Comparison of the efficacy of breast milk and erythromycin gel and breast protector during breast fissure remission
Design
The randomized controlled clinical trial was performed with parallel groups, with no blinding
Settings and conduct
Breastfeeding mothers were required to explain the purpose of the study after being satisfied with the inclusion criteria and a written consent was obtained.Sampling is done in a lactation clinic of Mobini Hospital in Sabzevar, Iran, as a randomized interventional study.
Participants/Inclusion and exclusion criteria
Breastfeeding mothers who score at least three on the Estor scale and have a fever within the first six weeks after delivery,Infant with abnormalities in mouth and palate, maxillofacial and maternal skin diseases, autoimmune diseases and diabetes.
Intervention groups
The first group should apply erythromycin gel on the nipple and the aura three times daily as a finger band,The second group is to put the breast protector on the nipple before breastfeeding and hold it during sucking.
Main outcome variables
Breast severity; severity of pain caused by breast fissure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041970N1
Registration date:2019-12-01, 1398/09/10
Registration timing:prospective
Last update:2019-12-01, 1398/09/10
Update count:0
Registration date
2019-12-01, 1398/09/10
Registrant information
Name
Fateme Shojaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3509 9349
Email address
fateme.sh7752@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of erythromycin gel and protective breast and breast milk on breastfeeding lactating women
Public title
Comparison of the efficacy of erythromycin gel and protective breast and breast milk on breastfeeding lactating women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Catch the fissure and get at least a score of three from the Storey scale
Occurrence of fissure within the first 6 weeks after delivery
Ages 18-35 years
Exclusive Breastfeeding
Normal-weight single-term labor(2500-4000)
Willingness to participate in the study
Exclusion criteria:
Infant with abnormalities in the mouth, palate, jaw and face
The mother has nipple malformations or previous nipple surgeries
Maternal skin disease and autoimmune diseases and diabetes
Nipple sores
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:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done as a randomized interventional study.
In order to uniformize the degree of breast fissure, a stratified random method will be divided into two layers based on the degree of fissure.
Each of the random allocation classes will be performed with hex blocks using a random number table.
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
Sabzevar University of Medical Sciences Ethics Committee
Street address
No. 55, First Floor, Dentist 19, Mashhad, Dental Boulevard,
City
Sabzevar
Province
Razavi Khorasan
Postal code
09189855793
Approval date
2019-11-16, 1398/08/25
Ethics committee reference number
IR.MEDSAB.REC.1398.068
Health conditions studied
1
Description of health condition studied
Breast fissure
ICD-10 code
O92.1
ICD-10 code description
Cracked nipple associated with pregnancy, the puerperium, and lactation
Primary outcomes
1
Description
Severity of breast fissure
Timepoint
Before intervention,Third day after intervention,Seventh day after intervention
Method of measurement
Standard Store Scale
Secondary outcomes
1
Description
Severity of breast pain
Timepoint
Before intervention,Third day after intervention,Seventh day after intervention
Method of measurement
Standard Visual Pain Scale
Intervention groups
1
Description
Intervention group 1: Mothers were asked to apply erythromycin gel as much as one finger three times daily on the nipple and the surrounding aura,Intervention group 2: Place the breast protector on the nipple before breastfeeding and hold it while sucking.
Category
Treatment - Other
2
Description
Control group: The mothers were instructed to pour three or four drops of breast milk on each nipple and aura after each lactation and allow it to dry.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Breastfeeding Clinic
Full name of responsible person
Mojdeh Navinejad
Street address
first floor, No. 13, Shirin dead end, 45 Ibn Yamin Street, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Phone
+98 21 4423 5198
Email
mojdemw@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshte Ghorat
Street address
Above the Memorial of Unknown MartyrsCampus of Sabzevar University of Medical Sciences, Boulevard Shohadaye hastei, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 21 4401 8363
Email
drghorat@gmail.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mojdeh Navinejad
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
first floor, No. 13, Shirin dead end, 45 Ibn Yamin Street, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Phone
+98 51 4423 3808
Email
mojdemw@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mojdeh Navinejad
Position
Master of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
first floor, No. 13, Shirin dead end, 45 Ibn Yamin Street, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Phone
+98 21 4423 3808
Email
mojdemw@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Shojaee
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Midwifery
Street address
First floor, No. 55, Dentists 19, Dental Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
09189855793
Phone
+98 21 3509 9349
Email
Fateme.sh7752@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available