Protocol summary

Summary
Objectives: Mothers with history of unsuccessful breast feeding considered as mothers with high risk of breast feeding and other interventions in pregnancy and beyond routine prenatal care programs should be conducted. Design: The aim of this program is to improve breastfeeding and avoid repeating previous breastfeeding experience is desirable. This study examines the impact of women with a positive history of breast support on breastfeeding patterns of mothers with a history of breastfeeding was unsuccessful. Setting and conduct: In this randomized clinical trial, 150 pregnant women with a history of unsuccessful breastfeeding randomly assigned to experimental and control groups. The control group program included the routine trainings. Case group program included the routine trainings plus the support from 1mother with positive breast feeding experience during the first 3months after delivery. Participants including major criteria: Inclusion in the study group: the desire to be together, living in Gorgan; be available; at least be literate; with a singleton pregnancy is unsuccessful in her last lactation; must be 37 weeks gestational age; the mother has to be a low-risk pregnancy (no illness, surgery, and midwifery is not known); fetal abnormality is not known. Inclusion of Sponsor: Must be a resident of Gorgan; be literate, have a successful breastfeeding experience; is not a debilitating disease; might be willing to cooperate in the project. Inclusion excluded mothers who are available for telephone consultation; any problems for the mother during labor or after delivery that the baby needs to stay in the hospital. Interventions: In this study, women with a history of successful advocacy support breastfeeding mothers by telephone and in person if received 37 weeks of pregnancy. She supports at least once a week until the end of the third month continued. The main outcome measures: in the first, second and third month the rate of exclusive breast feeding in case and control groups were compared.

General information

Acronym
no
IRCT registration information
IRCT registration number: IRCT2013010111964N1
Registration date: 2013-05-15, 1392/02/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-15, 1392/02/25
Registrant information
Name
Roya Sadat Etemadi
Name of organization / entity
International branch of Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 17 1552 7275
Email address
roya6163@yahoo.com
Recruitment status
Recruitment complete
Funding source
Iinvestigator
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-04-18, 1391/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of peer support on the pattern of breastfeeding among mothers with a history of unsuccessful breastfeeding in Gorgan health centers 1390
Public title
The effect of peer support on the pattern of breastfeeding among mothers with a history of unsuccessful breastfeeding .
Purpose
Supportive
Inclusion/Exclusion criteria
Participants including major criteria: Inclusion in the study group: the desire to be together, living in Gorgan; be available; at least be literate; with a singleton pregnancy is unsuccessful in her last lactation; must be 37 weeks gestational age; the mother has to be a low-risk pregnancy (no illness, surgery, and midwifery is not known); fetal abnormality is not known. Inclusion of Sponsor: : Must be a resident of Gorgan; be literate, have a successful breastfeeding experience; is not a debilitating disease; might be willing to cooperate in the project. Inclusion excluded mothers who are available for telephone consultation; any problems for the mother during labor or after delivery that the baby needs to stay in the hospital.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 168
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

1

Registry name
Not registered
Secondary trial Id
Not registered
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of international branch of Shahid Beheshti University
Street address
No 19, near Hemmat highway, Tavanir Avenue, Tehran
City
Tehran
Postal code
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
2864/116

Health conditions studied

1

Description of health condition studied
Disease is not studied in this trial.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breastfeeding pattern
Timepoint
One, two and three month after sampling
Method of measurement
Breastfeeding assessment questionnaire

Secondary outcomes

1

Description
Dominant breast feeding
Timepoint
One, two and three month after sampling
Method of measurement
Breastfeeding assessment questionnaire

Intervention groups

1

Description
. The control group program included the routine trainings. Case group program included the routine trainings plus the support from 1mother with positive breast feeding experience during the first 3months after delivery. Breast feeding patterns were evaluated by the end of the first, second and third months.
Category
Other

2

Description
Phone number, address and name of each sponsor several of the mothers who were matched for age, socioeconomic status, education and living there will be similarities and the rest of the calls will be made as needed. Telephone Support Group provides research, monitoring and support will be put up in case of problems breastfeeding, should be referred to medical centers.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Gorgan Health Centers
Full name of responsible person
Manager of Center
Street address
Emam Town
City
Gorgan

2

Recruitment center
Name of recruitment center
Gorgan Health Centers
Full name of responsible person
Manager of Center
Street address
Modares Square
City
Gorgan

3

Recruitment center
Name of recruitment center
Gorgan Health Center
Full name of responsible person
Manager of Center
Street address
Enghelab Avenue
City
Gorgan

4

Recruitment center
Name of recruitment center
Gorgan Health Center
Full name of responsible person
Manager of Center
Street address
Vali Asr Avenue
City
Gorgan

5

Recruitment center
Name of recruitment center
Gorgan Health Center
Full name of responsible person
Manager of Center
Street address
Naharkhoran Avenue
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Science
Full name of responsible person
Doctor Ghanati
Street address
No 19, near Hemmat highway, Abbasour Avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Science
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
International branch of Shahid Beheshti University
Full name of responsible person
Roya Sadat Etemadi
Position
Student
Other areas of specialty/work
Street address
No 19, near Hemmat highway, Tavanir Avenue, Tehran
City
Tehran
Postal code
Phone
+98 17 1552 7275
Fax
Email
roya6163@yahoo.com; esperso_6226@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Torkzahrani Shahnaz
Position
Master Science
Other areas of specialty/work
Street address
School of Nursing Midwifery Shahid Beheshti, Tehran
City
Tehran
Postal code
Phone
+98 21 8856 0717
Fax
Email
zahranishahnaz@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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