Effect of Lactation Management Model on Breastfeeding Process
1 other identifier
interventional
66
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedFirst Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedOctober 20, 2020
October 1, 2020
8 months
October 6, 2020
October 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Latch Scale Scores and Breast Nipple-Related Discomfort Levels Related to Breastfeeding
First 9 days
Breastfeeding Self-Efficacy Scale Scores
2 month
Study Arms (2)
Experiment
EXPERIMENTALLactation management model is applied to the experimental group.
Control
NO INTERVENTIONLactation management model is not applied to the control group.
Interventions
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).
Eligibility Criteria
You may qualify if:
- to be between 18-35 years old,
- being in the 30th week of pregnancy,
- th week or above with planned caesarean delivery,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mersin University
Yenişehir, Mersin, Turkey (Türkiye)
Related Publications (6)
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.
PMID: 27635741BACKGROUNDACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006.
PMID: 30575678BACKGROUNDBecker 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.
PMID: 27684560BACKGROUNDEsencan 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.
BACKGROUNDHobbs 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.
PMID: 27118118BACKGROUNDEker 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.
PMID: 38097898DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aslı EKER
Mersin University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer Doctor
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 20, 2020
Study Start
November 11, 2017
Primary Completion
July 18, 2018
Study Completion
October 31, 2018
Last Updated
October 20, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share