Clinical Research Directory

Correcting Breastfeeding Myths, Knowledge, Self-efficacy and Practices

This study aims to evaluate and compare the effectiveness of a face-to-face intervention program and a tele-lactation intervention program on breastfeeding myths, knowledge, self-efficacy, and practices among primiparous mothers. Participants will be assigned to receive either face-to-face or tele-lactation guidance and support. Breastfeeding knowledge, self-efficacy, and practices will be assessed to determine the impact of each approach on improving outcomes for first-time mothers

Effect of Beeswax-Based Nipple Protector and Breast Milk on Nipple Problems

Breastfeeding is the optimal method of infant feeding and provides significant health benefits for both mothers and infants. However, nipple pain, tenderness, fissures, and other nipple-related problems are common during the early postpartum period and frequently lead to breastfeeding difficulties or early discontinuation. Although various interventions, including breast milk, lanolin, and hydrogel dressings, have been used to prevent nipple trauma, there is still no consensus regarding the most effective approach. Beeswax possesses moisturizing, antimicrobial, anti-inflammatory, and wound-healing properties and may represent a safe and natural alternative for preventing nipple damage. However, evidence regarding the effectiveness of beeswax-based nipple protectors remains limited. This study aims to evaluate the effectiveness of a beeswax-based nipple protector compared with routine breast milk application in preventing nipple problems among postpartum breastfeeding mothers. The study will be conducted as a prospective, randomized controlled trial in a university hospital. Postpartum mothers who meet the inclusion criteria will be randomly assigned to either the intervention group, which will use a beeswax-based nipple protector, or the control group, which will receive routine breast milk application. Participants will be followed during the first 20 postpartum days. Data will be collected using a descriptive information form, a breast assessment form, the Visual Analogue Scale for pain, and the Breastfeeding Self-Efficacy Scale-Short Form. Assessments will be performed at baseline and on postpartum days 10 and 20. Statistical analyses will be conducted using appropriate descriptive and comparative methods according to data distribution, and repeated measurements will be analyzed using longitudinal statistical models. This study is expected to provide evidence regarding the effectiveness of a beeswax-based nipple protector in reducing nipple pain and trauma and improving breastfeeding self-efficacy.

An Innovative Continuum of Care to Promote Exclusive Breastfeeding

Malnutrition and non optimal breastfeeding is one the the major cause of high infant morbidity and mortality in a developing country like Pakistan. In addition low women literacy rate,socioeconomic factors, cultural limitations,poor excess to information, misconceptions and other factors has led to low breastfeeding rates. There has also been a shift over time from home based care and delivery to antenatal care from skilled providers and deliveries within health care facilities. Which is an opportunity to strengthen breastfeeding counselling to mothers starting from health facility where mothers come for antenatal visits and by utilising other modes of counselling within the health facility (which have weak or non-existing structured breast feeding program) and when mothers home till 6 months as a continuous support. Women from different backgrounds have opportunity to get excess to complete information on benefits,misconceptions and myths of breastfeeding which is understandable and acceptable by her, to enable her to make an informed decision to initiate early, exclusively breastfeed and to continue breastfeeding till 2 years or beyond. The intervention group will receive interventions, will include a family member as a support for participant in her breastfeeding, 2 sessions of counselling on breastfeeding during participants antenatal visits,sharing of readable booklet \& video messages on Whats App application of cell phones about breastfeeding, hands on training by nurse after delivery, and continuum of support by multiple visits of lady health workers when the mothers home till 6 months. It will also include training of doctor,nurse \& lady health workers involved in the intervention. The content of intervention will contain benefits \& ideal breastfeeding practices, latching \& feeding positions,expression \& storage of breast milk, associated myths \& difficulties with solutions in breastfeeding. The control group participants will receive the routine support on breastfeeding given in hospital and in the community. Feasibility, acceptability, cost effectiveness, sustainability and effectiveness of the intervention will be assessed.

Effect of Su Jok Therapy on Breastfeeding

There are many alternative methods to increase breast milk. In the literature, studies on Su Jok therapy applications are limited and no studies on increasing breast milk have been found. In Korean language, 'Su' means hand and 'Jok' means foot. Su Jok therapy is defined as a modern acupressure/acupuncture interpretation that utilises the body's independent communication systems on the hands and feet by applying various techniques such as massage, moxa (heating), needles, magnets and seeds to the reflection points on the hands and feet. Su Jok is an integrated therapy that incorporates many tried and trusted methods of oriental medicine

Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women

This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms: * Arm A: Single-dose rifampicin at 10 mg/kg body weight (RIF10). * Arm B: Single-dose rifampicin at 20 mg/kg body weight (RIF20). * Arm C: Single-dose isoniazid at 5 mg/kg body weight (INH5). * Arm D: Single-dose levofloxacin at 10-15 mg/kg body weight (LFX10-15). * Arm E: Single-dose rifapentine at 10 mg/kg body weight (RPT10). * Arm F: Single-dose bedaquiline at 400 mg (BDQ400).

Maximising Maternal Milk for Preterm Infant

Maternal milk is the gold standard in infant nutrition, providing significant advantages, in preterm and term infants. Maternal milk plays a major role in reducing the risk of inflammatory bowel disease(NEC) in premature and low birth weight infants as well as improving neurodevelopmental outcomes in this population, In this study the investigators are comparing earlier (from birth rather than 48 hours post delivery) use of an electrical breast pump. Mothers will be selected at random to be in one of two groups: early or later pump use. The investigators will compare milk volumes achieved on day 14 post delivery between the two groups. The investigators will recruit x number of mothers of preterm infants \< 33 weeks gestation at birth

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.

The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels

Effect of Hybrid Breastfeeding Education on Breastfeeding Effectiveness and Postpartum Comfort

Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy

This randomized controlled trial aims to evaluate the effects of an artificial intelligence (AI)-based chatbot developed to address breastfeeding problems on mothers' breastfeeding attitudes, behaviors, and self-efficacy. The study will also assess exclusive breastfeeding rates, breastfeeding duration, and the technical performance and usability of the developed chatbot. The study is planned to include 92 primiparous mothers allocated to intervention and control groups. The intervention involves an AI-based breastfeeding counseling chatbot developed using natural language processing (NLP) and Retrieval-Augmented Generation (RAG) technology. The chatbot will provide evidence-based breastfeeding education, information, and counseling support using an expert-reviewed breastfeeding knowledge base. The system is designed to support mothers in managing breastfeeding-related difficulties and will not provide medical diagnoses or replace healthcare professionals. Breastfeeding attitudes, self-efficacy, and behaviors will be evaluated during the postpartum follow-up period. Assessments will be conducted at baseline and at the first, third, and sixth postpartum months. Exclusive breastfeeding rates and breastfeeding duration will also be assessed. Additionally, the chatbot's technical performance, response reliability, medical safety, user satisfaction, and usability will be evaluated. The study aims to provide scientific evidence regarding the effectiveness and feasibility of an AI-supported, evidence-based breastfeeding counseling intervention.

Methyl Donor-Rich Diet in the Postpartum Period

This study aims to evaluate the effects of a methyl-donor-rich diet during the postpartum period on maternal depression, breastfeeding success, and infant weight. Postpartum women will first complete a three-day dietary record to assess their intake of selected nutrients involved in one-carbon metabolism, including folate, choline, betaine, methionine, vitamin B6, and vitamin B12. Women whose intake of at least one of these nutrients is below two-thirds of the applicable reference intake and who meet the other eligibility criteria will be eligible to participate. Eligible participants will be randomly assigned to one of two groups. The intervention group will receive an individualized methyl-donor-rich dietary program and nutrition education for two months. The control group will receive standard postpartum care and routine dietary advice. The study will compare the groups in terms of maternal depressive symptoms, breastfeeding success, and infant weight. Dietary intake will also be assessed.

Postpartum Care in the NICU Multi-Site Breastfeeding

Parents of infants in the neonatal intensive care unit (NICU) face unique barriers to long-term breastfeeding and lactation. The physical and emotional demands of having a critically ill or premature newborn combined with the stress, sleep deprivation, and separation inherent to the NICU environment make it difficult for many mothers to sustain breastfeeding and lactation, even when they want to. At the same time, NICU mothers are at elevated risk for post-traumatic stress disorder (PTSD) and poor health-related quality of life, which can further undermine lactation success and overall maternal wellbeing. PeliCaN Multi-Site Breastfeeding tests whether a trained postpartum doula, working directly in the NICU can improve breastfeeding and lactation outcomes and support maternal mental health through 6 months postpartum. Participants are enrolled during their infant's NICU hospitalization to receive either doula support or standard care, depending on the study site condition at the time of enrollment (control vs. intervention). Mothers in the intervention group will receive lactation education and support, and emotional and informational support from a NICU-informed doula for up to 6 months. Mothers in the usual care group receive standard NICU clinical care, including access to NICU lactation consultants, without study doula support. All participants complete surveys at enrollment and at 6 months postpartum covering infant feeding practices, maternal mental health, and demographic characteristics. The study asks two primary questions: (1) Does NICU-informed postpartum doula support improve breastfeeding and lactation rates at 6 months? (2) Does doula support improve health-related quality of life and reduce post-traumatic stress disorder symptoms at 6 months? A subset of intervention participants, NICU staff, and lactation consultants will also participate in qualitative interviews and brief implementation surveys to assess how well the doula program works in practice across participating sites.

KULEA-NET: A Mobile Application for African American/Black Mothers to Promote Exclusive and Continuous Breastfeeding

KULEA-NET is a mHealth intervention that will improve knowledge, self-efficacy, and intentions related to exclusive breastfeeding (EBF). These factors have been demonstrated to have a positive influence on breastfeeding (BF) initiation and duration among African American/Black (AA/B) mothers. In the long term, KULEA-NET has great potential to achieve increased BF initiation and EBF rates among AA/B mothers and as a result, improved maternal and infant health outcomes.

Effects of Maternal and Infant Massage on Breastfeeding and Mother-Infant Bonding

This study aims to evaluate the effects of different massage techniques applied to mothers and infants on breastfeeding parameters and mother-infant bonding during the postpartum period. The study will investigate whether infant massage applied by mothers, oxytocin massage applied to mothers by fathers, or the combination of both interventions improves breastfeeding outcomes and mother-infant bonding compared with standard postpartum care.

Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting. The main questions it aims to answer are: * Does listening to a relaxation audiorecording during breastfeeding improve infant growth? * Does listening to a relaxation audiorecording during breastfeeding reduce maternal stress and anxiety? Researchers will compare listening to an audiorecording on a digital recording device to receiving the digital recording device without an audiorecording to see if relaxation audiorecordings work to improve breastfeeding, infant growth and maternal well-being. Participants will: * Listen to an audiorecording twice daily while breastfeeding for 12 weeks * Have study visits at 1, 2, 4 and 12 weeks for checkups and tests * Let us know what they think of the audiorecording

The Effect of Model-based Education on Breastfeeding Self-efficacy and Success

This study was designed as a randomised, pretest-posttest study, assessing breastfeeding self-efficacy and breastfeeding in first-time mothers following a separate video and podcast training session using the Health Action Process Approach Model. The study will be conducted with primiparous pregnant women in their third trimester, with no restrictions on breastfeeding. In the first phase of the study, a semi-trained interview format based on the SESY Model will be administered to 15 pregnant women at a fertility school to address nutritional deficiencies. Deficiencies in the pregnant women will be identified. To address these deficiencies, the researcher will develop a breastfeeding education book based on the SESY Model, produce a video, and produce the same content as a podcast. Both groups will complete the Introductory Information Form, the Breastfeeding Attitudes Assessment Scale, and the Breastfeeding Self-Efficacy Scale-Short Form. After completing their surveys, the control groups, which are pregnant women, will only receive the Breastfeeding Brochure from the Ministry of Health of the Republic of Turkey. Pregnant women in the intervention groups receive breastfeeding education throughout the cycle, in addition to videos and podcasts. Pregnant women will be asked to watch the videos and listen to the podcast until they give birth. Pregnant women will be contacted on the day of their birth to ask if there are any websites they would like to learn more about and to re-watch the video and listen to the podcast. Pregnant women will be contacted for an evaluation one month after birth to complete the Breastfeeding Attitudes Assessment Scale, Breastfeeding Self-Efficacy Scale-Short Form, LATCH Breastfeeding Diagnostic and Assessment Scale, and Breastfeeding Follow-Up Form I. To emphasize the importance of breastfeeding in the first six months and ensure continuity of breastfeeding, pregnant women will be contacted again at six months to complete a post-test and the Breastfeeding Attitudes Assessment Scale, Breastfeeding Self-Efficacy Scale-Short Form, LATCH Breastfeeding Diagnostic and Assessment Scale, and Breastfeeding Follow-Up Form II.

Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi

The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among post-partum women and its implementation into existing clinical care models in Lilongwe, Malawi. The main question the study seeks to answer is: Do women at clinics implementing the LINK model have improved Pre-exposure Prophylaxis (PrEP) persistence compared to women at clinics receiving the standard of care? Researchers will compare the LINK model to standard of care by randomizing twelve sites to either the LINK model or the standard of care. Then researchers will review existing medical record and health surveillance data, and qualitative and quantitative data collected from intervention and control sites.

Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)

This study is about preparing women with excessive weight to have better breastfeeding outcomes. By doing this study, the investigators hope to learn more about how hand expression of breast milk or colostrum during pregnancy can help prepare a mother to breastfeed after she has her baby and about how her diet affects the composition of her breast milk and her baby's growth and development.

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).

Midwife-Led Digital Follow-Up After Cesarean Section

This randomized controlled trial aims to evaluate the effect of a midwife-led digital follow-up program on postpartum depression, perceived social support, and breastfeeding self-efficacy in women who will undergo cesarean section. Participants will be randomly assigned to either an intervention group that will receive structured face-to-face education followed by a 4-week digital follow-up program, or a control group that will receive routine postpartum care. Data will be collected at baseline (postpartum day 1), at 1 week, and at 4 weeks postpartum using validated measurement tools. The study will provide evidence on the effectiveness of continuous, midwife-led digital support in improving maternal psychological well-being and breastfeeding outcomes in the early postpartum period.

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.