A comparative study on the effect of presence trained attendant and midwifery student in labor on some maternal and neonatal outcomes in nulliparous women
Comparison of mean pain score in the second stage of labor in intervention and control groups
Comparison of mean anxiety score in intervention and control groups
Comparison of Childbirth Satisfaction in intervention and control groups
Design
This is Randomizes Clinical Trial (RCT) study with a minimization method based on age and education and has two intervention and one control group and they are parallel. The sample size consists of 90 people and no medicine is used.
Settings and conduct
In this RCT study; The statistical population consists of pregnant women who referring to pregnancy classes. The sample size was estimated based on the statistical formula and calculated 30 people in each group (90 people total). The sampling method is randomization and the allocation will be done with the minimization method.
The first intervention group is the last year midwifery students and the second intervention is a member of the pregnant mother's family and this study also has a control group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Willingness to to NVD
Delivery at Niknafs Maternity Center of Rafsanjan
Singleton pregnancy
Age: 18 to 35 years
Exclusion Criteria:
The presence of medical disease
Absolute contraindications of workout
Intervention groups
The first intervention group is a last-year midwifery student and the second intervention group is a member of the pregnant mother's family.
Two intervention groups participate in pregnancy classes as mother's companions and will be in the pain room during childbirth to reduce delivery pain.
The control group includes only mothers (as participants) and will be alone in pregnancy classes and pain room without any companion.
Main outcome variables
The mean pain and anxiety score in the first stage of labor and the mean childbirth satisfaction score after delivery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044248N2
Registration date:2020-06-29, 1399/04/09
Registration timing:registered_while_recruiting
Last update:2020-06-29, 1399/04/09
Update count:0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Zahra Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
z.saghafi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-08-15, 1399/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of presence trained attendant and midwifery student in labor on some maternal and neonatal outcomes in nulliparous women
Public title
A comparative study on the effect of presence trained attendant and midwifery student in labor on some maternal and neonatal outcomes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Willingness to to Normal Vaginal Delivery (NVD)
Delivery at Niknafs Maternity Center of Rafsanjan
Mother age: 18-35 years
Gestational age: 20 weeks or more than it based on reliable first-trimester ultrasound or last menstrual period
Singleton pregnancy
Exclusion criteria:
The presence of medical disease
Absolute contraindications of workout
History of psychological problems during 6 month ago
Consumption of Antidepressant medication
Drug consumption
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
We will use convenience sampling. Among people referring to pregnancy classes, everybody who has inclusion criteria allocate with a minimization method based on age and education of variables. For each group, the first sample enters the study by the lottery method (Flip a coin). For the next samples, we consider the total number of the samples in every three groups and assign the sample to a group that has a lower number of members, and if the total number of samples in these groups becomes equal again, we will use the lottery method.
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
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Emam Ali Blvd, Organization Center of Rafsanjan University of Medical Sciences, Rafsanjan, Iran.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.RUMS.REC.1397.157
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Pain
ICD-10 code
F45.4
ICD-10 code description
Pain disorders related to psychological factors
Primary outcomes
1
Description
The mean time of first labor stage
Timepoint
From the active phase of labor to the second stage of it.
Method of measurement
Childbirth checklist
Secondary outcomes
1
Description
Mean of pain score
Timepoint
The active phase of labor (from 4 cm dilation to full dilation of cervix)
Method of measurement
Checklist
Intervention groups
1
Description
The first intervention group is a last-year midwifery student that participates in pregnancy classes as mother's companions and will be in the pain room during childbirth to reduce delivery pain.
Category
Prevention
2
Description
The second intervention group is a member of the pregnant mother's family that participates in pregnancy classes as mother's companions and will be in the pain room during childbirth to reduce delivery pain.
Category
Prevention
3
Description
The control group includes only mothers (as participants) and will be alone in pregnancy classes and pain room without any companion.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Niknafs Maternity Center of Rafsanjan
Full name of responsible person
Asmat Javadi
Street address
No. 4, 7th Alley, South Panzdah-e-Khordad Ave
City
Rafsanjan
Province
Kerman
Postal code
7716765965
Phone
+98 34 3425 9030
Email
449@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Shamsizadeh
Street address
Emam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
7718146890
Phone
+98 34 3428 0072
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?