Investigation of the effect of a cycle of exercises on pregnancy outcomes
Objectives:the present study aims to determine the relationship between exercising and pregnancy outcomes
Design: this stady is a clinical trial and The randomization was done in the draw that The method of sampling was simple sample into two groups.
Setting and conduct: in this stady 120 pregnant women were randomly divided into an intervention and a control group
Major Inclusion criteria:primiparous ;18-35 years old; gestational age of 20 weeks ; singleton pregnancy ; being primiparous; not having the history of pregnancy complications; not having the history of doing professional sports; and normal Body Mass Index (BMI=20-25 )
Exclusion criteria: were suffering from underlying diseases; women’s or pregnancy disorders; having known pregnancy complications; having limitations for doing physical activities; and not being willing to participate in the study.
Intervention: The intervention group participants were required to do aerobic exercises for 8 weeks since the 20th week of gestation in addition to receiving the routine care. However, the control group mothers only received the routine pregnancy care
main outcome measures (variables): Then pregnancy outcomes; such as length of pregnancy; delivery phases; type of delivery; and infants’ physiological indexes; such as Apgar score ; weight; height; and head circumference were measuring.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403167497N3
Registration date:2016-02-18, 1394/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Monireh Tousi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3832 0151
Email address
toosim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of a cycle of exercises on pregnancy outcomes in Primigravida Women
Public title
the effect of cycle of exercises on pregnancy outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
primiparous ;18-35 years old; gestational age of 20 weeks ; singleton pregnancy ; being primiparous; not having the history of pregnancy complications; not having the history of doing professional sports; and normal Body Mass Index (BMI=20-25 )
Exclusion criteria:
were suffering from underlying diseases; such as hypertension ; thyroid disorders; women’s or pregnancy disorders; diabetes; epilepsy;cardiovascular diseases; renal disorders; and pulmonary diseases; having known pregnancy complications; such as polyhydramnios; oligohydramnios; placenta previa;detachment; known fetal disorders; intrauterine death; cervical insufficiency;history of infertility; bleeding during pregnancy; and pain; having limitations for doing physical activities; and not being willing to participate in the study.
.
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street, Shiraz University of Medical Sciences, Shiraz
City
Shiraz
Postal code
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.SUMS.REC.1394.151
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
2
Description of health condition studied
delivery
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section
3
Description of health condition studied
delivery
ICD-10 code
O81
ICD-10 code description
Single delivery by forceps and vacuum extractor
4
Description of health condition studied
delivery
ICD-10 code
O83
ICD-10 code description
Other assisted single delivery
Primary outcomes
1
Description
duration of pregnancy
Timepoint
After delivery
Method of measurement
Chart
2
Description
type of delivery
Timepoint
after intervention
Method of measurement
chart
3
Description
apgar scor
Timepoint
after intervention
Method of measurement
Chart
4
Description
back pain
Timepoint
after intervention
Method of measurement
visual scale of pain
Secondary outcomes
1
Description
Assess back pain
Timepoint
The begain of intervention and after intervention
Method of measurement
the 10 point Visual Analog Scale (VAS)
Intervention groups
1
Description
The intervention group subjects were required to do aerobic exercises 30 minutes a day, three days a week for 8 weeks. Aerobic exercise program started with 5 minutes warming, continued with the main plan which usually lasted for 20 minutes, and ended with cooling for 5 minutes. These exercises were strictly supervised by the instructor and the midwife. In each session, 10 types of aerobic exercises were performed, including warming for 5 minutes, stretching exercises, and cooling for 5 minutes. The intensity of exercises was controlled by measuring the participants’ heartbeat; such a way that their heartbeat would not exceed 140 beats per minute (bpm)
the control group mothers only received the routine pregnancy care
Category
Behavior
2
Description
The control group participants, on the other hand, only received the routine care without performing aerobic exercises.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Zinabieh hospital ,zinabieh street , shiraz
Full name of responsible person
Monireh Toosi
Street address
Shiraz University of Medical Sciences, shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr.seyed basier hashemi
Street address
Zand street, Shiraz University of Medical Sciences , shiraz
City
Shiraz
Grant name
9401859123
Grant code / Reference number
Ir.sums.rec.1394.151
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
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
Zand street, Shiraz University of Medical Sciences ,shiraz
Full name of responsible person
Monireh toosi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Zand street,School of Nursing and Midwifery,shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
Toosim_m@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zand street , Shiraz University of Medical Sciences ,shiraz
Full name of responsible person
Monireh toosi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Zand street , School of Nursing and Midwifery, shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
Toosim_m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz
Full name of responsible person
Monireh Toosi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Zand street,School of Nursing and Midwifery, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
Toosim_m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)