An Investigation of Sport Intervention in Pregnant Mothers in Pregnant Gestational Disease Prevention
Design
This is a randomized, parallel clinical trial study.
Settings and conduct
The study will be conducted in Damghan, Iran. Mothers at risk and with gestational diabetes will be detected based on clinical practice guidelines for screening, diagnosis, and treatment before and during pregnancy and after childbirth by Ministry of Health and Medical Education (2019); and having gestational diabetes will be finally approved by a gynecologist.
Pregnant mothers introduced by specialist physicians from genealogy offices and clinics, and by midwifery staff at urban health centers will be evaluated by the main researcher in terms of inclusion criteria, nutritional status and physical activity level ( by completing the international Pregnancy Physical Activity Questionnaire (PPAQ) and a Food Frequency Questionnaire (FFQ)).
Participants/Inclusion and exclusion criteria
Entrance: pregnant women who have normal fasting plasma glucose in their first pregnancy tests.
Exit: one of the obstacles to not doing exercise in pregnancy.
Intervention groups
The intervention group will have an exercise intervention program for 8 sessions, 3 sessions per week, each lasting for 45 minutes, and the comparison group will have routine physical activity while receiving routine prenatal care.
Main outcome variables
Fasting plasma glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141001019351N2
Registration date:2019-07-02, 1398/04/11
Registration timing:prospective
Last update:2019-07-02, 1398/04/11
Update count:0
Registration date
2019-07-02, 1398/04/11
Registrant information
Name
Tayebe Zarezade
Name of organization / entity
Azad univercity of Damghan
Country
Iran (Islamic Republic of)
Phone
+98 23 2523 1711
Email address
tayebezarezade@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supervised exercise in the prevention of gestational diabetes mellitus in nulliparous women: A randomized control clinical trial
Public title
Effect of exercise on preventing gestational diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
.Healthy pregnancy
Normal Fasting plasma glucose in the first weeks of pregnancy
Gestational age 18 to 20 weeks to start the plan
Mother age 18 to 35 years old
A resident of Damghan
Control and care of pregnancy in the city of Damghan
Contraindications without exercisein Pregnancy
Adherence to the implementation of the plan
Exclusion criteria:
One of the obstacles to not doing exercise in pregnancy
Mother's request to leave the plan at any time
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done after initial registration and obtaining informed consent. Random allocation will be done based on a list obtained from www.Randomization.com. After entering the required information, this website provides two lists of 40 people in two groups of intervention and comparison. At the end of each week, the project secretary will place subjects in the order of entry into the study in the intervention and comparison lists
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a parallel randomized clinical trial.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
islamic azad university, semnan branch
Street address
islamic azad university, damghan branch
City
damghan
Province
Semnan
Postal code
36716 39998
Approval date
2018-12-06, 1397/09/15
Ethics committee reference number
IR.IAU.SEMNAN.REC.1398.002
Health conditions studied
1
Description of health condition studied
Gestational diabetes melitus (GDM)
ICD-10 code
O00-O08
ICD-10 code description
Pregnancy with abortive outcome
Primary outcomes
1
Description
FPG fasting plasma glucose
Timepoint
Week 7 to 10 and 24 to 28 weeks pregnant
Method of measurement
Fasting Blood Sampling
Secondary outcomes
1
Description
OGTT(50Glocose)
Timepoint
24- 28 gestational age
Method of measurement
Blood test
2
Description
Pregnant mother weighing
Timepoint
The first trimester of gestation, the second trimester of pregnancy, the third trimester of pregnancy, the termination of pregnancy
Method of measurement
Weighing scale for adults
3
Description
Type of delivery
Timepoint
At birth
Method of measurement
The case is admitted to the pregnant mother's hospital
4
Description
Baby weight
Timepoint
The first hour of birth
Method of measurement
Baby weighing scale
5
Description
Baby's height
Timepoint
The first hour of birth
Method of measurement
Measuring meter
6
Description
Round the head of the baby
Timepoint
The first hour of birth
Method of measurement
Measuring meter
7
Description
Baby's chest
Timepoint
The first hour of birth
Method of measurement
Measuring meter
8
Description
Apgar's first minute baby
Timepoint
The first minute of the baby's birth
Method of measurement
Apgar score for baby
9
Description
Apgar's fifth minute baby
Timepoint
The fifth minute of the baby's birth
Method of measurement
Apgar score for baby
10
Description
Duration of hospitalization
Timepoint
From hospital admission to discharge
Method of measurement
The case is admitted to the pregnant mother's hospital
11
Description
Gestational age at the end of pregnancy
Timepoint
At birth
Method of measurement
Gestational age based on ultrasound 8 to 10 weeks based on CRL
12
Description
Percent oxygen saturation
Timepoint
Minutes 1- 2 -3 -4 -5 -10
Method of measurement
Baby Oximeter pulse device
13
Description
Duration of active phase of labor
Timepoint
When admitted to the hospital for termination of pregnancy
Method of measurement
Hospital file - Partograph form
14
Description
Determining the rate of admission to the hospital after delivery
Timepoint
The first 24 hours of birth
Method of measurement
Newborn hospital records
15
Description
The need for resuscitation measures in the baby
Timepoint
Baby birth
Method of measurement
Newborn hospital records
16
Description
Childbirth injuries
Timepoint
The first 24 hours after birth
Method of measurement
Newborn hospital records
17
Description
Maternal Maternal Injuries
Timepoint
The first 2 hours after childbirth
Method of measurement
Maternity hospital file
Intervention groups
1
Description
Intervention group: The intervention group program will be based on the principles of the design of the workout, by specifying the duration, severity, repetition, and type of exercise. The duration of the training in the first week is 60 minutes, in the second week, 100, and the third week, 150, and from the fourth week thereafter, 160 minutes. will be . Exercise intensity throughout the week with moderate intensity and based on the severity of talk test. Repeat the exercise in the first week, 4 times a week, the first two days, 10 minutes and 2 days later, 20 minutes, and from the second week, 5 days a week. Which will be divided according to the timing between days. Types of exercise in the first week, three times a week, once a practice of aerobics and Pilates, and from the second week to two days of walking and three days of aerobic and Pilates exercises during pregnancy. Aerobic exercises include a warming and cooling program and cardio exercises, and Pilates exercises are called seated xeecise exercises.
Category
Prevention
2
Description
Control group: Control group can take physical activity while receiving usual care during pregnancy.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Private health clinics and specialized clinics and velayat hospital in Damghan
Full name of responsible person
tayebeh zarezadeh
Street address
Damghan velayat Hospital
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5124
Fax
+98 23 3522 5129
Email
velayathos@semums.ac.ir
Web page address
https://velayathos.semums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nematallah Nemati
Street address
Islamic Azad University of Damghan Branch
City
Damghan
Province
Semnan
Postal code
3671637849
Phone
+98 23 3522 5024
Fax
+98 23 3522 5024
Email
nnemati258@gmail.com
Web page address
http://www.damghaniau.ac.ir/
Grant name
does not have
Grant code / Reference number
ندارد
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
tayebeh zarezadeh
Position
phd student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Damghan velayat Hospital
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5124
Fax
+98 23 3522 5129
Email
velayathos@semums.ac.ir
Web page address
https://velayathos.semums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
tayebeh zarezadeh
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Damghan velayat Hospital
City
damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5124
Fax
+98 23 3522 5129
Email
velayathos@semums.ac.ir
Web page address
https://velayathos.semums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
tayebeh zarezadeh
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Damghan velayat Hospital
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5124
Fax
+98 23 3522 5129
Email
velayathos@semums.ac.ir
Web page address
https://velayathos.semums.ac.ir/
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2019Ethic form: 2019
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD:counseling and delivery service of the Avayetavalod
What processes are involved for a request to access data/document
IPD:Application form for the researcher and, if agreed, coordinated with the secretary of the design and attendance at the counseling and delivery service of the Avayetavalod