BreastfeedingNCT05401123
Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand
A study testing milking pump in people with Breastfeeding and Human Milk, run by Gazi University.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Human Milk
- What is being tested?
- milking pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Breastfeeding, Human Milk
- Being tested
- milking pump
- Keywords
- breast milk, breastfeeding, milk contents, human milk
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milking pumpDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: milking pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start5 Jun 2022 (estimated)
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- breasting pump
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Yaman Sözbir, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401123
- Sponsor's protocol ID
- mineis001
- Status last verified
- May 2022
- First submitted
- 21 Apr 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand
- ClinicalTrials.gov ID
- NCT05401123
- Acronym / sponsor ID
- mineis001
- Conditions
- Breastfeeding, Human Milk
- Keywords
- breast milk, breastfeeding, milk contents, human milk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (estimated)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- breasting pump
| Arm | Type | Receives |
|---|---|---|
| Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand | Experimental | Device: milking pumpRandomization 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 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| milking pumpn 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. | Device | Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand |
Primary outcome
The protein contents will be analyzed by Miris®️ HMA
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing milking pump in people with Breastfeeding and Human Milk, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The protein contents will be analyzed by Miris®️ HMA (time frame: 12 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.