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

Empowering First-Time Mothers

This randomized controlled trial aims to evaluate the effect of digital lactation nursing support on breastfeeding achievement and maternal-infant outcomes among first-time mothers.

Breastfeeding Evaluation of Puerperal Women Who Had Cesarean Delivery in Our Hospital

İntroduction The World Health Organisation (WHO) and United Nations Children's Fund (UNICEF) recommends that infants are exclusively breastfed for a minimum of 6 months, with continued breastfeeding recommended until child age of 2 years or over to optimize growth, development, and health. Breast milk shows significant benefits for the physical and mental health of mothers and infants, including the promotion of maternal and infant bonding, the reduction of neonatal mortality, the reduction of maternal postoperative complications, and the development of newborns. Breastfeeding has been associated with improved maternal/infant bonding and increased child intelligence. It is also clear that medical interventions during labor and birth, including a caesarean section, impact on women's infant feeding decisions and are a cause for concern given increasing global caesarean birth rates, with woman who have a planned caesarean birth reported as less likely to intend to breastfeed than women who did not have a planned caesarean birth or had a vaginal birth. Infrequent feeding and women's limited mobility in the early days following surgery may impede efforts to provide basic infant care. High levels of postoperative pain, particularly in the first 24 hrs, were also found to have a negative impact on women's breastfeeding experiences. Cesarean delivery is linked with lower rates of early breastfeeding initiation. Pain management after casarean delivery remains challenging. The best-accepted traditional analgesic approach is continuous epidural analgesia. However, epidural analgesia is rapidly being replaced by transversus abdominis plane (TAP) blocks. TAP infiltration is an alternative to epidural blocks for providing postoperative analgesia to the anterior abdominal wall. TAP infiltrations are relatively easy to perform, generally safe, and can be performed in patients who are anti-coagulated. TAP infiltration can be performed as a single injection, or a catheter can be inserted for continuous local anesthetic infusion.

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.

TENS for Postpartum Uterine Pain During Breastfeeding

This clinical study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is an effective, non-drug method to relieve postpartum uterine pain during breastfeeding in multiparous women (women who have given birth multiple times). Breastfeeding in the first 48 hours after delivery often triggers strong, painful uterine contractions due to the natural release of oxytocin. While standard care typically relies on pain-relief medications, this study investigates if TENS, a safe, low-cost device that sends gentle electrical impulses through small skin patches, can significantly reduce this pain and decrease the need for systemic medications. Participants will be randomly assigned to either receive standard postpartum pain medications or use a TENS device during two consecutive breastfeeding sessions. Researchers will measure and compare the peak pain levels between both groups using a standard 0 to 10 pain scale. The aim is examining whether TENS will significantly reduce postpartum uterine pain during breastfeeding and decrease medication use compared with standard care.

Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC

This prospective observational study aims to evaluate fecal calprotectin levels as an early indicator of necrotizing enterocolitis in preterm infants and to compare levels between breastfed and formula-fed preterm infants at Assiut University Children Hospital.

Reducing Turkey High Cesarean Section Rates

Considering the increasing rates of cesarean delivery in Turkey, we aimed to research the impact of antenatal education on pregnancy, the childbirth process, the cesarean section rate, and the postpartum period through a randomized controlled study. METHOD: A total of 120 pregnant women (40 in the education group and 80 in the control group) with a gestational age of 28 weeks or more were included in the study from the Üsküdar. The education group trained face to face in the Childbirth Preparation Class. Only if, pre- and post-training tests were administered to the education group to evaluate sociodemographic characteristics, educational needs, birth preferences, satisfaction with the training, and the behavioral outcomes gained from the training.

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.

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.

Virtual Reality (VR)and Mobile-Based Smoking Cessation in Breastfeeding Mothers

This randomized controlled trial was conducted to evaluate the effect of an educational video delivered through virtual reality (VR) glasses and a mobile application on smoking cessation behavior among breastfeeding mothers. The study was carried out in the breastfeeding outpatient clinic of a secondary-level public hospital. A total of 76 breastfeeding mothers with infants aged 0-6 months who reported active cigarette smoking were enrolled. Participants were randomly assigned to either an intervention group (n = 35) or a control group (n = 41) using a simple randomization method. Mothers in the intervention group viewed an educational video through VR glasses and a mobile application that provided evidence-based information on the harmful effects of smoking on maternal and infant health and encouraged smoking cessation. The control group received routine breastfeeding care and counseling provided by the clinic. Participants were followed for six months, with assessments performed at baseline and at the 1st, 2nd, 4th, and 6th months after the intervention. Data were collected using the Personal Information Form, the Fagerström Test for Nicotine Dependence, and the Questionnaire of Smoking Urges-Brief. The primary objective was to evaluate changes in nicotine dependence and smoking urges over the follow-up period and to determine the effectiveness of the VR- and mobile application-based educational intervention in supporting smoking cessation among breastfeeding mothers.

Midwife-Led Home-Based Postpartum Follow-up Program

This randomized controlled trial evaluated whether a structured, midwife-led home-based postpartum follow-up program could improve breastfeeding self-efficacy, postpartum sleep quality, and maternal attachment among postpartum women. A total of 98 women were randomly assigned in a 1:1 ratio to either the intervention group or the control group. In addition to routine postpartum care, women in the intervention group received an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week. Women in the control group received routine postpartum care. Breastfeeding self-efficacy, postpartum sleep quality, and maternal attachment were assessed at baseline and at six weeks postpartum.

AI-Based Oxytocin-Stimulated Smart Lactation Support Vest

AI-Based Oxytocin-Stimulated Smart Lactation Support Vest: Development of a Thermo-Massage and Vibration Wearable Vest Design to Support Milk Flow and Prevent Milk Duct Obstruction During Lactation

Scapular Stabilization Exercises Combined With Thoracic Mobilization in Breast Feeding Mothers With Upper Back Pain

Upper-back pain is common among breastfeeding mothers and may be associated with prolonged feeding positions, forward-bent posture, reduced thoracic mobility, and weakness of the muscles controlling the shoulder blades. This study will compare scapular stabilization exercises combined with thoracic spine mobilization with scapular stabilization exercises alone in breastfeeding mothers experiencing upper-back pain. Seventy eligible breastfeeding mothers aged 18-35 years will be assigned to one of two treatment groups. Both groups will receive scapular stabilization exercises, while one group will additionally receive thoracic mobilization performed by a trained physiotherapist. Treatment will be provided three times per week for eight weeks. Pain intensity, functional ability, and spinal range of motion will be assessed at baseline, Week 4, and Week 8. The study aims to determine whether adding thoracic mobilization to scapular stabilization exercises provides greater improvement in pain, mobility, and daily functioning than scapular stabilization exercises alone.

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.

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.

The Effects of Sustainable Lactation Support and Partner Endorphin Massage

Research Design This study is designed as a randomized controlled experimental study in which participants are blinded. Location and Characteristics of the Study This research will be conducted in the Obstetrics and Gynecology Department of the State Hospital. State Hospital has been a baby-friendly hospital since 1995. Baby-friendly hospitals are hospitals that encourage breastfeeding, provide mothers with information and correct habits about breastfeeding, and continuously support mothers in initiating and maintaining breastfeeding.In baby-friendly hospitals, breastfeeding consultants trained with up-to-date information provide support to mothers during working hours (08:00-16:00), during pregnancy and the postpartum period, until they are discharged or whenever they visit the outpatient clinic, on topics such as breastfeeding, breast milk, and breastfeeding positions. Midwives and nurses working in the obstetrics and gynecology department provide breastfeeding counseling to mothers during on-call duties and weekends, as well as supporting mothers during working hours. Related/Independent Variable of the Study In this research; Independent variables: socio-demographic characteristics, partner endorphin massage, midwife breastfeeding support Dependent variables: mood, breastfeeding self-efficacy, and maternal bonding Study Population and Sample The study population consists of women who had normal vaginal deliveries at a state hospital between the specified dates.The sample size was determined as 52 women, based on the mean self-efficacy score calculated using breastfeeding self-efficacy data from the study by Yenal et al., with an effect size of 0.8 at a 95% confidence interval and a representativeness of 0.80. 26 women will be included in the control group and 26 in the experimental group.However, considering data loss, the number was calculated as 30 for the control group and 30 for the experimental group.

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.

Investigation of the Effect of Video-Assisted Breastfeeding Education on State Anxiety, Breastfeeding Myths, and Breastfeeding Motivation in Primiparous Mothers

This randomized controlled trial aims to evaluate the effectiveness of a video-assisted breastfeeding education program for primiparous pregnant women. The intervention is designed to improve breastfeeding motivation, reduce breastfeeding myths, and decrease state anxiety related to breastfeeding. Pregnant women receiving antenatal care at Family Health Centers in Iğdır Province will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive structured video-based breastfeeding education in addition to routine care, while the control group will receive routine antenatal and postnatal breastfeeding education only. The findings of this study are expected to provide evidence regarding the effectiveness of technology-supported breastfeeding education in promoting positive breastfeeding-related outcomes among first-time mothers.

RELIANCE: Moringa in Lactation and Early Childhood

This study will assess the impact of maternal moringa supplementation to mothers of breastfeeding infants on milk output, milk composition, exclusive breastfeeding duration, and maternal and child health. This will be accomplish by conducting a randomized, controlled dietary intervention study enrolling breastfeeding mothers and their newborn infants. Mothers will be randomized to receive either 10g dried moringa leaf powder in carrier vs. carrier alone, consumed daily for four months, with follow-up for 2 years. Women must be \>18 years of age, ≤ 21 days postpartum and currently lactating at the time of enrollment. Infants must be at least 37 weeks of gestational age, be healthy and are able to feed orally and consume human milk. After randomization and enrollment, breast milk samples will be obtained at baseline, 2, 4, 6, 9 and 12 months. Serum from mothers will be collected at recruitment, 2, 4, 6,and 12 months; infant serum will be collected by capillary sample at recruitment and approximately at 2, 6, 12, and 24 months. Infant feeding weights (test weights) will be collected on sequential days at recruitment, 4, and 6 months. Dietary recall: the foods and drinks consumed by mothers in the past month prior to each milk sample. Other assessments will include perceptions of breastfeeding, assess complementary feeding practices. Review will be conducted of maternal and infant infections, diagnoses, and hospitalizations at the time of visit or since the last visit.

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.

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).

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

eHealth for Breastfeeding Support - the HOTSPOT Trial

This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a "pilot" study because the app is still in development. The goal of this research is to see if mothers use the app more when they receive text "nudges" to look at it compared to not getting those "nudges". The research project is being conducted by Lydia Furman MD. The purpose of the app (which is currently in clickable "wireframe" status, a "pre" app phase) is to support and promote breastfeeding specifically for mothers and fathers/partners who are African American or Black. Other breastfeeding apps have pictures mainly of White or Asian mothers and information that is not oriented toward African American mothers. This app aims to provide accurate and needed breastfeeding information that is culturally attuned. Up to 24 participants will be enrolled at UHCMC, including up to 20 mothers. Other participants will include up to 4 African American or Black fathers/partners whose partners are interested in breastfeeding.

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.