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NCT07561099
The goal of this clinical trial is to evaluate whether auricular acupressure combined with basic care can improve symptoms in postpartum women with blocked milk ducts after cesarean delivery. The main questions it aims to answer are: * Does auricular acupressure combined with basic care reduce breast pain more effectively than basic care alone? * Does the combined approach improve the severity of milk duct blockage compared with basic care alone? * What adverse effects may occur in participants receiving auricular acupressure? Researchers will compare auricular acupressure combined with basic care to sham auricular acupressure plus basic care to determine whether the intervention provides additional benefits. Participants will: * Receive auricular acupressure (or sham auricular acupressure at non-therapeutic ear points) for 3 days. * Be instructed to perform basic breast care under the supervision of midwives three times daily for 3 days. * Record daily activities in monitoring forms, including breastfeeding times, and whether they performed warm compresses and breast massage.
NCT07481643
In pregnant women, non-pharmacological methods such as music, massage, yoga, meditation, relaxation breathing exercises, and acupuncture have been tried to reduce anxiety during childbirth, and there are studies on these in the literature. However, researchers have not come across a study in the literature that evaluates the effect of positive affirmations on perioperative maternal anxiety and breastfeeding together. Researchers aim is to evaluate the relationship between anxiety, sedation, and breastfeeding levels in pregnant women who underwent positive affirmations and music therapy during cesarean section.
NCT06548828
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.
NCT06558071
This is a randomized, double-blind, and placebo-controlled study involving mothers as the participant and participant's babies evaluating the effect of a 15-day-supplementation with a product containing extracts derived from a combination of herbal plants (katuk \& torbangun leaves) and snakehead fish in stimulating breast milk production.
NCT07351799
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.
NCT07336186
This study evaluates whether using virtual reality (VR) for relaxation helps mothers of premature babies produce more breast milk and feel more confident about breastfeeding. Mothers in the intervention group used VR headsets to watch calming nature videos while listening to music before expressing milk. The study compares their milk volume and self-efficacy scores to a control group receiving standard care.
NCT06909123
Most patients seeking abortion care or management of pregnancy loss in the second trimester will lactate, which can be physically and emotionally painful. The efficacy of a one-time dose of cabergoline has been previously demonstrated to prevent breast symptoms for these patients. This study seeks to determine if investigators can more precisely manage these patients with a reduced dose appropriate for the physiology of the second trimester, thereby reducing the medication cost and reducing or eliminating the uncomfortable medication side effects.
NCT06029673
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.
NCT07036640
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.
NCT06811298
This randomized controlled study aims to examine the effects of breast massage and virtual reality applications on breastfeeding in women after cesarean delivery. The study will include mothers aged 18-45, who have delivered a healthy baby via cesarean section at an Obstetrics and Gynecology Department of a University Training and Research Hospital located in the Aegean Region. Participants will have no health issues preventing breastfeeding, will have previously received breastfeeding counseling, and will be included after providing informed consent following the explanation of the study's objectives. The primary research questions addressed in this study are as follows: Does breast massage applied to women after cesarean delivery affect breastfeeding? Does the application of virtual reality to women after cesarean delivery affect breastfeeding? The research groups will be randomly assigned into three groups-virtual reality, breast massage, and control-before any interventions are applied. Randomization will be performed using the website www.randomizer.org to determine the group allocation for each participant. In this study, 31 mothers in the virtual reality group will be shown a 15-minute virtual reality video, depicting a river and forest, viewed through a virtual reality headset, in order to create a relaxing and calming environment. This will be done on post-operative day 0, at the 3rd hour, and at the 24th hour. In the breast massage group, 32 mothers will receive breast massage for 15 minutes, administered by the researchers at the same time points (post-operative day 0, 3rd hour, and 24th hour). After the interventions, mothers will be asked to breastfeed their babies, and the babies will be weighed both before and after breastfeeding. The control group will receive no intervention and will receive standard care (31 women). Infant weight measurements will also be taken at the same times in the control group. After the interventions, the LATCH Breastfeeding Charting System and Documentation Tool, along with the Breastfeeding Self-Efficacy Scale, will be applied to all groups on post-operative day 0, at the 3rd hour, and at the 24th hour. A descriptive information form will be used to determine the sociodemographic and obstetric features of the participants in the study.
NCT06563726
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
NCT03668977
This project will test the efficacy of a balanced protein energy supplement for daily use during pregnancy and the first 6 months after delivery on the outcomes of pregnancy and growth of infants during the first 6 months of life. Approximately 1800 pregnant women from a district in southern Nepal will be recruited and randomly assigned to one of 4 groups, control in pregnancy \& post-partum, supplementation in pregnancy \& control post-partum, control in pregnancy \& supplementation post-partum, or supplementation in pregnancy \& post-partum. Pregnancies will be followed until delivery and the infants through 6 months of age. Outcomes of interest include birth size (weight and length), gestational age at delivery, maternal weight gain in pregnancy, maternal weight at 6 months post-partum, infant growth, and breast milk composition.
NCT04024865
The purpose of this study is to determine whether the use of domperidone is associated with an increased risk of serious cardiac events among postpartum women in the six months following delivery. The hypothesis is that the use of domperidone will be associated with an increased risk of serious cardiac events among postpartum women. The investigators will carry out separate population-based cohort studies using health care databases in five Canadian provinces. Women with live births will be eligible to enter the cohort. We will identify all women who start domperidone during the six months following delivery and match them to similar women who do not start domperidone, with all included women followed until the occurrence of an adverse cardiac event or for up to six months after delivery. The results from the separate sites will be combined to provide an overall assessment of the risk of serious cardiac events in users of domperidone.
NCT06123026
The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. The participants will be randomly placed in two groups, one with a placebo tablet and one with medication called "cabergoline" which are taken immediately after their procedure. Researchers will compare groups to see if there are any significant differences in breast symptoms.
NCT06264349
The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies. Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood.
NCT05973552
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.
NCT05211076
This study was planned as a randomized controlled study to examine the effect of music practice and Marmet Technique on lactation and maternal anxiety in mothers with premature babies in the neonatal intensive care unit.The research will be carried out with 32+0 and 36+6 weeks old preterms hospitalized in the Suleyman Yalçin City Hospital NICU.It will be held between January and December 2022 with mothers of premature babies born by cesarean section between weeks of gestation.The research will be carried out with three groups as music,Marmet Technique and control group.The sample number was calculated using the G\*Power program and the music group:22,the Marmet Technique:22,and the control group: 22 (n=66).It is planned to collect the data with the Introductory Information Form, the Breast Milk Follow-up Form, the State Anxiety Scale and the Maternal Satisfaction Evaluation Scale.Post-op with mothers on day 8-12. Information about the research will be given by meeting between hours and written and verbal consent will be taken.Randomization will be applied to the mothers who accepted the study.During the study,all mothers will be informed that music and Marmet Technique will be performed at 11:00 and 17:00, 2 sessions a day for 4 days,starting from the post-op day 1,and then the milking process will be performed,and the mothers will be provided to come to the breastfeeding room at the specified times.The State Anxiety Scale will be filled in by the mother,and then the music will be played for 15 minutes.In the 16th minute,milking will be performed manually by the researcher and the milking process will take at least 15 minutes.After the milking process,the mother will fill the State Anxiety Scale again.In the Marmet Technique group,the State Anxiety Scale will be filled first by the mother,and then massage and milking will be performed for 20-30 minutes in accordance with the protocol of the technique.After the milking process,the mother will fill in the State Anxiety Scale again.No application will be made to the control group. Breast milk will be provided manually by the researcher for at least 15 minutes.The data of the research will be evaluated using the SPSS program.In the evaluation of the data;descriptive statistics will be done with One Way Analysis of Variance Kruskal Wallis H Test.In order to determine the difference in milk amounts between groups,repeated measure covariance analysis will be applied.
NCT05123183
Primiparous mothers after cesarean section often encounter insufficient milk production during breastfeeding. This study was planned as a randomized controlled study to examine the effect of acupressure and back massage on lactation in cesarean deliveries. The research will be carried out between July 2021 and July 2023 with mothers who had a cesarean section at Kocaeli University Research and Application Hospital and Health Sciences University Derince Training and Research Hospital. The research will be carried out with three groups as acupressure, back massage and control group. The sample number was calculated using the G\*Power 3.1.9.2 program and the acupressure group: 24, the back massage group: 24, and the control group: 24. In order to increase the analysis power, the number of samples was increased by 25% and n=30 for each group (acupressure group: 30, back massage group: 30, and control group: 30). It is planned to collect the data with the Introductory Information Form, the Newborn Follow-up Form, the Mother's Follow-up Form, and the Visual Analogue Scale by which the Mothers Evaluate Lactation Onset Symptoms. The mothers will be given acupressure 4 minutes acupressure group, back massage group 3 minutes back massage, and no application will be made to the control group, once in the post-op 0th day, 2 times in the post-op 1st day and once in the post-op 2nd day. 15 minutes after the applications, the baby will be weighed while hungry and will be breastfed under the control of the researcher. Babies will be weighed again after breastfeeding. The data of the research will be evaluated using the Statistical Package for the Social Sciences 20.0 program. In the evaluation of the data; descriptive statistics will be given as percentage, arithmetic mean±standard deviation, median and minimum-maximum values, independent two-sample t-test for normally distributed variables and Mann-Whitney U test for non-normally distributed variables. Repeated measure covariance analysis will be applied to reveal the difference between the milk amounts of the mothers between the groups. Statistical significance level will be accepted as p\<0.05.
NCT05207241
Lactation is the instinct of almost all mammals, including human beings. With the development of human society, the function of lactation has gradually deviated from nature instinct. Breastfeeding related industries, such as milk bottles, formula and breast pumps, have formed a vast consumer market, leading to a transition from breastfeeding mothers' individual instinct to the social division of labor. Previous studies found that the incidence of lactational mastitis remains largely unchanged post World War II with some reporting an increase, suggesting the hazards of lactational mastitis still exist under the background of social division of labor. Breast milk contains ingredients that improve the immunity of newborns. By affecting mothers' breastfeeding, lactational mastitis pose a hazard for newborns, increasing the chances of developing respiratory and gastrointestinal diseases. For breastfeeding mothers, severe mastitis may develop into breast abscess due to improper treatment in the early stage. In addition to antibiotic treatment, incision, drainage and even surgery may be required. These potentially increase the risk of developing postpartum depression, type II diabetes, breast cancer and ovarian cancer. Compared with other mammals, humans and cows have a higher incidence of lactational mastitis, indicating that human intervention in breastfeeding may be the cause of the high incidence. On the other hand, as a result of walking upright, humans' hands are liberated, forming complex and diverse breastfeeding position. According to the Sakra World Hospital, these positions are classified into eight types: cradle, cross cradle, supine, football, Australian hold, inverted lateral, lateral cradle, and lateral. The pilot study demonstrated that different breastfeeding positions are closed related to the occurrence of lactational mastitis, and to the location of mastitis. Assuming that the baby's sucking factors remain the same, there must be differences in the milk drainage in different breastfeeding positions under the influence of gravity. Researchist speculate that breastfeeding women who opt to a position that cause an anti-gravitational expulsion of milk are more likely to develop lactational mastitis. Therefore, this study aims to investigate how the scientific guidance on the gravitationally assisted breastfeeding positions will reduce the occurrence of mastitis.
NCT04593719
Background: While caesarean sections are increasing, breast-feeding rates are decreasing. It is important to implement supportive programs to ensure mothers breast feed for the desired period and infants are fed by only mother's milk. Aim: In the research, it was aimed to evaluate the effects of lactation management models on mothers' breastfeeding process following a caesarean section. Methods: The research was conducted as a randomized controlled study and experimentally. Before implementation, Lactation Management Model was developed. Data collection was performed during gestation, first day after postpartum, pre-discharge, on 9th day in face to face interview and in the form of monthly phone interviews up to 6 months. While the experimental group exercised lactation management model, control group received routine lactation practices in clinic. Conclusions: Among the females in the experimental group, it was found that breastfeeding self-efficacy were higher, and breastfeeding techniques were accurate and successful and breastfeeding only and continuity rates were higher while breastfeeding related breast problems developed less frequently. Lactation management model should be used and expanded to increase breastfeeding rates. Keywords: Cesarean section, breastfeeding, mother milk, lactation management model, breastfeeding training