Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand

NCT05401123 | Unknown DMC

• 1 other identifier: mineis001
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breastfeeding; Human Milk

Keywords

breast milk; breastfeeding; milk contents; human milk

Outcome Measures

Primary Outcomes (3)

• 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 Miris®️ HMA. analyzes breast milk content. The results of protein contents will be recorded in the breast milk analysis form.

  12 week

• 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 Miris®️ HMA. The results of ph contents will be recorded in the breast milk analysis form.

  12 week

• 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

Study Arms (1)

Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand

EXPERIMENTAL

Randomization In order to ensure similarity between groups; Stratified block randomization was used to assign the women in the sample group to the experimental and control groups. According to the stratified block randomization method, the imbalances that may occur in the experimental and control groups are limited. In this method, block randomization is performed within each stratum after stratification according to risk factors (Akın \& Koçoğlu, 2017; Kanık, Taşdelen \& Erdoğan, 2011). Since the mode of delivery affects the content of breast milk, women will be divided into two layers as vaginal delivery and cesarean section in terms of delivery type (Table 1). In order to determine the strata group of the woman who was found to meet the research criteria and accepted to participate in the study, a list of assignments was created through the website www.randomizer.org by making 6 blocks with a combination of 4 . Experiment: A Control: B

Device: milking pump

Interventions

milking pump DEVICE

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.

Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate oroffesor

Model Details: breasting pump

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: June 2, 2022
• Study Start: June 5, 2022
• Primary Completion: June 15, 2022
• Study Completion: July 15, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share