Protocol summary

Study aim
The effect of betamethasone injection on maternal and neonatal outcomes in pregnant women with a gestational age of 34 to 37 weeks
Design
All mothers will be randomly divided into two groups: group A (intervention group or treatment with betamethasone) and group B (control group or normal saline injection). A randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
All pregnant women with preterm labor symptoms with gestational age of 34 to the end of 36 weeks at Shahid Sayad Shirazi Hospital in Gorgan, double blind clinical trial All medical staff involved in the study will be unaware of the grouping and medication or the placebo receiving by subjects due to coding process and the similarity of the drug and placebo packages.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age between 34-37 weeks, preterm labor symptoms in gestational ages between 34-37 weeks , corticosteroids injection indication before childbirth according to the specialist diagnosis, consent to participate in the study exclusion criteria: intrauterine growth retardation, congenital malformation, Multiple pregnancies, placental abruption, systemic maternal diseases (diabetes, cardiovascular disease and endocrine), receiving two doses of betamethasone before the study, dissatisfaction to participate in the study
Intervention groups
Intramuscular injection of betamethasone 12 mg at 2 doses for 24 hours will be given to the intervention group and the same volume of normal saline with the same intervals to the control group.
Main outcome variables
Respiratory distress syndrome, neonatal death, need for hospitalization in the neonatal intensive care unit, increased FBS and 2Hpp 6 weeks after delivery for mother

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191202045571N1
Registration date: 2020-07-17, 1399/04/27
Registration timing: registered_while_recruiting

Last update: 2020-07-17, 1399/04/27
Update count: 0
Registration date
2020-07-17, 1399/04/27
Registrant information
Name
Fakhere Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3220 2565
Email address
drtaheri.f@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of betamethasone injection on maternal and neonatal outcomes in pregnant women with gestational age 34-37 weeks exposed to preterm labor in Sayyad Shirazi Hospital, Gorgan.
Public title
The effect of betamethasone injection in pregnant women exposed to preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 34-37 weeks, Preterm labor symptoms between the ages of 34-37 weeks gestation Need for prenatal corticosteroid injection according to specialist's diagnosis Consent to participate in the study
Exclusion criteria:
Cases of intrauterine growth retardation (IUGR) Congenital malformations Multiple pregnancies Placenta previa Maternal systemic diseases (diabetes, Cardiovascular and endocrine disease ) Receiving two doses of betamethasone before study
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
We use the block randomization method to randomize subjects into groups that result in equal sample sizes. We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into two groups according to the order and fill the blocks A for intervention and B for placebo B A B A 2) B B A A 1) B A A B 4) A B B A 3) A A B B 6) A B A B 5)
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomization process will be performed without anyinterference of the people who involved in the study. The drug and the placebo will be prepared in similar packages without the possibility of identification. Based on the classification, The people entered in the study will receive their own coded packages based on the specified classification, and the results will be recorded separately based on the coding on the packages and specifications of the studing groups. At the end of the study, the analyzer will use the sample codes and coding instructions to access the nature of the groups for analysis and conclusion.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2019-10-20, 1398/07/28
Ethics committee reference number
IR.GOUMS.REC.1398.223

Health conditions studied

1

Description of health condition studied
Preterm labor
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Incidence of diabetes and hyperglycemia in mothers
Timepoint
FBS and 2Hpp check 6 weeks after delivery for mothers and for infants up to one week later.
Method of measurement
Laboratory measurements of FBS and 2Hpp

2

Description
incidence of respiratory distress syndrome in neonates
Timepoint
Neonatal Respiratory Distress Syndrome
Method of measurement
based on neonates clinical manifestation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A (Betamethasone Intervention)Intervention Betamethasone 12 mg(Iran Hormone production) intramuscular injection , 2 doses ,Daily
Category
Treatment - Drugs

2

Description
Control group: group B ( control group or placebo), 1 cc Normal Salin (Iran Hormone production) , intramascular injection, 2 doses , daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sayyad Shirazi Hospital
Full name of responsible person
Dr. Shohreh Vosough
Street address
Philosophical Higher Education Complex, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
shohre.007@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Philosophical Higher Education, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fakhere Taheri
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
fakhere21@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fakhere Taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
fakhere21@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fakhere Taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
fakhere21@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of data to complement research on the adverse effects of corticosteroids in pregnant women
From where data/document is obtainable
Contact the author of the article responsible for the research project data.
What processes are involved for a request to access data/document
Contact the author of the article responsible for the research project data.Specify the type of results requested.
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