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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breastfeeding; Human Milk
• Intervention / Treatment: Device: milking pump

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 5, 2022
• Primary Completion (Anticipated): June 15, 2022
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: breastfeeding; breast milk; human milk; milk contents
• Other Study ID Numbers: mineis001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No