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

Not Applicable

• Conditions: Breastfeeding; Human Milk
• Interventions: Device: milking pump

• Registration Number: NCT05401123
• Lead Sponsor: Gazi University

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.

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 Timeline

• Study First Submitted: 2022-04-21
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Study Start: 2022-06-05
• Primary Completion: 2022-06-15
• Study Completion: 2022-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand	milking pump	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

Primary Outcome Measures

Name	Time	Method
The protein contents will be analyzed by Miris®️ HMA	12 week	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.
The ph contents will be analyzed by Miris®️ HMA	12 week	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.
The carbohydrate contents will be analyzed by Miris®️ HMA	12 week	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.