Clinical Research Directory

Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and Breastfeeding Success

The postpartum period is a critical time marked by significant physiological and psychosocial changes that can affect sleep, emotional well-being, and breastfeeding behaviors. Previous studies indicate that mode of delivery and sleep quality are closely associated with breastfeeding outcomes, with cesarean birth often linked to poorer sleep and lower breastfeeding success. Evidence also suggests that postpartum sleep disturbances are related to reduced breastfeeding self-efficacy, lower motivation, fatigue, depressive symptoms, and shorter breastfeeding duration. However, the literature lacks studies that evaluate insomnia severity, breastfeeding motivation, and breastfeeding success simultaneously-particularly during the first 48 hours after birth. This analytical study aims to assess insomnia severity, breastfeeding motivation, and breastfeeding success (LATCH) within the first 48 postpartum hours and to examine the relationships among these variables. Findings are expected to support early postpartum clinical interventions to improve maternal and infant health outcomes.

Postnatal Exercise to Activate Baby's Brown Fat

The purpose of this study is to learn how exercise and physical activity during pregnancy and after pregnancy may affect the composition of breastmilk. Certain changes in breast milk after exercise may have an impact on how infants use energy. Understanding this process may improve public health recommendations for exercise during and after pregnancy. This study can help investigators learn more about how maternal exercise patterns may affect body growth and obesity risk in infants who are breastfed. This research may help identify how different factors can influence healthy weight and early development in infants.

Postpartum Acupressure Education and Breastfeeding Outcomes

This randomized controlled trial evaluates whether acupressure education provided to mothers within the first 48 hours postpartum improves exclusive breastfeeding rates at 6 months compared with standard postpartum care alone. Mothers in the intervention group will receive structured education on self-administered acupressure at selected points and will be encouraged to continue home-based practice, while the control group will receive standard breastfeeding support. Participants will be followed for 12 months to assess breastfeeding continuation, breastfeeding self-efficacy, breastfeeding quality, and breastfeeding-related outcomes.

Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU

The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.

Medicines in Breast Milk and Estimated Infant Exposure

The MedMilk (Medication concentrations in human Milk) study investigates how selected medicines taken by breastfeeding women are transferred into human milk and whether this may affect the breastfed child. The study includes breastfeeding women who are already using prescription or over-the-counter medicines as part of their usual care. Participants provide samples of breast milk and urine and complete a questionnaire about maternal and infant health. The collected data will be used to quantify medicine concentrations in milk and estimate the relative infant dose. The study aims to contribute new data to support safer prescribing and more informed counselling during breastfeeding

Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood

The goal of this clinical trial is to compare two different forms of postnatal care to find out which is most beneficial for mothers and their children after birth and with which they are most satisfied. One is a nurse-led, seperate model of care and the other is a midwife-led, integrative model of care. Participants are healthy women between the ages of 18 and 50. They gave birth between 36+0 and 42+0 weeks of pregnancy and had a child. The type of birth is not an inclusion or exclusion criteria. Our hypotheses are: i) that maternal satisfaction with care in a midwife-led, integrative care model is higher than in separate maternal and infant care; ii) that a positive postpartum experience leads to earlier and increased maternity competence; iii) that a higher breastfeeding rate at the time of the survey in the fourth month can be achieved through integrative care. Participants will be randomly assigned, after birth of their child, to either the group cared for by a nurse or the group cared for by a midwife.

The Impact of Acute Exercise in the Heat on Breast Milk Production and Composition in Lactating Women

This clinical trial aims to determine whether heat stress alters 24-hour breast milk production and composition following an acute bout of exercise in the heat among lactating women. The main questions are: 1. To ascertain whether heat stress alters 24-hour breast milk production following acute exercise in the heat among lactating women. We hypothesize that breast milk production will decrease to a greater extent following acute exercise in the heat compared to acute exercise with no heat stress. Lactating mothers will complete an acute exercise bout at 40% of their peak oxygen consumption (VO2peak) for 60 mins in a hot (36 °C, 40% relative humidity) and thermoneutral environment (20 °C, 20% relative humidity). Participants will record their total breast milk production in a 24-hour period using an infant scale. 2. to discover whether heat stress impacts the energy composition of breast milk following acute exercise in the heat among lactating women. We hypothesize that energy density will decrease to a greater extent following acute exercise in the heat compared to acute exercise with no heat stress. Participants will use a manual expression breast pump to collect 10 mL of breast milk from each breast immediately and 24 hours post-exercise. Energy density (lactose, protein, and lipid content) will be assessed via enzyme-linked immunosorbent assays. Participants will complete the following visits: 1) initial consent visit 2) baseline testing; 3) acute exercise in the hot condition (HOT; 36C, 40% relative humidity), and 4) acute exercise in the temperate, thermoneutral condition (TEMP; 20C, 20% relative humidity). The baseline testing day will measure participant anthropometrics including height, weight, and body composition measured by a DEXA scan. For both experimental trials, participants will be asked to walk on a treadmill at based on their metabolic heat production (8W/kg) for 60 minutes. Heart rate (HR), mean skin temperature (Tsk), core temperature (Tcore), sweat loss (SL), and fluid intake will be measured throughout the exercise protocol. Breast milk composition will be measured through milk expression using a manual expression breast pump immediately and 24 hours post-exercise. Participants will log their breast milk production for 24 hours following the exercise using an infant scale to measure their infants before and after each feed.

Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium

Pharmacotherapy for lactating women in Hungary presents a unique challenge. While certain medications may pose risks to the infant or reduce breast milk production, the unnecessary avoidance of treatment can also be harmful. Despite this, no dedicated Hungarian website currently provides guidance on the safe use of over-the-counter (OTC) medications for breastfeeding mothers. To address this gap, the aim is to develop a website that not only meets clinical standards but also presents essential information in a clear, accessible format that helps mothers understand and retain key details by choosing the best medium. Our main question is: What is the most effective way to educate lactating women about OTC medication use through an online platform?

Effects of Laughter Therapy on Postpartum Mothers' Stress, Sleep, and Breastfeeding

Postnatal period is an important developmental transition period for women. Stress in the postnatal period is one of the most common mental health problems and most mothers report experiencing stress in the perinatal period. In addition, stress and negative mental health also threaten breastfeeding self-efficacy. The postnatal period is an important stage in terms of early initiation and maintenance of breastfeeding. Breastfeeding self-efficacy is a mother's perceived confidence in her ability to breastfeed her newborn baby. Therefore, midwives are expected to assess women and identify women in need of supportive interventions and consciously contribute to their treatment. Another common problem in the postnatal period is poor sleep quality. It was determined that an increase in sleep quality and perceived social support positively affected breastfeeding self-efficacy of postpartum women. In addition, poor sleep quality poses a threat for negative mental health outcomes for women in the postpartum period. Previous studies reflect mothers' desire for non-pharmacological interventions and a high degree of satisfaction with these therapies. Laughter therapy, one of the main non-pharmacological interventions, is recognised as a universal approach to reduce stress and anxiety. The postnatal period is a fragile period with physical and psychological changes as well as hormonal changes in the mother. Poor mental health of the mother poses a danger to the well-being of the mother and the baby. Mothers in the postpartum period need low-cost, easily accessible preventive interventions to prevent these problems. In this context, the aim of this study is to determine the effect of laughter therapy given to mothers in the postpartum period on perceived stress, sleep quality and breastfeeding self-efficacy level in mothers.

Drug Excretion in Breast Milk

This is a prospective, non-randomized, phase I study design evaluating the in vivo activities and expression of OCT1 and BCRP in mammary gland of lactating women at three time points postpartum.

Iron Absorption and Requirements in Pregnancy and Lactation

Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common. The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya. In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.