NCT07163871

Brief Summary

This study aims to examine the effect of individualized home visits led by midwives on maternal functioning, breastfeeding attitudes, and depression levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 19, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
Last Updated

September 9, 2025

Status Verified

July 1, 2025

Enrollment Period

Same day

First QC Date

August 19, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

breastfeedingmidwiferypostpartum depressionhome visit

Outcome Measures

Primary Outcomes (1)

  • Barkin Maternal Function Scale

    It was developed by Barkin in 2009 to assess functional status during the postpartum period. The validity and reliability study of the Turkish version of the scale was conducted by Aydın and Kukulu (2016) (Aydın, Kukulu, 2016). The scale consists of 16 items divided into five subscales: self-care (3 items), maternal psychology (2 items), infant care (4 items), social support (3 items), and adjustment to motherhood (4 items). The items on the scale are 7-point Likert-type and numbered from 0 to 6. The responses are as follows: 0 "I completely disagree," 1 "I disagree," 2 "I somewhat disagree," 3 "I am undecided," 4 "I somewhat agree," 5 "I agree," and 6 "I completely agree." The lowest possible score on the scale is 0, and the highest possible score is 96 (Aydın \& Kukulu, 2018). A high score on the scale indicates that the individual has a high level of maternal functioning. In Aydın and Kukulu's study, the Cronbach's alpha reliability coefficient of the scale was found to be 0.73.

    2 week

Secondary Outcomes (3)

  • LATCH Breastfeeding Assessment Scale

    2 week

  • Infant Feeding Attitude Scale

    2 week

  • Edinburgh Postpartum Depression Scale

    2 week

Study Arms (2)

intervention group

EXPERIMENTAL

This group was given detailed information on postpartum hygiene, breastfeeding, baby care, breast milk, and other necessary topics.

Behavioral: Postpartum hygiene, breast milk, and breastfeeding education have been provided for new mothers.

control group

NO INTERVENTION

No training other than routine postnatal training has been provided. No intervention has been made.

Interventions

During the first ten days after birth, the first month, and the third month, new mothers received detailed care and education through home visits in addition to routine postnatal education. Information was shared at the mother's request as needed.

intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is being conducted on women who have recently given birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)
* 18 yaş ve üzerinde, * Primipar, * Miadında doğum yapmış, * Sağlıklı tek bebek dünyaya getiren, * Psikiyatrik bir tanı almamış olan,

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü Imam Univercity

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingDepression, Postpartum

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: One group received training, while the other group was surveyed without receiving training.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc Student

Study Record Dates

First Submitted

August 19, 2025

First Posted

September 9, 2025

Study Start

February 4, 2025

Primary Completion

February 4, 2025

Study Completion

July 20, 2025

Last Updated

September 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations