LactationNCT04593719
Effect of Lactation Management Model on Breastfeeding Process
A study testing Experiment in people with Lactation and Breastfeeding, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Background: While caesarean sections are increasing, breast-feeding rates are decreasing. It is important to implement supportive programs to ensure mothers breast feed for the desired period and infants are fed by only mother's milk. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation, Breastfeeding, Cesarean Section
- What is being tested?
- Experiment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2017to 31 Oct 2018
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- to be between 18-35 years old,
- being in the 30th week of pregnancy,
- 36th week or above with planned caesarean delivery,
Who cannot join
- risky pregnancy (multiple gestation, Preeclampsia etc.),
- breast operation history,
- health issues of mother or baby that may affect breast feeding process,
- medication use that may affect milk production,
- communication problems related to language,
- failure to be reached via phone after discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lactation Management Model on Breastfeeding Process After Cesarean
Background: While caesarean sections are increasing, breast-feeding rates are decreasing. It is important to implement supportive programs to ensure mothers breast feed for the desired period and infants are fed by only mother's milk.
Aim: In the research, it was aimed to evaluate the effects of lactation management models on mothers' breastfeeding process following a caesarean section.
Read more
Methods: The research was conducted as a randomized controlled study and experimentally. Before implementation, Lactation Management Model was developed. Data collection was performed during gestation, first day after postpartum, pre-discharge, on 9th day in face to face interview and in the form of monthly phone interviews up to 6 months. While the experimental group exercised lactation management model, control group received routine lactation practices in clinic.
Conclusions: Among the females in the experimental group, it was found that breastfeeding self-efficacy were higher, and breastfeeding techniques were accurate and successful and breastfeeding only and continuity rates were higher while breastfeeding related breast problems developed less frequently. Lactation management model should be used and expanded to increase breastfeeding rates.
Keywords: Cesarean section, breastfeeding, mother milk, lactation management model, breastfeeding training
Read the detailed description
It is a birth right of babies to be breast fed and nursed. However, approximately 7.6 million babies cannot be fed with breast milk in the world every year. United Nations International Children's Emergency Fund (UNICEF) declared in its statement that, breast milk access is decreased as household income increases and in nations with high income 1 out of every 5 babies and for low or middle income nations 1 of every 25 babies never fed breast milk (UNICEF, 2018). Worldwide, among the infants under six months old, 40% is fed with breast milk only (UNICEF, 2017). According to Turkey Demographic and Health Survey data, it is found that in Turkey; breast milk feeding rate of infants under 6 months is 41% and in average breast milk feeding period is 1.8 months (TNSA, 2018).
There are many factors affecting whether an infant is breastfed. Delivery method is among one of them. While in OECD nations and in UNITED STATES OF AMERICA 32% of every delivery was caesarean (Health İndicators, 2018; ACOG, 2019), in Turkey this rate is indicated as 52% (TNSA, 2018). Caesarean delivery compared to vaginal delivery is negatively affecting the initial lactation period, milk production and suckling instinct of the infant (Hobbs et al., 2016). Esencan et al. has determined that 42.4% of women who had spinal-caesarean deliveries did not breast feed (Esencan et al., 2018).
Numerous factors are in effect for suckling and milk production. Various studies are performed in the literature it is emphasized that in order to stimulate and increase the milk production; apart from evidence based applications, breast stimulation and other techniques to cure nursing problems should be employed (Anderson et al., 2016). Becker et al. In their systematical compositions; determined that actions such as; resting, music, applying warmth to breast area, massaging, pump aided stimulations increased milk production clinically in a significant manner (Becker et al., 2016). Although applying warmth to breast area, massaging and relaxations techniques for increasing milk production and ensuring long term breast feeding are evidently lacking in the international manuals; early nursing, skin-to-skin contact together with education and support is stated to be positively affecting breast feeding (WHO, 2017; NICE, 2015). Despite all these actions taken national and international breast feeding data still is not at a favorable level. Because initiation of lactation contuniuty and increase in the period of breastfeeding depends on many factors. Education of mother starting from gestational period; care, support and consultancy services should be provided during pregnancy, birth and postpartum periods. This study has been planned in consideriation with the need for a model that includes all this service, maintenance and support, no similar study has been found in the literature that has all these components together.
- Conditions
- Lactation, Breastfeeding, Cesarean Section
- Being tested
- Experiment
- Keywords
- Cesarean section, Breastfeeding, Mother milk, Lactation management model, Breastfeeding training
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentOther
The main components of the Lactation Management Model; breastfeeding training in the prenatal period (from the 30th week of pregnancy), early postpartum period (first 48 hours) skin to skin contact, early breastfeeding, relaxation using a dreaming technique, warm application to the breast, breast massage and for the first 48 hours after postpartum 6 months of continuous support (face to face, by phone, via social media).
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Lactation management model is applied to the experimental group. Receives: Other: Experiment |
| Control | No intervention | Lactation management model is not applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation of Breastfeeding and Only Breast Milk
Women who are applied lactation management model feed their babies with only breast milk at a higher rate (Measured using Breastfeeding and breastmilk monitoring form.It is a form developed by the researcher, consisting of 4 open-ended questions for the purpose of continuing breastfeeding and breastfeeding and determining additional nutrients other than breast milk).
Measured: 6 month
Breastfeeding Observation Form Scores at Postpartum in The First 48 Hours
It was determined that women who were applied the Lactation Management Model were able to breastfeed successfully with the appropriate technique (Measured using the Breastfeeding observation form. developed by Armstrong form consists of 25 parameters under 5 main titles. For each parameter, "Percentage of Success" is calculated by taking the frequencies of 0, 1 and 2 scores. "Successful Technique" is indicated as between 46-50 points and "Insufficient Technique" as 45 and below).
Measured: The First 48 Hours
Secondary outcomes (2)
Latch Scale Scores and Breast Nipple-Related Discomfort Levels Related to Breastfeeding
It was found that problems related to the nipple develop less in women who were applied lactation management model (Measured using A breastfeeding charting system and documentation tool. Developed by Jensen et al. scale consists of 5 assessment criteria. Each item has a score of between 0 and 2, and highest score is 10).
Measured: First 9 days
Breastfeeding Self-Efficacy Scale Scores
Breastfeeding self-efficacy was higher in women who were applied the Lactation Management Model (Measured using Breastfeeding Self-Efficacy Scale Scores. It was developed by Dennis and is a 5-point Likert type scale. Minimum 14 points and maximum 70 points can be obtained from the scale. A higher score indicates that an increase in breastfeeding self-efficacy).
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start11 Nov 2017
- Primary completion18 Jul 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LactationStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı EKER, Mersin University
- Investigators
- Aslı EKER, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593719
- Sponsor's protocol ID
- Lactation-Management-Model
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson L, Kynoch K, Kildea S. Effectiveness of breast massage in the treatment of women with breastfeeding problems: a systematic review protocol. JBI Database System Rev Implement Rep. 2016 Aug;14(8):19-25. doi: 10.11124/JBISRIR-2016-003058.
PubMed 27635741ACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006.
PubMed 30575678Becker GE, Smith HA, Cooney F. Methods of milk expression for lactating women. Cochrane Database Syst Rev. 2016 Sep 29;9(9):CD006170. doi: 10.1002/14651858.CD006170.pub5.
PubMed 27684560Esencan YT, et al. Type of delivery, time of ınitial breastfeeding, and skin-to-skin contact of pregnant women participating in childbirth preparation education. Florence Nightingale Journal of Nursing 2018; 26(1): 31-43.
Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.
PubMed 27118118Eker A, Aslan E. Effect of Lactation Management Model on Breastfeeding Process After Cesarean: A Prospective Randomized Controlled Study. Reprod Sci. 2024 Apr;31(4):1108-1116. doi: 10.1007/s43032-023-01409-3. Epub 2023 Dec 14.
PubMed 38097898
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactation Management Model on Breastfeeding Process After Cesarean
- ClinicalTrials.gov ID
- NCT04593719
- Acronym / sponsor ID
- Lactation-Management-Model
- Conditions
- Lactation, Breastfeeding, Cesarean Section
- Keywords
- Cesarean section, Breastfeeding, Mother milk, Lactation management model, Breastfeeding training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 20 Oct 2020 (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.
Background: While caesarean sections are increasing, breast-feeding rates are decreasing. It is important to implement supportive programs to ensure mothers breast feed for the desired period and infants are fed by only mother's milk.
Aim: In the research, it was aimed to evaluate the effects of lactation management models on mothers' breastfeeding process following a caesarean section.
Methods: The research was conducted as a randomized controlled study and experimentally. Before implementation, Lactation Management Model was developed. Data collection was performed during gestation, first day after postpartum, pre-discharge, on 9th day in face to face interview and in the form of monthly phone interviews up to 6 months. While the experimental group exercised lactation management model, control group received routine lactation practices in clinic.
Conclusions: Among the females in the experimental group, it was found that breastfeeding self-efficacy were higher, and breastfeeding techniques were accurate and successful and breastfeeding only and continuity rates were higher while breastfeeding related breast problems developed less frequently. Lactation management model should be used and expanded to increase breastfeeding rates.
Keywords: Cesarean section, breastfeeding, mother milk, lactation management model, breastfeeding training
Detailed description
It is a birth right of babies to be breast fed and nursed. However, approximately 7.6 million babies cannot be fed with breast milk in the world every year. United Nations International Children's Emergency Fund (UNICEF) declared in its statement that, breast milk access is decreased as household income increases and in nations with high income 1 out of every 5 babies and for low or middle income nations 1 of every 25 babies never fed breast milk (UNICEF, 2018). Worldwide, among the infants under six months old, 40% is fed with breast milk only (UNICEF, 2017). According to Turkey Demographic and Health Survey data, it is found that in Turkey; breast milk feeding rate of infants under 6 months is 41% and in average breast milk feeding period is 1.8 months (TNSA, 2018).
There are many factors affecting whether an infant is breastfed. Delivery method is among one of them. While in OECD nations and in UNITED STATES OF AMERICA 32% of every delivery was caesarean (Health İndicators, 2018; ACOG, 2019), in Turkey this rate is indicated as 52% (TNSA, 2018). Caesarean delivery compared to vaginal delivery is negatively affecting the initial lactation period, milk production and suckling instinct of the infant (Hobbs et al., 2016). Esencan et al. has determined that 42.4% of women who had spinal-caesarean deliveries did not breast feed (Esencan et al., 2018).
Numerous factors are in effect for suckling and milk production. Various studies are performed in the literature it is emphasized that in order to stimulate and increase the milk production; apart from evidence based applications, breast stimulation and other techniques to cure nursing problems should be employed (Anderson et al., 2016). Becker et al. In their systematical compositions; determined that actions such as; resting, music, applying warmth to breast area, massaging, pump aided stimulations increased milk production clinically in a significant manner (Becker et al., 2016). Although applying warmth to breast area, massaging and relaxations techniques for increasing milk production and ensuring long term breast feeding are evidently lacking in the international manuals; early nursing, skin-to-skin contact together with education and support is stated to be positively affecting breast feeding (WHO, 2017; NICE, 2015). Despite all these actions taken national and international breast feeding data still is not at a favorable level. Because initiation of lactation contuniuty and increase in the period of breastfeeding depends on many factors. Education of mother starting from gestational period; care, support and consultancy services should be provided during pregnancy, birth and postpartum periods. This study has been planned in consideriation with the need for a model that includes all this service, maintenance and support, no similar study has been found in the literature that has all these components together.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: ExperimentLactation management model is applied to the experimental group. |
| Control | No intervention | –Lactation management model is not applied to the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- to be between 18-35 years old,
- being in the 30th week of pregnancy,
- 36th week or above with planned caesarean delivery,
Key exclusion criteria (6 listed)
- risky pregnancy (multiple gestation, Preeclampsia etc.),
- breast operation history,
- health issues of mother or baby that may affect breast feeding process,
- medication use that may affect milk production,
- communication problems related to language,
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 |
|---|---|---|
| ExperimentThe main components of the Lactation Management Model; breastfeeding training in the prenatal period (from the 30th week of pregnancy), early postpartum period (first 48 hours) skin to skin contact, early breastfeeding, relaxation using a dreaming technique, warm application to the breast, breast massage and for the first 48 hours after postpartum 6 months of continuous support (face to face, by phone, via social media). | Other | Experiment |
Primary outcome
Continuation of Breastfeeding and Only Breast Milk
Time frame: 6 month
Women who are applied lactation management model feed their babies with only breast milk at a higher rate (Measured using Breastfeeding and breastmilk monitoring form.It is a form developed by the researcher, consisting of 4 open-ended questions for the purpose of continuing breastfeeding and breastfeeding and determining additional nutrients other than breast milk).
Breastfeeding Observation Form Scores at Postpartum in The First 48 Hours
Time frame: The First 48 Hours
It was determined that women who were applied the Lactation Management Model were able to breastfeed successfully with the appropriate technique (Measured using the Breastfeeding observation form. developed by Armstrong form consists of 25 parameters under 5 main titles. For each parameter, "Percentage of Success" is calculated by taking the frequencies of 0, 1 and 2 scores. "Successful Technique" is indicated as between 46-50 points and "Insufficient Technique" as 45 and below).
2 secondary outcomes
Latch Scale Scores and Breast Nipple-Related Discomfort Levels Related to Breastfeeding
Time frame: First 9 days
Breastfeeding Self-Efficacy Scale Scores
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Background: PubMed 27635741Anderson L, Kynoch K, Kildea S. Effectiveness of breast massage in the treatment of women with breastfeeding problems: a systematic review protocol. JBI Database System Rev Implement Rep. 2016 Aug;14(8):19-25. doi: 10.11124/JBISRIR-2016-003058.
- Background: PubMed 30575678ACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006.
- Background: PubMed 27684560Becker GE, Smith HA, Cooney F. Methods of milk expression for lactating women. Cochrane Database Syst Rev. 2016 Sep 29;9(9):CD006170. doi: 10.1002/14651858.CD006170.pub5.
- BackgroundEsencan YT, et al. Type of delivery, time of ınitial breastfeeding, and skin-to-skin contact of pregnant women participating in childbirth preparation education. Florence Nightingale Journal of Nursing 2018; 26(1): 31-43.
- Background: PubMed 27118118Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.
- Derived from this study: PubMed 38097898Eker A, Aslan E. Effect of Lactation Management Model on Breastfeeding Process After Cesarean: A Prospective Randomized Controlled Study. Reprod Sci. 2024 Apr;31(4):1108-1116. doi: 10.1007/s43032-023-01409-3. Epub 2023 Dec 14.
- UNİCEF For Every Child, Breastfeeding A Mother's Gift, for Every Child 2018Link provided by the sponsor.
- WHO, Protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services guideline 2017Link provided by the sponsor.
- NİCE. Postnatal care up to 8 weeks after birth clinical guideline 37Link provided by the sponsor.
- Health IndicatorsLink provided by the sponsor.
- 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.
Aslı EKER principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiment in people with Lactation and Breastfeeding, run by Mersin University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Continuation of Breastfeeding and Only Breast Milk (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593719, which also lists 6 linked publications.
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 20 Oct 2020.