Clinical Research Directory

Hybrid Breastfeeding Education in Late Pregnancy: Effects on Antenatal Attachment and Breastfeeding

This randomized controlled study aims to examine the effect of individualized hybrid breastfeeding education provided during late pregnancy on antenatal attachment and breastfeeding behaviors among first-time mothers. Participants will be randomly assigned to either the intervention or control group. Women in the intervention group will receive individualized hybrid breastfeeding education beginning at the 36th week of pregnancy. The program includes a face-to-face individual breastfeeding education session at 36 weeks of pregnancy and a reinforcement and practice session at 38 weeks. Participants will also have access to personalized digital educational materials, short educational videos, and online consultation support. In the postpartum period, participants will receive an online support session during the first week after birth and a follow-up session through online communication or telephone at the sixth postpartum week. The control group will receive routine hospital education during pregnancy. After completion of the study, the same educational materials will be provided to the control group in accordance with ethical principles. Data will be collected using the Demographic Information Form, Breastfeeding Behavior Evaluation Form, Antenatal Attachment Inventory, and Breastfeeding Self-Efficacy Scale. Written informed consent will be obtained from all participants prior to enrollment.

Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana

The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding. The main question\[s\] it aims to answer are: * Will CAB-LA injections work well as a way to prevent HIV infection in post-partum people? * Will CAB-LA injections be safe in post-partum people and their infants who will be breastfeeding? Participants without HIV who are admitted to the maternity ward after having delivered a baby will be offered to start CAB-LA PrEP. Those who choose to participate will receive their first dose (injection) at the maternity ward and their follow up doses (injections) at their local clinic when they come for routine post-partum and pediatric care. Participants and their infants will be followed in the study for 24 months. We will be following how many people come on-time for their CAB-LA injections, how often they keep coming back, and the reasons they continue (or stop) these injections. We will also test people for HIV at all of their visits to see how many people get HIV during the study. We will also measure the levels of the medication in the blood of the post-partum people and their infants (who may be getting some of the CAB-LA in breastmilk) and evaluate to see if their is any impact of CAB-LA on the health of the post-partum person or their infants.

Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring

Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.

Cannabidiol Into Breastmilk

Really few data published to date on the passage of CBD into breast milk. The investigators known that 17.5 percent of the French human being between 18 and 34 years old consume CBD and among this, nearly half are women. None official French data to say how many French breastfeeding mothers consume CBD. CBD is a legal, psychoactive but not psychoaddictive substance. CBD's pharmacokinetic and pharmacodynamics make us fear that CBD could easily go through mother's milk. No published data available on possible effect in breast-fed child, not even on possible biological passage in breast-fed child. The aim of his study is to evaluate the passage of CBD in blood and milk at different moments of the breastfeeding (mothers) and its possible found in the infants'urine.

Effect of Teach-Back Education on Breastfeeding and Bonding in Mothers of Preterm Infants

The aim of this randomized controlled experimental study is to contribute to the standardization of nursing interventions for premature mothers and to establish a scientific basis for breastfeeding education models in our country. It also aims to evaluate the effects of the following: digital privacy literacy, children's autonomy, decision-making ability, and privacy awareness. The hypotheses of the study are as follows: H₁: Mothers who received Teach-Back training have a higher level of breastfeeding self-efficacy. H₂: Mothers who received Teach-Back training have a higher level of mother-infant bonding. H₀: There is no significant difference between the groups.

Lingual Frenulum in Newborn Infants (LINNE)

Oral cavity's structural variations are involved in the successful breastfeeding of the newborn infants. The tongue-tie has been shown to cause breastfeeding problems. This project investigates the oral structural properties of the newborn infants and the efficacy and safety of their treatment options in breastfeeding problems. The project includes two studies: 1. A prospective follow-up study that investigates the epidemiology and associations between oral structures and breastfeeding problems in term and preterm infants; 2. A randomised, controlled study that investigates the efficacy and safety of tongue-tie treatments. Follow-up visits are planned two to three months, one year, and five years after randomisation along with a 6 months' e-questionnaire for all study patients. The study provides information at the population level.

Mobile Prenatal Education for Expectant Fathers and Its Effects on Bonding, Stress, Breastfeeding and Marital Satisfaction

The aim of this interventional clinical trial is to assess whether a mobile-based antenatal education programme for expectant fathers has a positive effect on father-infant bonding, stress levels, and breastfeeding attitudes. The study aims to answer the following main questions: Does participation in a mobile-based prenatal education programme strengthen fathers' emotional bonds with their babies? Does the education reduce fathers' stress levels during the prenatal and postnatal periods? Does it increase the father's knowledge and supportive attitude towards breastfeeding? Researchers will compare whether there are measurable differences in attachment, stress, and breastfeeding attitudes between the intervention group (fathers receiving mobile-based education) and the control group (fathers receiving standard routine information). Participants: Will complete pre- and post-intervention questionnaires assessing attachment, stress, and breastfeeding attitudes. The intervention group will have access to a six-module mobile application covering topics such as infant care, nutrition, sleep routines, health and safety, emotional development, and daily care practices. The study will be conducted with fathers aged 19-65 who became fathers within the last month and voluntarily agreed to participate.

Effect of Hypnobreastfeeding Education in High-Risk Pregnant Women

It is thought that hypnobreastfeeding training given to high-risk pregnant women will reduce anxiety levels, increase lactation, encourage breastfeeding, reduce the perception of insufficient milk, and facilitate adaptation to the postpartum breastfeeding process. According to the results of the power analysis, at least 68 high-risk pregnant women, 34 experimental and 34 control, should be included in the study. Data will be collected with the "Pregnancy Information Form", "Anxiety Assessment Scale", " Infant Feeding Intention Instrument", "Postpartum Information Form", "Perception of Insufficient Milk Questionnaire" and "Breastfeeding Adaptation Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the high-risk pregnant women in the experimental group.

At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)

The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology. This study addresses 4 crucial public health gaps: 1) how breast milk changes over time and over the day, 2) how milk dynamics are related to infant sleep patterns, 3) how milk dynamics are related to infant microbiome dynamics, and 4) how all these relationships differ between infants fed directly at-the-breast vs pumped milk. These fundamental insights have been unknown until now, so that families who feed pumped breast milk are completely underserved. These results are critical to optimizing infant feeding and health outcomes for all infants receiving breast milk.

Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination

The purpose of this study is to explore whether combining the first post-hospital newborn provider visit and lactation consultation into a single appointment can enhance rates of successful breastfeeding initiation and continuation at predefined intervals (e.g., one week, one month, two months, three months, four months, six months, and 12 months postpartum).

Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides

Primary Objective: * To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age. * To evaluate the effects of synbiotics on infectious morbidity and growth from 4 to 48 weeks of age. Secondary Objectives: * To evaluate the effects of synbiotics on growth from 4 to 72 weeks of age. * To evaluate the effects of synbiotics on infant neurodevelopment at 48 and 72 weeks of age. * To evaluate the effects of synbiotics on biological measurements while it is in place from 4 to 24 weeks of age. * To evaluate the effects of synbiotics on biological measurements from 4 to 48 weeks of age. * To evaluate the effects of synbiotics on gut microbiome and fecal short chain fatty acids from 4 to 72 weeks of age. * To investigate feasibility, acceptance, tolerability, and behavioral adherence with the intervention. * To investigate whether the synbiotics reduces infectious morbidity and improves growth in CHEU relative to CHUU. * To investigate whether infant gut microbiota composition, maturity and function, and markers of inflammation and HMOs at baseline and over time are associated with morbidity and poor growth in CHEU and CHUU.

Trauma-informed Obstetric Care for Perinatal Health: a Pilot Study

The study will test trauma-informed obstetric care training and supervision for obstetric clinicians in relation to prenatal mental health and attachment formation (early predictors of child development) in women presenting for prenatal care in a public hospital in Buenos Aires, Argentina.

Positive Feeding of the Preterm Infant

The goal of this feasibility study is to assess the feasibility to implement a feeding strategy for preterm infants. The main questions it aims to answer are: * Is it feasible to implement the PoP-intervention in a level 3a category Neonatal intensive care unit? * Is the PoP-intervention acceptable for parents of preterm infants and health care personnel working in Neonatal intensive care unit? Parents of preterm infants and health care personnel will be asked to follow a protocol of a feeding strategy based on the preterm infants development and cues throughout the NICU-stay.

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.

Developmental Impacts of Microplastics Exposure in Early Life

The goal of this observational study is to characterize and evaluate micro- and nano-plastic (MNP) exposures among mothers and infants in mother-infant dyads 1 or 3 months postpartum living in Baltimore, Maryland. The main questions it aims to answer are: * What MNPs are present in breastmilk and maternal blood samples and in their infants stool sample? * Are there associations between amount of maternal MNPs in breast milk and mass of MNP particles in infant stool? * Which environmental and lifestyle factors are most predictive of maternal MNP burden? * Is infant exposure to MNPs associated with birth weight and postnatal growth trajectories? Participants will: * Complete several questionnaires assessing medical histories, lifestyle factors, environmental exposures, eating behaviors, etc. * Provide biological specimens including: maternal blood, stool, and breastmilk; infant stool * Clinical visit to have anthropometric measures documented including maternal height and weight, infant weight, length, and skin-fold thickness

Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial

The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged research methods.

Breastfeeding Education Support Tool

The proposed project seeks to evaluate the effectiveness and implementation of the Breastfeeding Education Support Tool for Baby (BEST4Baby) intervention, an mHealth-supported community-based peer counselor breastfeeding intervention for mothers in India. Given that rates of optimal infant feeding practices have remained stagnant over the past two decades in India, and that India is the most populous country and icontributes one-fifth of all global live births, this project could have major global health implications if the intervention is found to improve maternal breastfeeding practices and infant clinical outcomes. The project will also provide evidence needed to adopt BEST4Baby nationally and in other low resource communities.

UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk

The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake. The main questions it aims to answer are: * What is the concentration of maternal medicines in human milk? * What is the (estimated) intake and exposure in the breastfed infant? Participants will be asked to * fill out a questionnaire regarding medical data of the mother and child * track medication intake for 3 days * collect milk samples during 24 hours * optionally, donate 2 blood samples of the mother and give consent to one blood sample of the child * fill out a questionnaire regarding the general health of the child.

Evaluation of the Effectiveness of a Breastfeeding Education Program Based on Planned Behavior Theory

The aim of the research is to examine the effect of a breastfeeding training program based on the theory of planned behavior on Pregnant Womens' Breastfeeding Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning.

Microbiome and Malnutrition in Pregnancy

This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on pregnant women, 28 years and younger living in the Toronto and greater Toronto area. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. With the hypothesis that alterations of the microbiota in the maternal gut (dysbiosis) exacerbated by nutritional status or pathogen exposure during pregnancy, impacts weight gain because of impaired nutrient absorption, leading to corresponding negative birth outcomes.

Integrated Sensory Supported Virtual Reality and Gamified Digital Breastfeeding Education

Breastfeeding is the most ideal form of nutrition that concerns the health of mother and baby. The World Health Organization (WHO) recommends that breastfeeding should be started within the first hour after birth. Although breastfeeding has many benefits, research shows that breastfeeding rates are not at the desired level. Breastfeeding self-efficacy, success and adaptation become important to increase breastfeeding rates. In order to provide these components related to breastfeeding, breastfeeding education must be given starting from prenatal period. Education methods have taken different forms in line with the developing technology and the needs of the generation. WHO states that information and communication technology is an opportunity to support breastfeeding. Virtual reality and online learning applications also positively affect learning. New teaching methods, which are increasingly used today, make learning easier and can be used easily in virtual environments. Providing learning by doing in a realistic environment is important for successful breastfeeding and gaining breastfeeding skills and competence. In order to gain breastfeeding skills, the mother can experience breastfeeding during pregnancy using virtual reality technology. While breastfeeding skills are gained through virtual reality, information about breastfeeding can be provided through gamified digital training. With the game, the student actively participates in education. Active participation of the student in gamification ensures that knowledge becomes permanent. It is thought that the effect of the integrative sense can be used to facilitate postpartum remembering of these trainings.

The Effect of Musıc on Labor Paın, Anxıety and Breastfeedıng Success

The aim of this study is to examine the effects of music played to primiparous women who had a cesarean section on pain, state anxiety and breastfeeding success.

The Effect of Breastfeeding Counselling with Motivational Inter-viewing Technique on Breastfeeding Problems and Anxiety

The primary aim of this study was to investigate the effect of motivational interviewing technique on breastfeeding problems and loss. H1:The breastfeeding problems score of the mothers who received motivational interviewing was lower than the mothers who received standard care. H 2: The anxiety level score of mothers who received motivational interviewing is lower than that of mothers who received standard care. H3: The rate of exclusive breastfeeding of mothers who received motivational interviewing is higher than that of mothers who received standard care.

The Effect of Oketani Breast Massage on Breastfeeding

This study aims to determine the effects of Oketani breast massage on breastfeeding success, breastfeeding self-efficacy and satisfaction of primiparous mothers.