Effect of Lactation Management Model on Breastfeeding Process

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Lactation Management Model on Breastfeeding Process After Cesarean

Conditions
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Lactation, Breastfeeding, Cesarean Section

Intervention / Treatment
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* Other: Experiment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: to be between 18-35 years old, being in the 30th week of pregnancy, 36th week or above with planned caesarean delivery, Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experiment<br>Lactation management model is applied to the experimental group. | Other: Experiment<br>* 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).<br>|
| No Intervention: Control<br>Lactation management model is not applied to the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | The First 48 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Breastfeeding, Mother milk, Lactation management model, Breastfeeding training