30, 1390/01/10
Actual recruitment start date
2010-10-23, 1389/08/01
Actual recruitment end date
2011-08-30, 1390/06/08
Trial completion date
2011-10-28, 1390/08/06
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:
Pregnancy using ART Gestational age of 16 weeks Using progesterone for luteal phase support
Exclusion criteria:
Twin or multiple pregnancies History of preterm labor History of previous abortion History of chronic diseases such as Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism Uterine anatomical problems
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 106
Actual sample size reached: 99
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, 99 women who conceived through ART at 16th weeks of pregnancy were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and statistical analyzer both were blind about the drug or placebo. In placebo group injections were done by a drug similar in shape and volume, but without progesterone which was prepared by the same company as placebo. All injections have done by trained nurses who were blinded about the type of drugs.
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
Province
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
After live birth
Method of measurement
Quastionaries

2

Description
Neonatal birth weigh
Timepoint
After live birth
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
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatoonian@yahoo.com

2

Recruitment center
Name of recruitment center
Madar hospital
Full name of responsible person
Hoora Amuzegar
Street address
Yazd,Mhdieh square,Imam Sadegh Boulevard
City
yazd
Province
Yazd
Postal code
8916714169
Phone
+98 35 3623 0030
Fax
+98 35 3624 5277
Email
Info@madarhospital.com
Web page address
http://madarhospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Aburaihan Pharmacy company
Full name of responsible person
Aburaihan Pharmacy company
Street address
Tehran,Corner of Tehranpars three way,In front of City hotel.No.1
City
Tehran
Province
Tehran
Postal code
1654613111
Phone
+98 21 7770 7173
Fax
+98 21 7770 2066
Email
info@aburaihan.com
Web page address
http://aburaihan.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aburaihan Pharmacy company
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

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
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Reseach and Clinical Centre for Infertility, Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35182470856
Fax
+98 35 3824 7087
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
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Centre, Bouali Ave, Safaeyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 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
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Centre, Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
amuzegarhoora@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participant data sets are to be shared
When the data will become available and for how long
2 months after the result publication
To whom data/document is available
A journal in which the results are published
Under which criteria data/document could be used
Submission of an official application via the agent that is legally in charge
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085
What processes are involved for a request to access data/document
Submission of an official application via the agent that is legally in charge
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