Protocol summary
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Study aim
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Evaluation of the effectiveness of 17 alpha-hydroxyprogestrone on decreasing abortion and preterm labor
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Design
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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
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Preterm labor and the second trimester abortion
General information
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Reason for update
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Updating the trial according to the last changes in inclusion and exclusion criteria, actual number of cases, date of recruitment and trial completion
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Acronym
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IRCT registration information
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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
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Registration date
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2012-12-24, 1391/10/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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ُShahid Sadoughi University of Medical Siences
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Expected recruitment start date
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2010-10-23, 1389/08/01
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Expected recruitment end date
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2011-03-30, 1390/01/10
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Actual recruitment start date
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2010-10-23, 1389/08/01
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Actual recruitment end date
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2011-08-30, 1390/06/08
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Trial completion date
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2011-10-28, 1390/08/06
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Scientific title
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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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Public title
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The effect of progestrone on preterm labour in patient who are pregnant with ART teqnique
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
106
Actual sample size reached:
99
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2010-10-27, 1389/08/05
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Ethics committee reference number
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پ/17/1/81633
Health conditions studied
1
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Description of health condition studied
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preterm labour
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ICD-10 code
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O60,O75
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ICD-10 code description
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complication of labour and delivery
Primary outcomes
1
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Description
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Labour under37week/34-37week-32-34week and second trimestre abortion
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Timepoint
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weekly from16-36weeks of gestation
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Method of measurement
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Quastisonaries
2
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Description
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Etiology of preterm labour
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Timepoint
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Weekly from16-36weeks of gestations
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Method of measurement
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Quastionaries
Secondary outcomes
1
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Description
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NICU admission
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Timepoint
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After live birth
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Method of measurement
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Quastionaries
2
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Description
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Neonatal birth weigh
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Timepoint
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After live birth
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Method of measurement
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Quastionaries
3
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Description
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Drug complication
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Timepoint
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Weekly from16-36 weeks of gestation
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Method of measurement
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Quastionaries
Intervention groups
1
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Description
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control group:drug with all chachtristic of of 17alpha- hydroxyprogestrone caproate:only without efficient material of this drug:intramusculary injected from16-36weeks of gestation
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Category
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Placebo
2
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Description
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Drug group:17alpha-hydroxyprogestrone caproate(FEMOLIFE)intramusculary injected from16-36weeks of gestation
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Aburaihan Pharmacy company
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participant data sets are to be shared
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When the data will become available and for how long
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2 months after the result publication
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To whom data/document is available
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A journal in which the results are published
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Under which criteria data/document could be used
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Submission of an official application via the agent that is legally in charge
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
983538247085
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What processes are involved for a request to access data/document
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Submission of an official application via the agent that is legally in charge
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Comments
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