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The effect of eight weeks of regular walking on pregnancy outcomes in Nulliparous women

Protocol summary

Summary
The goal of this study to determine the effect of an eight week program of regular walking on pregnancy out comes in a group of nalliparous women. 80 heithy ,non athlete ,null iparoes housewife(20-35 years of age)whit a single cephalic presentstion in a clinical trial study on their 28th week of gestation. They were randomally allocated into two equal (experiment and control) groups participants were excluded at anytime during the study by personal request or by physician order. Exercise protocol consisted of 3-5minutes of warm up do the training for 30min then 3-5 min cool down, three times a week for8week at a self-selected walking speed. Outcome study: length,head circumference ,weight first and five minutes APGAR , meconium passage, spo2 maternal outcomes :gestational age , type of delivery ,Mother overweight, phase birth mother to a hospital admission , the duration of the active phase , duration of the pregnancy termination lengh of stay in hospital until discharge ,FBS,HB,HCT. Keyword : pregnancy outcome , maternal outcome, Neonatl outcome, nulliparous

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014100119351N1
Registration date: 2014-11-20, 1393/08/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-20, 1393/08/29
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
Islamic Azad Univercitr of Damghan
Expected recruitment start date
2014-03-06, 1392/12/15
Expected recruitment end date
2014-07-06, 1393/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of regular walking on pregnancy outcomes in Nulliparous women
Public title
The impact of walking in pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Single pregnancY؛ Healthy ؛ Non-athletes ؛Is a housewife؛ Is a resident of Damghan؛ Plans do cover labor in velayat hospital of damghan؛ Have between 20 and 35 years of age؛Position as head of the fetus in the womb. ؛ Prenatal care under obstetricians do؛ In the intervention group practice physicians licensed to perform the protocol؛ You are now ready for childbirth classes. Exclusion: Mother to keep the plan to withdraw for any reason؛ Practice expectant mother's physician orders cut to give any reaso؛ Researcher due to lack of regular exercise to eliminate maternal samples. :
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Damghan
Street address
cheshmeh ali street, Islamic Azad University of Damghan
City
Damghan
Postal code
3671637881
Approval date
2014-03-01, 1392/12/10
Ethics committee reference number
21049

2

Ethics committee
Name of ethics committee
Velayat Hospital Health Network of Damghan
Street address
Saadi Square,cheshmeh ali street .Velayat Hospital
City
Damghan
Postal code
3671637881
Approval date
2014-03-01, 1392/12/10
Ethics committee reference number
92/21/1785/و

Health conditions studied

1

Description of health condition studied
Exercise in pregnancy
ICD-10 code
z34.8
ICD-10 code description
supervision of other normal pregnancy

Primary outcomes

1

Description
Hct
Timepoint
After& befor the intervention.
Method of measurement
cell cunter

2

Description
FBS
Timepoint
After& befor the intervention.
Method of measurement
outoanalaizer

3

Description
Getational age
Timepoint
After intervation
Method of measurement
Last menstural period -mother rcord

4

Description
Duration of the pregnancy termination
Timepoint
After the intervention.
Method of measurement
Mother records

5

Description
Passage of meconium
Timepoint
After the intervention.
Method of measurement
Mother records

6

Description
Mother over weghit
Timepoint
After& befor the intervention.
Method of measurement
Adult Weighing Scales

7

Description
Neonatal Length
Timepoint
After intervation
Method of measurement
Height gauges baby

8

Description
Neonatal weghit
Timepoint
after intervation
Method of measurement
Neonatal Weighing Scales

9

Description
First minute apgar
Timepoint
After intervation
Method of measurement
Measured by Apgar

10

Description
Five minutes apgar
Timepoint
After the intervention.
Method of measurement
Table Apgar assessment criteria

11

Description
Type of delivery
Timepoint
After the intervention.
Method of measurement
Mother records

12

Description
The duration of the active phase
Timepoint
After the intervention.
Method of measurement
partograf

13

Description
Phase birth mother to a hospital admission
Timepoint
After the intervention.
Method of measurement
Mother records

14

Description
Arterial oxygen saturation percentage
Timepoint
After the intervention.
Method of measurement
Pulse oxy meter

15

Description
Length of stay in hospital until discharge
Timepoint
After the intervention.
Method of measurement
Mother records

16

Description
HB
Timepoint
After& befor the intervention.
Method of measurement
cell cunter

17

Description
Added at 2015-02-27:body mass index
Timepoint
Added at 2015-02-27: Pre - pregnancy and term pregnancy
Method of measurement
Added at 2015-02-27: adault pregnant nemogram (BMI)for pregnancy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention in interventation group Exercise protocol consistted of three of five minute of warmup ؛30 minute of training followed Based on the principle of overload.first week walking 10 min secend week 20 min Third Week 30 min then three to five minutes of cool down repeated 3 days a week for 8 consecutive week at a self-selected walking speed. intensity so that thay can easily walk and talk .
Category
Other

2

Description
Control Groups: no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat hospital of Damghan
Full name of responsible person
Tayebe Zarezade
Street address
No. 50, Ayatollah Ghaffari Street
City
Damghan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University of Damghan
Full name of responsible person
Dr Nematallah Nemati
Street address
Islamic Azad University of Damghan
City
Damghan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Damghan
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
Islamic Azad University of Damghan
Full name of responsible person
Tayebe Zarezade
Position
Bachelor of Midwifery-Graduate Student in Exercise Physiology
Other areas of specialty/work
Street address
Islamic Azad University of damghan
City
Damghan
Postal code
397136647
Phone
+98 23 3523 1711
Fax
tana_zarezade@yahoo.com tayebezarezade21@yahoo
Email
tana_zarezade@yahoo.com tayebezarezade21@yahoo.tana_zarezade@yahoo.com tayebezarezade21@yahoo.com ta
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Damghan
Full name of responsible person
Tayebe Zarezade
Position
Midwife expert&Graduate student in exercise physiology
Other areas of specialty/work
Street address
No. 50, Ayatollah Ghaffari Street
City
Damghan
Postal code
3671736647
Phone
+98 23 3523 1711
Fax
-
Email
tayebezarezade@semums.ac.irr
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Damghan
Full name of responsible person
Tayebe zarezade
Position
Midwife expert&Graduate student in exercise physiology
Other areas of specialty/work
Street address
No.50, Ayatollah Ghaffari Street
City
Damghan
Postal code
3671736647
Phone
+682 335231711
Fax
-
Email
tayebezarezade@semums.ac.irtana_zarezade@yahii.comtayebezarezade21@gmail.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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