Objective: Presenting a pattern of postpartum care at home and its effects on the health of the mother and suckling. Method: This interventional study is a randomized trial. First, we reach a unique pattern by summarizing data from the study of the pattern of postpartum care at home in different countries. Then by gathering journalists’ and stakeholders’ comments there will be changes in accordance with the needs of the country. The study population is woman who have given birth in Shohada, Imam Hossein, Taleqani and Mahdieh hospitals. After obtaining consent, 270 eligible mothers are elected successively, we allocate 90 people in intervention group and 180 people in control group. Inclusion criteria: Iranian nationality; no gestational hypertension and Diabetes; single embryo with normal birth weight; having a score less than 14 in Edinburg questionnaire. Exclusion criteria: unwillingness to continue the study for any reason; immigration from the areas of study. The type of intervention for both groups is providing service in accordance with the approved pattern at home and to visit in days of 3-5 and 13-15 after the delivery.The control group won’t be provided with home service.The review of the results will be conducted on days 42-60 and mother and suckling health indices between two groups will be compared. These indices include using supplementation by mother and suckling, postpartum depression, mother hospitalization due to the complications after childbirth, exclusive feeding with breast milk, infant hospitalization after the first 28 days of childbirth and common physical complications in mothers in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060313565N1
Registration date:2013-12-07, 1392/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-07, 1392/09/16
Registrant information
Name
Parastoo Amiri
Name of organization / entity
Shaheed Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 2563
Email address
amiri.parasto@gmail.com
Recruitment status
Recruitment complete
Funding source
Shaheed Beheshti University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-01-05, 1392/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Presenting a Pattern of Postpartum Care at Home and Its
Effects on the Health of the Mother and the Suckling
Public title
Effects of Postpartum Care at Home on the Health of the Mother and Suckling
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Iranian nationality; no gestational hypertension, preeclampsia and gestational diabetes; single embryo with normal birth weight;no congenital anomalies; having a score less than 14 in Edinburg questionnaire. Exclusion criteria: unwillingness to continue the study for any reason; immigration from the areas of study
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
270
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
Shaheed Beheshti University of Medical Sciences
Street address
Velenjak , Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2012-11-11, 1391/08/21
Ethics committee reference number
0308/11470
Health conditions studied
1
Description of health condition studied
Postpartum Period
ICD-10 code
Z39.1, Z39
ICD-10 code description
Care and examination of lactating mother, Routine postpartum follow-up
Primary outcomes
1
Description
Using supplementation in mother in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
2
Description
Using supplementation in suckling in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
3
Description
Using the contraceptive methods in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
4
Description
Incidence of Postpartum depression in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
Edinburg questionarie
5
Description
Mother hospitalization due to complications after childbirth in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
6
Description
Exclusive feeding with breast milk in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
7
Description
Breast problems in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
8
Description
Constipation in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
9
Description
Hemorrhoids in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
10
Description
Backache and lumbago in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
11
Description
Fatigue in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionarie
Secondary outcomes
1
Description
Satisfaction rate in intervention and control groups
Timepoint
42-60 days after intervention
Method of measurement
questionares
Intervention groups
1
Description
The type of intervention for both groups is providing service in accordance with the approved pattern at home and to visit in days of 3-5 and 13-15 after the delivery. Visits are done by trained midwives or nurses. The average time of visit is considered between 30-45 minutes, which is flexible according to mothers’ demands.The service provider’s phone number is given to mothers in case of any problems. Caregivers will be trained before the intervention, so there will be integration in the caring method.
Category
Prevention
2
Description
The control group won’t be provided with home service.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdie Hospital
Full name of responsible person
Dr. Mehrdad Izadi , Hospital administration
Street address
Shoosh ".Sq." ,Fadaeian Eslam".Av."
City
Tehran
2
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
ِDr.seid Mohammad Taghi Hosseini Tabatabae, Hospital administration
Street address
Tehran, Shaheed Madani Avenue
City
Tehran
3
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Abbas Haj Fathali , Hospital administration
Street address
Velenjak, shahid chamran highway
City
Tehran
4
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Dr.Badiozaman Radpey, Hospital administration
Street address
Tajrish, Qods ".Sq."
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Dr.Hossein Goodarzi
Street address
Velenjak, Shahid Chamran Highway
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, Shaheed Beheshti 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
Shaheed Beheshti university of Medical Sciences
Full name of responsible person
Parastoo Amiri
Position
Resident of Community medicine
Other areas of specialty/work
Street address
Velenjak,Shaheed Beheshti Faculty of medicine,Eighth floor,Public health & Community medicine department
City
Tehran
Postal code
Phone
+98 21 2243 9936
Fax
Email
Amiri.Parasto@gmail.com ; Amiri_Parasto@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Beheshti university of Medical Sciences
Full name of responsible person
Dr.Hourieh Shamshiri Milani
Position
assistant professor
Other areas of specialty/work
Street address
Velenjak,Shaheed Beheshti Faculty of medicine,Eighth floor,Public health & Community medicine department
City
Tehran
Postal code
Phone
+98 21 2243 9936
Fax
Email
Hourieh_Milani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Parastoo Amiri
Position
Resident Of Community Medicine
Other areas of specialty/work
Street address
Velenjak,Shaheed Beheshti Faculty of medicine,Eighth floor,Public health & Community medicine department
City
Tehran
Postal code
Phone
+98 21 2243 9936
Fax
Email
Amiri.Parasto@gmail.com ; Amiri_Parasto@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)