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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05401123
Other study ID # mineis001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 5, 2022
Est. completion date July 15, 2022

Study information

Verified date May 2022
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The researchers planned this study to compare the effects of breast pumps, which are frequently used today, and manual milking after manual massage on the change in milk content when breast and breastfeeding problems develop.


Description:

Comparison of the methods used to solve the milk secretion and breastfeeding problems of the participants in the postpartum period; effective and uncomplicated methods should be put forward. Today, breast milk is expressed by hand using massage or pumps. Both milking techniques used have positive and negative aspects. While there are studies showing that breast milk content is affected by the milking techniques used, there are also studies showing that it does not. This study by the researchers was planned to compare the effects of post-massage pumps and manual milking on the change in milk content. For this reason, it is thought that the researchers will contribute to the literature scientifically and, since it is a doctoral thesis, it can be a guide for future studies on the subject.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date July 15, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: Between the ages of 20-35 - Postpartum 1-5. between the day - Those who gave birth after the 37th week of pregnancy - The baby does not have any condition that prevents sucking - Those whose baby is not hospitalized in the neonatal intensive care unit - Those who do not have literacy problems, mental disabilities and communication problems - Mothers who agreed to participate in the study voluntarily Exclusion Criteria: Those who want to quit working voluntarily - Inaccessible, cut off communication during operation - Mothers whose babies were hospitalized during the study - Hospitalized during the study - Not completing study post-tests - Who does not do any milking for a day - Mothers who express only once a day for two consecutive days

Study Design


Related Conditions & MeSH terms


Intervention

Device:
milking pump
n the study, all mothers who come to the Lactation/Relactation outpatient clinic will be informed about the study, and mothers who accept the study will have to fill out the "Conformity to Criteria Form" created by the researcher. Between the ages of 20-35, postpartum 1-5. Participants who gave birth after the 37th week of pregnancy, did not have literacy problems, mental disabilities and communication problems, did not have chronic diseases, did not use any medication, and volunteered to participate in the study will be included in the study. by milking, 2 ml of first milk will be taken from the participants in the control group (via the milking pump). The collected milk will be taken to the laboratory for analysis by the researcher.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Outcome

Type Measure Description Time frame Safety issue
Primary The protein contents will be analyzed by Miris®? HMA Breast milk expressed by hand or by pumping. Milks will defrize, then, will warm and will homogenize using Miris Ultrasonic Processor for 5 seconds, and analyzed for protein content performing MirisĀ®? HMA. analyzes breast milk content. The results of protein contents will be recorded in the breast milk analysis form. 12 week
Primary The ph contents will be analyzed by Miris®? HMA Breast milk expressed by hand or by pumping. Milks will defrize, then, will warm and will homogenize using Miris Ultrasonic Processor for 5 seconds, and analyzed for ph content performing MirisĀ®? HMA. The results of ph contents will be recorded in the breast milk analysis form. 12 week
Primary The carbohydrate contents will be analyzed by Miris®? HMA Breast milk expressed by hand or by pumping. Milks will defrize, then, will warm and will homogenize using Miris Ultrasonic Processor for 5 seconds, and analyzed for carbohydrate contents, it will be recorded in the breast milk analysis form. 12 week
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