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Evaluating the Effectiveness of Pregnant Women Empowerment Program on Elements of Empowerment and Their Satisfaction of Prenatal Cares.

Protocol summary

Summary
Objective: to investigate the effectiveness of pregnant women empowerment program on elements of empowerment and their satisfaction of prenatal cares. Design : a clinical trail with an intervention group (group antenatal care) and a control group (traditional antenatal care). The sample size: the total number of samples by using of OpenEpi software, and related article was chosen 70 person. In each group will be 35 person. The sampling is easy And allocation of sampels in each intervention and control groups will be randomly. Participation: potential participants for either group have to be healthy pregnant women, without medical or obstetric complications of pregnancy, between the ages 18 and 35, and Iranian person. Those who do not fit these criteria are excluded. Method: the empowerment program abolishes routine prenatal care by bringing women out of examination rooms and into groups for their care_ risk assessment, education , and support_ into one entity. Women are placed into groups of 8 to 9 based on estimated dates of delivery and meet for five 120-minute prenatal visits at regular intervals that begin when women are 13 weeks pregnant, and end when women are 36 weeks pregnant. In each session women measure their own blood pressure, weight themselves and record these results in their charts. Then, women are taken individually to a corner of the group room for fundal and fetal heart tone checks. During this time, each woman has the opportunity to build community with other pregnant women, learn self-care skills, get assurance about the progression of her pregnancy, and gain knowledge about pregnancy, birth, and parenting.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904142248N5
Registration date: 2011-12-31, 1390/10/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-31, 1390/10/10
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of Medical Sience
Expected recruitment start date
2011-12-26, 1390/10/05
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of Pregnant Women Empowerment Program on Elements of Empowerment and Their Satisfaction of Prenatal Cares.
Public title
Effectiveness of Pregnant Women Empowerment Program on Their Empowerment and Satisfaction.
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria for entry into the study: 1- Iranian- pregnant women 2- Women with gestational age age 13 weeks. 3- Without known physical and mental illnesses. 4- Ages 18 to 35 years. 5- Able for reading and writing. 6- Singleton pregnancy. 7- If she has a history of childbirth, natural childbirth. Exclusion criteria from the study: 1- During the study, mothers who are involved in adverse events such as death of loved ones. 2- During the study, mothers who are involved by complication of pregnancy such as: Abortion, hypertension, toxemia of pregnancy, gestational diabetes, intrauterine fetal death, premature labor. 3- Mothers who don’t desire to continue. 4- Mothers who didn’t attend at least in two sessions of training sessions.
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: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical sience
Street address
keshavarz boulevard
City
Tehran
Postal code
Approval date
2011-12-24, 1390/10/03
Ethics committee reference number
1796

Health conditions studied

1

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

Primary outcomes

1

Description
pregnant women empowerment
Timepoint
36 gestational age
Method of measurement
pregnant women empowerment questionair

Secondary outcomes

1

Description
saticfaction of care
Timepoint
36 gestational age
Method of measurement
Adams and litelfild saticfaction questionaire

Intervention groups

1

Description
in the intervention group, prenatal care and education will be held in five group session. each session is 120 minutes which has two parts. care part is 30 minutes that will be done by pregnant women who already have learned how to measure weight and vital signs. education part is 90 minutes that will be done into group discusion.
Category
Other

2

Description
There is not any intervention in control group. care and education to be done individually.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Prenatal clinic, Akbarabadi Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university of medical sience, vice chancellor for research
Full name of responsible person
Dr. Akbar Fotuhi
Street address
khods street, keshavarz boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical sience, vice chancellor for research
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
Tehran university of medical sience, school of midwifery and nursing
Full name of responsible person
Mahin Balouchi Mahani
Position
Master of midwifery
Other areas of specialty/work
Street address
Vali asr Alley ,south sheikh Ahmad kaffi street
City
kerman
Postal code
Phone
+98 34 1321 9886
Fax
Email
mahinbalouchi@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sience, school of midwifery and nursing
Full name of responsible person
Fereshte Jahdi
Position
Master of midwifery
Other areas of specialty/work
Street address
Tohid squar, school of midwifery and nursing
City
Tehran
Postal code
Phone
+98 21 2242 6076
Fax
Email
jahdi_fr@yahoo.com
Web page address

Person responsible for updating data

Contact

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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