280 Clinical Trials for Various Conditions
This study is about preparing women with excessive weight to have better breastfeeding outcomes. By doing this study, we 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.
The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.
SALT is a multi-centre, non-blinded, non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. A drop in Na is a sign of secretory activation in the breast that is associated with adequate short and long-term breast milk volumes in this vulnerable population. Primary Objective: Establish feasibility, acceptance, and time cost of parent-led parent milk Na testing in the first 14 days postpartum Secondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomes Exploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes
The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.
The innovative platform MILC is designed to provide an integrated and comprehensive professional and social support network with personalized breastfeeding (BF) education to target exclusive breastfeeding (EBF) and any BF behaviors in low-income Hispanic women. Formative research conducted for the development of MILC and results from pilot testing will help guide the completion of the development and testing of this prototype that specifically caters to Hispanic women. In the long term, MILC has the potential to increase the rates of EBF and any BF up to 12 months.
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.
The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Bright By Text), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC.
The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application.
The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance. Study start date is either start of data collection or first patient enrolled whatever occurs earlier. The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this surveillance program.
Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Dopamine agonists have previously been shown to be effective in lactation inhibition for third-trimester fetal/neonatal loss or contraindications to breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28 weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.
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.
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.
To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy (primary outcome).
This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.
The percentage of women breastfeeding their newborn babies is very low among minority populations such as African American women in Mississippi. There are good results with initiatives supporting the initiation of breastfeeding after delivery. However, the percentages of continuation of breastfeeding up to 3, 6 or 12 months are still very low in Mississippi. Therefore, this project is proposing to focus on community interventions including social and cultural components to promote and support continuation of breastfeeding. * The social component will include interventions to promote supportive environments in the workplace for lactating mothers, as well as promoting the use of mother's milk to feed infants in daycare centers. * The cultural component will focus on educating and raising awareness of the benefit of BF to prevent absenteeism at work, to reduce child illnesses, and to promote healthy child development. The cultural component will target the mother with her family and spouse/partner, employers, and daycare managers.
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.
Nursing students (N=32) will be randomized to begin period 1 in either a high-fidelity or low-fidelity simulated experience with a mock patient wearing a breast model and holding a newborn simulator and then cross over in period 2 to the opposite arm. Data on student satisfaction, engagement, self-efficacy, and performance and simulator fidelity will be collected via Qualtrics surveys (defined, 6-point Likert scale), written and oral reflection, audio-video recordings of clinical lactation encounter, and clinical lactation skills checklists and global performance ratings. Nursing students in the accelerated master's program will be recruited while completing their required simulation coursework. A random number generator will be used to randomly assign students to a treatment arm. Investigators will require at least 8 students per arm (power 80%, alpha 5%). Investigators will recruit 32 students for two study dates to compare the high-fidelity LiquidGoldConcept products to two competitor products. The Johns Hopkins School of Nursing and Simulation Center will be the only sites where human subjects research will be performed. The collaborating investigators (Drs. Debbie Busch, Joanne Silbert-Flagg, and Nancy Sullivan) have expertise in clinical lactation education and simulation. With the collaborating investigators LiquidGoldConcept has already completed pilot studies to establish the feasibility of our approach and validate the survey instruments.
This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.
This study will assess the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills (POPs) on maternal, breastmilk, and infant outcomes.
This project will assess the impact of a novel breastfeeding support intervention ("telelactation"), delivered via video calls on personal devices including mobile phones and tablets. The goal of this intervention is to increase access to International Board Certified Lactation Consultants to improve, and reduce disparities in, breastfeeding rates. By implementing a digital randomized controlled trial that recruits participants through a popular pregnancy tracker mobile phone application, this mixed methods study will recruit a national sample of 1800-2400 individuals (depending on rate of attrition) during their third trimester of pregnancy to 1) provide evidence on the effectiveness of a widely available, yet understudied, service and 2) leverage technology to promote one of the most widely recommended health behaviors to improve children's health and to reduce disparities in key maternal and child health outcomes.
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects. During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory. Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby's life. They will also be asked to complete growth and development questionnaires about their baby.
To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy.
Lactation cookies contain ingredients thought to increase breast milk production. Although these cookies are widely purchased and consumed with the intention to increase breast milk supply, no scientific investigation has explored the effects of lactation cookies on human breast milk production. This study will evaluate the effects of a lactation cookie in breast milk production, relative to cookies without ingredients thought to increase breast milk production in exclusively breastfeeding mothers of healthy, term babies.
Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos. Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.
This research study investigates the use of a drug, cabergoline, given immediately after second-trimester abortion or perinatal loss to decrease breast engorgement. Cabergoline is a medication approved for the symptomatic treatment of pituitary adenomas that result in a hyperprolactinemic state (a brain tumor that results in milk leakage). The benefit of stopping milk leakage has also been studied and used in populations who shouldn't breastfeed. The investigators aim to clarify if cabergoline is effective in preventing breast engorgement and milk leakage after second-trimester abortions or perinatal loss (stillbirth). Breast engorgement causes physical pain and emotional distress as lactation is uniquely associated with parenthood and those undergoing second-trimester abortions are doing so because they choose not to parent or a previously desired pregnancy is now complicated by anomalies. As there are no current recommendations for management of this painful engorgement beyond icepacks and support bras, the investigators aim to validate the use of this pharmacologic option in this setting.
Given the known health benefits of breast milk, the World Health Organization and pediatric and obstetrical professional societies all recommend that babies only consume breast milk (also referred to as "exclusive breastfeeding (EBF)") through 6 months of age. While many women initiate breastfeeding while at the study institution hospital, the rate of exclusive breastfeeding when mothers and babies are discharged is only 34%. Sixty percent of mothers stopped breastfeeding earlier than intended to primarily due to concerns about difficulty with lactation (i.e. sore nipples, inadequate milk supply), baby's nutrition (i.e weight gain and satiety) and effort required to pump breast milk. It is known that prenatal education by trained health care providers is effective in increasing EBF rates; however, these interventions are time and labor intensive and require employment of breastfeeding specialists. Therefore, a simple, brief, easily accessible breastfeeding education tool is needed to directly educated new mothers on how to breastfeed and what the actual nutritional needs of an infant are in order to support women's breastfeeding goals. The objective of this study is to assess whether a simple breastfeeding education video viewed at the time of admission to the hospital for delivery will increase EBF at the time of hospital discharge through 6 months postpartum by improving women's perception of their milk supply and their breast feeding efficiency. The investigators predict that woman who view a short breastfeeding education video just prior to delivery will have an improved perception of their breastfeeding efficiency and milk supply and will be more likely to avoid formula use while admitted to the hospital and though 6 months postpartum. In this study, the investigators will randomly assign women to view an educational video focused on breastfeeding in the first days of a baby's life and compare them to women who receive the standard educational pamphlet on breastfeeding given to all women delivering at the study institution. The investigators will then survey each participant after her delivery on how she is feeding her baby (breast milk, formula, or both) and how she perceives her milk supply and breastfeeding efficiency just before she is discharged from the hospital. The investigators will then call women on the phone at 6 weeks, 3 months and 6 months to reassess how they are feeding their babies (breast milk, formula or both). In addition to baseline characteristics about the individuals such as age, race, and employment status, information regarding their pregnancy and delivery will be obtained to assess for any confounding factors that may effect their ability to breastfeed. This research will help determine if video education can provide sufficient education to help increase breastfeeding rates. Additionally, this research may inform the research community on the overall effectiveness of video education in healthcare, allowing for a similar approach to be used for other educational initiatives.
This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.
This project will establish that pediatric and family medicine residents who complete a hybrid breastfeeding medicine curriculum that includes an asynchronous unfolding case scenario along with telesimulation with a standardized patient (SP) will provide timely, skilled lactation support more frequently than residents randomized to an asynchronous unfolding case scenario followed by videoconference group discussion regarding care for the breastfeeding dyad.
Breast milk is universally recognized as the best food for newborns. Studies have scientifically shown that breastfeeding provides optimal nutrients for infants, strengthens their immune system, and improves mother-and-child bonding. Demonstrating health benefits of pomegranate consumption on infant health could lead to greater incentive for women to breast feed. The purpose of this research study is to determine whether pomegranate metabolites (products produced by breakdown) is secreted into breastmilk and whether they have an effect on breast-fed infants who are born vaginally.