Clinical Research Directory

Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia

The goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency. The main questions it aims to answer are: 1. What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials? 2. What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status? 3. How do iodine and iron interact with each other to affect thyroid function in the mother during lactation? Participants will be randomized to receive a daily multiple micronutrient tablet containing iodine (UNIMAPP) for 6 months postpartum, or routine postnatal care per Ethiopia Ministry of Health. Mothers will provide a breast milk sample and blood at 3 and 6 months postpartum. Infants will provide a urine sample and drop of blood, and have a neurodevelopmental assessment at 3 and 6 months. Researchers will compare the groups that received the iodine-containing micronutrient supplement with the group that received routine care and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.

Alcohol, Breast Cancer, and Metabolism

Alcohol consumption, even at low levels, has been associated with increased breast cancer risk, but the biological mechanisms underlying this relationship remain unclear. This study will examine whether breast tissue may locally metabolize alcohol by measuring alcohol-related compounds in paired blood and breast milk samples from lactating women. The findings may help clarify alcohol-related biological pathways relevant to breast cancer risk and improve risk communication.

Evaluation of a Wearable Technology to Support Breastfeeding Women

This study aims to evaluate a wearable technology developed to support breastfeeding women. The study will assess the performance of sensors in the wearable prototype for monitoring breast milk fullness and milk flow and compare the sensor measurements with the amount of breast milk obtained through breast pumping. The study will also evaluate women's experiences, satisfaction, perceived usefulness, and ease of use of the wearable prototype and its mobile application. The technology is intended for monitoring and support purposes and will not be used for diagnosis, treatment, or clinical decision-making.

Pasteurised Donor Human Milk Supplementation for Term Babies

PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy. There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \[including anxiety and depression symptoms and health-related quality of life\] along with infant cow's milk allergy symptoms.

The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition

Breast milk is considered the gold standard for infant nutrition thanks to its ability to provide adequate nutrition and a high amount of protective factors for the baby's health. According to the guidelines of the World Health Organization (WHO), exclusive feeding with breast milk should be conducted until the end of 6 months of life and should be continued in the following months with the simultaneous introduction of complementary foods. Several evidence demonstrates that breast milk intake is associated with positive health outcomes, both during infancy and later in the life. Given the protective role of breast milk for the health of the child and the future adult, studying its content is of fundamental importance to have an integrated vision of the biological effects of its components on the child health, and of the factors that are able to modulate its composition. The "Building a Deeper Knowledge on Breast Milk Composition" (BuKoBc) project was designed to study the content of human milk in its entirety and at different times during the feeding and day, also in relation to environmental factors capable of modulating its composition. The results of this study may provide data on optimal reference ranges for nutrient intake in breastfed infants and may provide guidance for defining optimal nutrient intake for infants who cannot be breastfed. Furthermore, the in-depth study of the environmental factors capable of influencing the composition of breast milk will allow the development of nutritional intervention strategies for the breastfeeding mother in order to positively modulate the composition of her milk.

Mediterranean Diet on Postpartum Depression

Optimal maternal nutrition and mental well-being are important for successful breastfeeding and maternal and infant health. The objective of this randomized controlled study was to evaluate the effect of a Mediterranean diet intervention on postpartum depressive symptoms in breastfeeding mothers and on infant growth. Breastfeeding mothers attending a well-child clinic for their infants' routine immunization were screened using the Edinburgh Postnatal Depression Scale (EPDS). Mothers who were breastfeeding an infant younger than 1 year and had an EPDS score of ≥12 were eligible for the study. A total of 60 eligible mothers were enrolled and randomized to either a Mediterranean diet intervention group or a control group. Participants were followed for 3 months.

Social Media and Risk Reduction Teaching-Enhanced Reach

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).

Breastfeeding Stories and Video Education in Primiparous Mothers

The Effect of Successful Breastfeeding Stories and Video-Based Education on Breastfeeding Self-Efficacy and Breastfeeding Success in Primiparous Mothers: A Randomized Controlled Trial Objective: This study was planned to determine the effect of the combined use of audio recordings based on successful breastfeeding stories and video-based breastfeeding education on breastfeeding self-efficacy and breastfeeding success among primiparous mothers. Methods: This study will be conducted using a randomized controlled experimental design. The population of the study will consist of primiparous mothers who give birth at the Obstetrics and Gynecology Clinic of Koç University Hospital between September 2026 and February 2027. The sample will consist of a total of 70 primiparous mothers (35 intervention and 35 control) who meet the inclusion criteria and are assigned to the intervention and control groups using a computer-assisted simple randomization method. In addition to routine breastfeeding education provided at the hospital, mothers in the intervention group will receive audio recordings based on successful breastfeeding stories and video-based breastfeeding education. The control group will receive only the routine breastfeeding education provided at the hospital. Data will be collected using the Descriptive Characteristics Form, Postpartum Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), LATCH Breastfeeding Assessment Tool, Educational Materials Satisfaction Form, and First-Month Evaluation Form. Data will be analyzed using SPSS version 25.0. Descriptive statistics, independent-samples t-test, paired-samples t-test, chi-square test, and repeated-measures analysis of variance (ANOVA) will be used. The statistical significance level will be accepted as p\<0.05. Expected Results: It is anticipated that the audio recordings based on successful breastfeeding stories and the video-based education program will increase breastfeeding self-efficacy and breastfeeding success among primiparous mothers. Conclusion: The findings obtained from this study are expected to contribute to the planning of evidence-based nursing interventions aimed at improving breastfeeding self-efficacy and breastfeeding success among primiparous mothers, provide a scientific basis for innovative educational models that can be used to support breastfeeding, and guide the development of standardized breastfeeding education programs that can be implemented in postpartum care services.

Breastfeeding Education Integrated With Web Portal and Mobile Application-Supported Counseling

Breastfeeding provides significant benefits for maternal and infant health; however, perceived insufficient milk supply is one of the most common factors associated with early breastfeeding discontinuation. Although the World Health Organization recommends exclusive breastfeeding for the first six months of life, breastfeeding continuation rates remain suboptimal in many countries, including Türkiye. This randomized controlled trial aims to evaluate the effect of breastfeeding education combined with a web portal and mobile application-supported breastfeeding counseling on perceived insufficient milk supply, breastfeeding intention, and breastfeeding adaptation among pregnant women. Women at 37-39 weeks of gestation will be randomly assigned to an intervention group or a control group. Participants in the intervention group will receive individualized breastfeeding education during pregnancy, educational materials, postpartum breastfeeding support, and web portal- and mobile application-supported breastfeeding counseling. Participants in the control group will receive routine hospital care. Data will be collected during pregnancy (baseline), immediately after birth, and at 1-, 3-, and 6-month postpartum follow-ups using validated scales assessing perceived insufficient milk supply, breastfeeding intention, and breastfeeding adaptation. Digital platform usage data, including the counseling topics accessed and the frequency of use, will also be evaluated in the intervention group. This study is supported as a research project and aims to develop an accessible digital breastfeeding support model that may improve breastfeeding confidence, reduce perceived insufficient milk supply, and promote breastfeeding adaptation and continuation.

Social Transfers for Exclusive Breastfeeding in Brazil

The goal of this study is to assess the effectiveness of social transfers on exclusive breastfeeding rates in São Paulo, Brazil. The main research questions are: 1. Are social transfers effective at increasing exclusive breastfeeding rates 2. Are social transfers effective in prolonging the duration of exclusive breastfeeding 3. Are social transfers effective in prolonging the duration of complementary breastfeeding 4. What are the long-term impacts of social transfers for breastfeeding on child health and development Participants will be randomly assigned to one of three groups: 1) control, no social transfer 2) non-conditional social transfer at 6-months postpartum, and 3) conditional social transfer at six months postpartum; conditional upon the mothers exclusive breastfeeding status. All participants receive education about the benefits of exclusive breastfeeding and current international recommendations. Researchers will compare the intervention groups to the control group to see if social transfers are effective at increasing exclusive breastfeeding rates at six months postpartum.

Social Transfers for Exclusive Breastfeeding

The goal of this study is to assess the effectiveness of social transfers on exclusive breastfeeding rates in Lao PDR. The main questions it aims to answer are: 1. Are social transfers effective at increasing exclusive breastfeeding rates at 6-months 2. Are social transfers cost-effective 3. What are the long-term impacts of social transfers for breastfeeding on child development Participants will be randomly assigned to one of three groups: 1) control, no social transfer 2) non-conditional social transfer at 6-months postpartum, and 3) conditional social transfer at six months postpartum; conditional upon the mothers exclusive breastfeeding status. All participants receive education about the benefits of exclusive breastfeeding and current international recommendations. Researchers will compare the intervention groups to the control group to see if social transfers are effective at increasing exclusive breastfeeding rates at six months postpartum.

A Study of Melatonin Concentration During Lactation

This research is being done to understand better how a mother's emotional well-being and lifestyle, such as her levels of stress, fatigue, depression, anxiety, sleep quality, and eating habits, might affect the levels of melatonin and sIgA in her breast milk.

Evaluation of the Effect of Active Warming Applied to the Mother During Cesarean Section on Post-Breastfeeding Outcomes: A Randomized Controlled Study

Hypothermia is a complication of cesarean section and a cause of breastfeeding problems. Preventing maternal hypothermia is one of the goals of the enhanced postoperative recovery (ERAS) protocol and is important for the health of both mother and baby. This clinical trial aims to determine the effects of active warming during and after cesarean delivery on breastfeeding outcomes, thermal comfort, and perceived insufficient milk supply. The primary questions it aims to answer are: 1. To evaluate the effect of active warming during cesarean delivery on mothers' perception of thermal comfort. 2. To evaluate the effect of active warming after cesarean delivery on mothers' perceived insufficient milk supply. 3. To determine the effect of active warming after cesarean delivery on breastfeeding success. Participants: Warming will be provided using an active warming bed during cesarean delivery (45 minutes). Warming will continue in the postpartum care unit (45 minutes). The control group will not receive any warming and will receive the hospital's standard care procedure.

Breastfeeding Self-Efficacy Theory-Based Education and Counseling in Pregnant Adolescents

Adolescence is the period between the ages of 10 and 19, during which individuals undergo physiological, biological, psychological, and social development, transitioning from childhood to adulthood. Pregnancies occurring during this period are defined as adolescent pregnancies. In developing countries, approximately 21 million adolescent pregnancies occur annually among individuals aged 15-19, resulting in around 12 million births. According to national demographic data, a certain percentage of adolescent women have already started childbearing. Pregnancies occurring during this stage, when physical and psychosocial development is still incomplete, bring various medical and social challenges. Adolescent pregnancies are associated with increased maternal and fetal mortality and morbidity risks and are classified as high-risk pregnancies. Therefore, adolescent mothers require close follow-up during both the antenatal and postpartum periods. However, studies indicate that adolescent mothers often fail to attend regular antenatal check-ups, receive inadequate education on breastfeeding, and consequently feel unprepared for motherhood. They tend to have low breastfeeding self-efficacy and develop negative attitudes toward breastfeeding. In the postpartum period, they also experience difficulties in initiating and maintaining breastfeeding. Research highlights the need for education and counseling for adolescent mothers during the antenatal and postpartum periods. Providing education on breastfeeding is particularly important for improving maternal and infant health outcomes. Current approaches to breastfeeding counseling involve face-to-face training provided by healthcare professionals in medical institutions, as well as various alternative methods such as home visits, online/web-based education portals, theory-based training, text messages, emails, and phone consultations. In breastfeeding counseling, it is essential to not only provide education but also ensure continuous follow-up. Monitoring the process is expected to increase adolescent mothers' breastfeeding self-efficacy, foster positive attitudes toward breastfeeding, and extend the duration of breastfeeding. This study aims to assess the effects of antenatal education based on the Breastfeeding Self-Efficacy Theory and postpartum follow-up counseling on adolescent mothers' breastfeeding attitudes and self-efficacy. By enhancing their breastfeeding self-efficacy and attitudes, this study is expected to contribute to resolving challenges related to early initiation and continuation of breastfeeding in the postpartum period.

Review of Infant Oral Feeding and Skills

This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral feeding.

Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants

Preterm infants are at increased risk of vitamin A deficiency because they are born with low vitamin A stores and depend largely on breast milk to meet their nutritional needs. This study will evaluate whether daily maternal vitamin A supplementation increases vitamin A concentrations in the breast milk of mothers who deliver infants before 29 weeks of gestation. Participants will receive a commercially available oral multivitamin supplement containing 1,300 mcg retinol activity equivalents (RAE) of vitamin A daily for four months after delivery. Breast milk samples will be collected at 2 weeks, 2 months, and 4 months postpartum to measure vitamin A concentrations. The study will assess whether maternal supplementation is a feasible approach for increasing breast milk vitamin A concentrations in mothers of preterm infants.

Milk Production and Body Weight Response to Suggested Protocol in Obese Lactating Women

This study will investigate the milk production and body weight response of both mother and the newborn to aerobic exercise in obese lactating women.

Postpartum Vaginal Estrogen for Breastfeeding Patients

Sexual dysfunction is very common in the postpartum period and is more common in people who breastfeed or pump. This research study was designed to help determine whether postpartum patients who use vaginal estrogen cream while breastfeeding have improved sexual function compared to postpartum patients who do not.

Effectiveness of Breastfeeding Education Using a Lactation Simulation Model Among Nursing Students: A Randomized Controlled Trial

Breastfeeding education provided by nurses is an important determinant of breastfeeding success and maternal breastfeeding self-efficacy. Nursing students should acquire effective breastfeeding counseling skills before entering clinical practice. Simulation-based education offers students the opportunity to develop communication and clinical skills in a safe learning environment. The aim of this randomized controlled trial was to evaluate the effectiveness of breastfeeding education using a lactation simulation model among fourth-year nursing students. Students were randomly assigned to either an intervention group receiving simulation-based breastfeeding education using a lactation simulation model or a control group receiving routine theoretical breastfeeding education. During their maternity clinical placement, students provided standardized breastfeeding education to postpartum mothers. The primary outcomes were students' breastfeeding education skills and maternal breastfeeding self-efficacy. Secondary outcomes included breastfeeding success assessed by the LATCH Breastfeeding Assessment Tool and students' educational satisfaction. The findings of this study are expected to provide evidence supporting the integration of simulation-based breastfeeding education into undergraduate nursing curricula.

Kangaroo Care: Breastfeeding Success and Maternal Role

Purpose: This is a randomized controlled trial designed to investigate the effects of Intermittent Kangaroo Mother Care (KMC) in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role. Methodology and Sample: Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026. Sample Size: Based on G\*Power analysis (alpha=0.05, power=80%, effect size d=0.548), a total of 108 mothers will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org. Intervention: Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for intermittent Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported. Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support). Data Collection Tools: Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).

Grandparent Breastfeeding Education and Breastfeeding Outcomes

Lactation is the period when new mothers breastfeed their babies and milk production is at its highest level. During this period, breast milk, as a natural source of nutrition, provides the baby with the necessary nutrients for the first six months following birth. Globally, 44% of newborns are breastfed within the first hour, and 40% are exclusively breastfed for the first six months. The goal is to increase these rates to 70% for breastfeeding within the first hour and to over 50% for exclusive breastfeeding for the first six months. According to the 2018 Turkish Population and Health Survey (TNSA), the rate of breastfeeding within the first hour of newborns was determined to be 71%, and the rate of exclusive breastfeeding for the first six months was 41%. Although breastfeeding is common in our country, breastfeeding rates are not at the level recommended by the World Health Organization. One of the factors that may cause a decrease in breastfeeding initiation and maintenance rates is inadequate support and management of breastfeeding . The older generation often plays an important role in supporting breastfeeding behavior. In traditional Turkish families, an experienced older generation is willing to have a say in breastfeeding behaviors such as initiating and maintaining breastfeeding. In the international literature, it is also reported that grandmothers guide mothers in matters such as taking care of the mother and baby, initiating and maintaining breastfeeding, giving the first milk to the baby, the mother's nutrition during the breastfeeding period, and the timing of the transition to complementary foods. Among the positive effects of grandmother support are; The benefits of grandmother support include strengthening mothers' decisions to start and continue breastfeeding by sharing information and experience about breastfeeding and increasing mothers' ability to continue breastfeeding. reported that grandmother support significantly affected mothers in the postpartum period. However, negative effects of grandmother support have also been reported. Some studies show that grandmothers may negatively affect breastfeeding duration because they recommend giving extra fluids to infants in the first months of life or encourage the early introduction of complementary foods. Studies show that grandmother support can affect mothers' breastfeeding behaviors in both positive and negative ways. However, there are no randomized controlled trials in the literature that examine the effect of guiding grandmother support with a scientifically structured educational program on the breastfeeding process, maternal motivation, and breastfeeding self-efficacy. In this context, the aim of this research is to determine how breastfeeding education given to grandmothers during the prenatal period affects mothers' motivation regarding the breastfeeding process, breastfeeding self-efficacy, and breastfeeding continuation.

The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success

Although the female body and fetus are physiologically equipped to carry out the birthing process, the increasing medical interventions in the birthing process today are pushing women into the background during labor. This situation can indirectly affect the duration of labor by causing an increase in women's anxiety and perceived pain levels. In this regard, the application of non-pharmacological methods that support women in effectively managing pain, enabling their active participation in childbirth, shortening the duration of the stages of labor, and having low cost and side effects, stands out as an important care option for women. Today, the use of non-pharmacological methods by midwives who play an active role in childbirth and postpartum care is becoming increasingly common. Among the non-pharmacological approaches are distraction techniques; Practices such as deep breathing exercises, early skin-to-skin contact, listening to relaxing music, watching videos, virtual reality applications, communicating, or cognitive focus shifting contribute to a woman's perception of her birthing experience as more controllable and comfortable . This research will be conducted to evaluate the effect of music listening and stress ball application on placental separation time, pain during episiotomy repair, and breastfeeding success in primiparous pregnant women.

Pumping to Up Maternal Milk Production for Preterms

The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is: \- What effect does pumping frequency have on breast milk supply. Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce. Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.

Early Life Exposures Among Children With Sickle Cell Disease

This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.