Protocol summary

Summary
The aim of this study is to investigate the effects of husband attendance at prenatal care on pregnancy outcomes in Sabzevar in 1387-88. This is an interventional, single blind and randomized study, carried out on 186 pregnant women receiving prenatal care in health services in Sabzevar. Inclusion criteria were first pregnancy, wanted pregnancy, first marriage, monogamy, gestational age less than 14 weeks, being healthy and exclusion criteria included abortion and husband attendance in less than 4 sessions. In each centers women randomly were allocated in two groups. In control group women received routine care and in intervention group, they attended with their husband in prenatal sessions and received same care. Collecting data was done using interview guide included information about demographic and obstetrics history and pregnancy outcomes, weight gain during pregnancy and infant birth weight. In first postpartum visit, information about birth weight,delivery type and gestational age at the time of delivery were collected.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112288548N1
Registration date: 2012-01-29, 1390/11/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-29, 1390/11/09
Registrant information
Name
Foroughossadat Mortazavi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
frmortazavi@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of husband participation at prenatal care on pregnancy outcomes
Public title
Effect of husband participation at prenatal care
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria : first pregnancy ; gestational age less than 14 weeks ; husband attendance in prenatal care exclusion criteria: abortion ; husband attendance in less than 4 prenatal care
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 186
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
Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, road police station, Sabzevar
City
Sabzevar
Postal code
Approval date
2008-07-13, 1387/04/23
Ethics committee reference number
122/2156

Health conditions studied

1

Description of health condition studied
Pregnancy outcomes
ICD-10 code
Z34.0
ICD-10 code description
Supervision of normal first pregnancy

Primary outcomes

1

Description
weight gain during pregnancy
Timepoint
14, 20, 28,36 weeks of pregnancy
Method of measurement
scales

2

Description
birth weight
Timepoint
after birth
Method of measurement
scales

Secondary outcomes

1

Description
mother satisfaction of husband involvement in prenatal care
Timepoint
2 weeks postpartum
Method of measurement
questionaire

Intervention groups

1

Description
control: Routine care
Category
N/A

2

Description
intervention: Education (Education of pregnancy health to pregnant woman and her husband in 20 minutes in each session)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemmat abad Health Center
Full name of responsible person
Molok Rashidi
Street address
City
Sabzevar

2

Recruitment center
Name of recruitment center
Aldaghi Health Center
Full name of responsible person
Street address
City
Sabzevar

3

Recruitment center
Name of recruitment center
Health Center Number 3
Full name of responsible person
Street address
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr, Akbar Pejhan
Street address
Sabzevar University of Medical Sciences, Police Station, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Foroughossadat Mortazavi
Position
Lecturer, Faculty Member
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, police station, Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6030
Fax
Email
frmortazavi@medsab.ac.ir
Web page address
www.medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Foroughossadat Mortazavi
Position
Master of Sciences
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Police Station, Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1222 4831
Fax
Email
frmortazavi@medsab.ac.ir
Web page address
www.medsab.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Foroughossadat Mortazavi
Position
Faculty Member/Master of Sciences
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Police Station, Sabzevar
City
Sabzevar
Postal code
Phone
00
Fax
Email
frmortazai@medsab.ac.ir
Web page address
www.medsab.ac.ir

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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