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Postpartum WomenMLIHVNCT07163871

Breastfeeding, Maternal Functioning, and Resilience

A study testing Postpartum hygiene, breast milk, and breastfeeding education have been provided for new mothers. in people with Postpartum Women, run by Medine Yönder at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Women
What is being tested?
Postpartum hygiene, breast milk, and breastfeeding education have been provided for new mothers.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Feb 2025to 20 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult
  • 18 yaş ve üzerinde,
  • Primipar,
  • Miadında doğum yapmış,
  • Sağlıklı tek bebek dünyaya getiren,
  • Psikiyatrik bir tanı almamış olan,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kahramanmaraş Sütçü Imam Univercity

    Kahramanmaraş, 46100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Individualized Home Visits Under the Supervision of Midwives on Maternal Functioning, Breastfeeding, and Resilience: a Randomized Controlled Trial

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

Read the detailed description

Childbirth is one of the most unique and important events in a woman's life. The postpartum period is defined as the period that begins immediately after childbirth and ends six weeks later. The period corresponding to the first twenty-four hours is called the immediate period; the period from the first twenty-four hours to the end of the first week is called the early period; and the period from the second week after childbirth to the end of the sixth week is called the late period. We can say that the postpartum period is a critical period for women, newborns, and other family members. For primiparous women, it is a very challenging process that requires adaptation to new roles and brings with it emotional, physical, social, and spiritual changes and confusion.

The postpartum period is also a transition period during which women and family members must adapt to new physical, psychological, and social circumstances In many developed countries, the hospital stay after vaginal delivery is typically less than 48 hours during this transition period. In Turkey, the hospital stay for the mother and newborn is a maximum of 24 hours after a normal birth and 48 hours after a cesarean section . However, this period is quite short in terms of providing education related to the postpartum period, monitoring potential complications, and addressing psychological issues. In this context, home visits are of great importance for the early detection and intervention of difficulties faced by women who cannot access adequate healthcare services, for educating them on how to care for themselves and their babies, and for providing other personal care services. Home visits during the postpartum period contribute to the protection and improvement of the mother's health by providing technical, psychological, and therapeutic support regarding her care, education, and needs at home.

The World Health Organization (WHO) recommends at least four follow-up visits for all mothers and newborns within six weeks after birth. These should be conducted on the 1st day (first 24 hours), 3rd day (48-72 hours), 7-14th days, and 30-42nd days . It is believed that face-to-face physical examinations and/or screenings of the mother and newborn are more effective during these follow-ups. Midwives can provide personalized postpartum care through home visits tailored to the needs of the mother and newborn. Midwife-led postpartum care is an important public health intervention for women, newborns, and other family members . Midwife-led postpartum home visits can increase awareness among mothers regarding breastfeeding initiation, breastfeeding continuation, manual milk expression and proper milk storage, family planning and postpartum contraception, lochia monitoring, home hygiene, and newborn care .

Unfortunately, there is currently no strong evidence that home visits improve postpartum maternal and infant health, and there is a need for evidence-based research on these topics . Research on midwife-led postpartum home visits and home care is not at the desired level. A Swedish study examining the postpartum care experiences of first-time mothers after discharge from the hospital showed that midwives played a supportive role and increased parents' self-confidence . A Norwegian study on women's experiences of home visits by midwives in the early postpartum period identified three main themes: relational continuity, postpartum conversation, and vulnerability . A study conducted in the UK found that pregnancy, childbirth, and postpartum care were associated with improved health outcomes for women and babies in socially disadvantaged and diverse communities. A home visitation program conducted in Australia for vulnerable families in disadvantaged areas demonstrated improvements in participants' parenting skills and well-being, participation in community networks, and access to support services . In Sweden, vulnerable women who received long-term home visits reported improved parenting skills and increased confidence when discussing issues with professionals . A longitudinal study investigating the impact of home visits in Germany also reported improvements in the skills of mothers receiving care in areas such as newborn care, managing family relationships, and seeking, receiving, and accepting external help .

Becoming a mother is a physiological process in which behaviors specific to women and different from the norm are observed. The transition to motherhood can be considered an important developmental event in a woman's life . The process of assuming the role of motherhood should begin during pregnancy and continue until the birth of the baby . Although the role of motherhood begins during pregnancy, it truly begins after the baby is born, when the mother becomes aware of her maternal functions, roles, and responsibilities through interaction with the baby . The success of the maternal role indicates the quality of parenting behaviors and has a significant impact on the social development of the newborn. The formation of maternal identity also contributes to a woman's psychosocial development .

Breastfeeding is one of the actions that not only affects the growth and development of the baby but also the health of the family and society . Breastfeeding provides babies with the nutrients they need for healthy growth and development in the best possible way. The World Health Organization (WHO) recommends that mothers exclusively breastfeed their children for the first six months of life and continue breastfeeding with complementary foods until the age of two or beyond. However, approximately 40% of infants worldwide are exclusively breastfed during the first six months of life . At the national level in Turkey, this rate is similar. Breastfeeding rates among women are influenced by many factors, including sociodemographic characteristics, psychosocial factors, attitudes toward breastfeeding, knowledge about breastfeeding, and self-efficacy in breastfeeding .

Women may experience some psychological distress due to the effects of postpartum hormones. The most common psychological disorder during this period is postpartum depression. Postpartum depression is defined as a mood disorder that can last from the first 2-4 weeks after birth to the first year . Although it cannot be attributed to a single cause, it is thought to be caused by genetic predisposition, hormonal imbalances, and psychological and physiological factors during this process . The symptoms of postpartum depression vary from mother to mother, but they can include sleep problems, inability to enjoy life, unexplained weight loss, feelings of inadequacy, guilt, tension, and thoughts of suicide . When considering the causes of postpartum depression, unexpected health problems, insufficient social support, health problems in the newborn, a history of psychiatric illness, the type of delivery, the number of births, and, in addition, the woman's birth experience, how she perceives the birth, and how she records it in her memory are among the influencing factors.

Similar studies have been conducted in the literature. Bostancı Daştan and colleagues examined the mental health of pregnant women through home visits and emphasized that pregnancy can cause crisis and that depression symptoms should be detected as early as possible. Erenel and Eroğlu conducted an experimental study to determine the effect of a breastfeeding education model supported by home visits in the early postpartum period on effective breastfeeding behavior. They found that a large proportion of the women participating in the study continued effective breastfeeding, while the rate of effective breastfeeding in the control group was much lower. In the experimental study conducted by Demir Yıldırım and Hotun Şahin, it was determined that home visits during pregnancy monitoring were an effective model in increasing pregnant women's knowledge about the prenatal period, their desire for vaginal delivery, and the duration of initial and subsequent breastfeeding. However, no study has been found in the literature regarding the effect of individualized home visits on maternal function, breastfeeding attitudes, and depression levels. The aim of this planned study is to support the postpartum care process conducted at the primary care level through home visits led by midwives and to observe its effect through a control group. The home visits are intended to increase satisfaction with the services provided during the postpartum period, ensure the provision of quality postpartum care, and thereby minimize the risk of bleeding and infection and facilitate adaptation to motherhood. In addition, the aim is for women to receive the necessary education about the postpartum period, to perform postpartum self-care appropriately, to meet the feeding and care needs of the newborn, to increase their self-efficacy in breastfeeding, and to minimize the risk of postpartum depression.

Being tested
Postpartum hygiene, breast milk, and breastfeeding education have been provided for new mothers.
Keywords
breastfeeding, midwifery, postpartum depression, home visit
Medical subject headings
Breast Feeding, Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postpartum hygiene, breast milk, and breastfeeding education have been provided for new mothers.Behavioural

    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.

Study groups in NCT07163871
Study groupRoleWhat they receive
intervention groupExperimentalThis group was given detailed information on postpartum hygiene, breastfeeding, baby care, breast milk, and other necessary topics.
Receives: Behavioral: Postpartum hygiene, breast milk, and breastfeeding education have been provided for new mothers.
control groupNo interventionNo training other than routine postnatal training has been provided. No intervention has been made.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 week

Secondary outcomes (2)
  1. Infant Feeding Attitude Scale

    The Infant Feeding Attitude Scale was developed to assess women's attitudes toward breastfeeding and to estimate the duration of breastfeeding as well as the choice of infant feeding method (de la Mora et al. 1999). The scale consists of 17 items on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Nine items on the scale relate to breast milk, and eight items relate to formula milk. Formula milk items are reverse-scored (1=5, 2=4, 4=2, and 5=1). The total attitude score ranges from 17 to 85 points. The Cronbach's alpha coefficient of the scale was found to be 0.86 (de la Mora et al., 1999). The validity and reliability of the scale in Turkish were established by Ekşioğlu and colleagues (2016). The Cronbach's alpha internal consistency coefficient of the scale was determined to be 0.71 (Ekşioğlu et al., 2016). In this study, the Cronbach's alpha internal consistency coefficient of the scale was calculated as 0.72.

    Measured: 2 week

  2. Edinburgh Postpartum Depression Scale

    The validity and reliability of the scale in Turkish were established by Engindeniz, and the Cronbach's alpha value of the scale was determined to be 0.79 (Engindeniz, 1996). The scale is used to determine the risk of depression in the postpartum period and to measure changes in its level and severity. The EPDÖ is a self-assessment scale consisting of 10 items that reflect the individual's psychological state over the past seven days. Each item is scored on a 0-3 scale with a four-point Likert scale: "Yes, always," "Yes, most of the time," "No, not very often," and "No, never." The lowest possible score on the scale is 0, and the highest possible score is 30. Items 1, 2, and 4 are scored as 0, 1, 2, 3, while items 3, 5, 6, 7, 8, 9, and 10 are scored in reverse as 3, 2, 1, 0. The cutoff point for the EPDÖ is calculated as 12/13, and the total score indicates the severity of depression.

    Measured: 2 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start4 Feb 2025
  3. Primary completion4 Feb 2025
  4. Study completion20 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
One group received training, while the other group was surveyed without receiving training.
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07163871
Sponsor's protocol ID
Hatice Gül ÖZTAŞ
Acronym
MLIHV
Status last verified
Oct 2026
First submitted
19 Aug 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Postpartum hygiene, breast milk, and breastfeeding education have been provided for new mothers. in people with Postpartum Women, run by Medine Yönder at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Barkin Maternal Function Scale (time frame: 2 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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