This study aims to determine the effect of midwife’s supportive care during labour on onset of lactogenesisII and exclusive breastfeeding. In a randomized clinical trial study, 80 primigravida women in Omolbanin Hospital in Mashhad will be recruited. The inclusion criteria for subjects are:gestational age 38-42 weeks, single foetus and live with cephalic presentation, cervical dilation 3-4 cm, no medical and obstetric complications and no evidence of fetal distress. Subjects will be allocated randomly into supportive care and usual care groups. Women with medical complications and congenital malformations in infant will be excluded. Experimental group will receive supportive care including physical, educational and emotional support during active phase of labour and also the first hours after delivery by the researcher. Control group will receive usual labour and delivery care by staff midwives. Labour progress and breastfeeding status will be monitored and recorded by the researcher in both groups. In both groups appearance of clinical symptoms of lactogenesisII (mother reports milk leaking) will be determined through daily phone contacts during postpartum period. In addition mothers will be asked to fill a daily checklist about infants feeding from birth until the sixth weeks following delivery. The onset of lactogenesis II and frequency of exclusive breastfeeding at the end of four and six weeks will be compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810122956N1
Registration date:2010-05-25, 1389/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-25, 1389/03/04
Registrant information
Name
Masoumeh Kordi
Name of organization / entity
Nursing and Midwifery Schoo, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
kordim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2008-09-11, 1387/06/21
Expected recruitment end date
2009-04-08, 1388/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of midwife’s supportive care during labor on onset of lactogenesisII and exclusive breastfeeding
Public title
Midwife’s supportive care and breastfeeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: primigravida women, gestational age 38-42 weeks, single foetus, live with cephalic presentation, cervical dilation 3-4 cm, no medical and obstetric complications and no evidence of foetal distress. Exclusion criteria: Medical complications and congenital malformations in infant
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah ave, Mashhad, Iran
City
Mashhad
Postal code
91375345
Approval date
empty
Ethics committee reference number
86367
Health conditions studied
1
Description of health condition studied
Neonatal difficulty in feeding at breast
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
Onset of lactogenesisII
Timepoint
One weekes after birth
Method of measurement
Questionnaire, checklist
Secondary outcomes
1
Description
Exclusive breastfeeding
Timepoint
Six weekes after birth
Method of measurement
Cheklist of daily newborn feeding record
Intervention groups
1
Description
Experimental group will receive supportive care including physical, educational and emotional support during active phase of labor and also the first hours after delivery by the researcher
Category
Prevention
2
Description
Control group will receive usual labor and delivery care by staff midwives
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Omolbanin Hospital in Mashhad
Full name of responsible person
Massomeh kordi
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne sina St., Chaharah Doktora Crossing
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
http://www.mums.ac.ir/research
Street address
Ghoreishi building, Daneshgah Ave., Mashhad-Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Massomeh Kordi
Position
M.Sc. of Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne sina St., Chaharah Doktora Crossing
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
+98 51 1859 7313
Email
kordim@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Massomeh Kordi
Position
M.Sc. of Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne sina St., Chaharah Doktora Crossing
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
0O985118597313
Email
kordim@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Mdwifery
Full name of responsible person
Massomeh Kordi
Position
M.Sc. of Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne sina St., Chaharah Doktora Crossing
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
+98 51 1859 7313
Email
kordim@mums.ac.ir
Web page address
www.mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)