NCT04593719

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

October 6, 2020

Last Update Submit

October 13, 2020

Conditions

Keywords

Cesarean sectionBreastfeedingMother milkLactation management modelBreastfeeding training

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

EXPERIMENTAL

Lactation management model is applied to the experimental group.

Other: Experiment

Control

NO INTERVENTION

Lactation 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).

Experiment

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen were chosen as it was a study related to breast milk and breastfeeding.
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

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: 27635741BACKGROUND
  • ACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006.

    PMID: 30575678BACKGROUND
  • 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.

    PMID: 27684560BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 27118118BACKGROUND
  • Eker 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.

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Aslı EKER

    Mersin University

    PRINCIPAL INVESTIGATOR

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

Locations