Clinical trial NCT04593719: Effect of Lactation Management Model on Breastfeeding Process
Official title: Effect of Lactation Management Model on Breastfeeding Process After Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation
Breastfeeding
Cesarean Section
Keywords: Cesarean section
Breastfeeding
Mother milk
Lactation management model
Breastfeeding training
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuation of Breastfeeding and Only Breast Milk
timeFrame: 6 month
measure: Breastfeeding Observation Form Scores at Postpartum in The First 48 Hours
timeFrame: The First 48 Hours
Secondary outcomes:
measure: Latch Scale Scores and Breast Nipple-Related Discomfort Levels Related to Breastfeeding
timeFrame: First 9 days
measure: Breastfeeding Self-Efficacy Scale Scores
timeFrame: 2 month
Other outcomes:
Locations:
city: Yenisehir
country: Turkey
facility: Mersin University
state: Mersin
Study officials:
affiliation: Mersin University
name: Aslı EKER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: ACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006.
citation: Becker 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.
citation: Esencan 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.
citation: 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.