This clinical trial has been designed to determine the effect of exercise programme with birth ball during pregnancy on duration of labor stages in nulliparous women. Study subjects are Iranian women 35-18 years old with term pregnancy, without history of infertility, singleton pregnancy who have Body mass index in normal range, and without any chronic illnesses or antenatal complications (low-risk pregnancies) in current pregnancy. After explaining aims of study and getting consent and confidence of gestational age, subjects will be randomly assigned to one of two groups: exercise program with the birth ball and usual care. After training by 20 minutes video film about exercise programme with the birth ball to intervention group, a birth ball, booklet and training CD will be given to mothers, and we will ask mothers to perform the exercise with help of trained attendant, three times a week at Home and once a week in the hospital setting for 20 minutes until onset of labor. usual care will be done for mothers in control group. Both groups will be asked to go to the hospital at the onset of labor and inform the researcher. The researcher will be present in Hospital and in absence of exclusion criteria during study, they will be controlled by researcher, at the end of active phase of labor and second stage of labor are compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012816392N1
Registration date:2014-06-15, 1393/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-15, 1393/03/25
Registrant information
Name
Zahra Hejazinia
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 4455 3314
Email address
hejaziniaz901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad Universityof Medical Sciences
Expected recruitment start date
2013-09-16, 1392/06/25
Expected recruitment end date
2014-03-17, 1392/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Exercise program with the birth ball on duration of labor stages in nulliparous women
Public title
The effect of Exercise program with the birth ball during pregnancy on duration of labor stages
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Iranian women who are living in Mashhad city; nulliparus or primiparous women; age 18 to 35 years old; pregnant women between 37-38 weeks; singleton pregnancy; BMI in the normal range; low-risk pregnancies; no Regular exercise during pregnancy.
Exclusion criteria: not willingness to participate in research; not doing exercise program three times or more; emergency caesarean section; use of traditional, herbal medicines or other methods to facilitate delivery; smoking, alcohol consumption and substance abuse; induction of labor before 37 complete weeks.
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:
60
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
Mashhad Universityof Medical Sciences
Street address
Building Qureshi, Daneshgah Avenue, mashhad
City
Mashhad
Postal code
Approval date
2013-05-26, 1392/03/05
Ethics committee reference number
920056
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z37.0
ICD-10 code description
Single live birth
Primary outcomes
1
Description
Duration of the active phase of labor
Timepoint
End of study
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Duration of second stage of labor
Timepoint
End of study
Method of measurement
Questionnaire
Intervention groups
1
Description
After practical training and face to face and videotape(20 minutes) to intervention group and attendant person, was given to pregnant women a birth ball with booklet, 20-minute training video on CD with check list to ensure implementation of exercise program at home and was asked from mothers is performed this movement until onset of labor(from 34 weeks to term) with the help of attendant trained, three times a week at Home and once a week in the Hospital setting for 20 minutes.the subjects taught about symptoms of the onset of labor,and was requested them go to Hospital at onset of labor with informed to researcher .
Category
Other
2
Description
In control group,pregnant women were controlled weekly(from 34 weeks to term)
until onset of labor.the subjects taught about symptoms of the onset of labor, and was requested them go to Hospital at onset of labor with informed to researcher .