Protocol summary

Summary
The aim of this study was to determine the impact of postpartum care in home on health behavior, quality of life and satisfaction in low-risk mothers. This randomized intervention study was done on 200 mothers in two groups (intervention=100 and control=100). The participants were selected among mothers that refer to Akbar Abad health center for neonatal screening tests. Control group received postpartum cares in health centers and intervention group received these cares in home (in every group 2 visits on 15±2 and 45±2 days after delivery). Health behaviors (nutritional behavior, infant cares, breastfeeding, personal and sexual health, family planning, physical activity, exposing to the sun, smoking, alcohol and drugs consuming), quality of life and satisfaction of mothers were compared in two groups 2 weeks after last visit (45±2 days).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201009204785N1
Registration date: 2011-04-10, 1390/01/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-10, 1390/01/21
Registrant information
Name
Seyedeh Tahereh Mirmolaei
Name of organization / entity
Nursing and Midwifery Faculty - Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982166927171- 00982166937120
Email address
mirmolaei@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical siences
Expected recruitment start date
2010-07-06, 1389/04/15
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of postpartum care at home on the health behavior and quality of life of low risk mothers
Public title
Postpartum care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: First and second baby Healthy and term baby Persian language mothers Mothers resident in regions 10, 11 , 17 of Tehran Mothers and infant without any physical and mental diseases Low risk recent pregnancy Exclusion criteria: Movement without information to researcher Migration from study regions or Tehran city Divorce Hospitalization more than 72 hours (mothers and infant) Notreceived two times of mother care
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
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
Tehran university of medical siences
Street address
Ghods street, Keshavarz street
City
Tehran
Postal code
Approval date
2010-07-03, 1389/04/12
Ethics committee reference number
89.130.410

Health conditions studied

1

Description of health condition studied
Postpartum care
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination

Primary outcomes

1

Description
health behavior
Timepoint
before intervention, 2 weeks after intervention
Method of measurement
questionnaire

2

Description
quality of life
Timepoint
before intervention, 2 weeks after intervention
Method of measurement
questionnaire

3

Description
satisfaction
Timepoint
2 weeks after intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention included two home visits (on 15±2 and 45±2 days after delivery) for giving postpartum care according to recent recommendations of Health Ministry protocol. These cares include assessing vital signs, infant growth and complications in mother and infant, observation and examination, and health education.
Category
Other

2

Description
Control group receivded routine post partumcare (on 15±2 and 45±2 days after delivery) in health center.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of Akbarabad
Full name of responsible person
Dr. Yalda
Street address
Akbar Abad Health Center, next to the education, Sina street, Navab highway
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Deputy of research
Street address
6th floor, University Central Building, Ghods street, Keshavarz street, Tehran
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 Sciences and Health Services
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 Sciences and Health Services
Full name of responsible person
Zeinab Tavakol
Position
M.Sc. Midwifery student
Other areas of specialty/work
Street address
301th room, 4th Golestan, Tehran University of Medical Siences dormitory, Kargar street
City
Tehran
Postal code
Phone
+98 913 188 2963
Fax
Email
tavakolz@razi.tums.ac.ir zeinab.tavakol@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Seyedeh Tahereh Mirmolaei
Position
M.Sc. of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Nosrat street, Tohid square
City
Tehran
Postal code
Phone
+98 912 224 5100
Fax
Email
mirmolaei@sina.tums.ac.irst_mirmolaei@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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