CClinicalTrials.gg
Status unknownNCT05401123Updated Jun 2, 2022

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

An interventional study of milking pump in Breastfeeding and Human Milk, sponsored by Gazi University. Status unknown. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-02.

Sponsored by Gazi University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breastfeeding
  • Human Milk

Keywords

  • breast milk
  • breastfeeding
  • milk contents
  • human milk
03

In context

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • 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

Interventions

  • Devicemilking 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 week

  2. 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.

    Time frame: 12 week

  3. 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.

    Time frame: 12 week

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05401123
Lead sponsor
Gazi University
Responsible party
Şengül Yaman Sözbir (associate oroffesor, Gazi University) — Principal investigator
First posted
Jun 2, 2022
Start date
Jun 5, 2022 (estimated)
Primary completion
Jun 15, 2022 (estimated)
Completion
Jul 15, 2022 (estimated)
Last update
Jun 2, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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