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NCT06125860
The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.
NCT07309562
This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). Safety and efficacy will be comprehensively evaluated.
NCT06723392
This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \[End preventable deaths of newborns and children under 5 years of age\] by examining the potential impact of this practice to reduce the incidence of SVN/SB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).
NCT04367181
The researchers are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA) infants, such that in the future, real-time monitoring will be possible, to aid clinicians in management of these infants. The researchers wish to establish a new NIRS device, diffuse correlation spectroscopy (DCS), as a safe, noninvasive and informative bedside tool for assessing and monitoring brain health in ELGA infants during the first few days of life. It is hoped that this method will provide detailed information on changes in oxygen consumption and metabolism, and cerebral perfusion. This technique will have wide applicability, but for this research study, the researchers wish to focus on the effect of blood flow instabilities, intermittent hypotension and hypoxic episodes, pressure passive CBF periods, and hypoperfusion on the preterm brain during the first days of life, and the relationship with incidence of intraventricular hemorrhage (IVH). The researchers aim to recruit 100 premature infants to obtain data to: 1. Test the feasibility of NIRS-DCS to monitor cerebral activity, perfusion and oxygen consumption in extremely premature infants during the first week of life. 2. To assess if these baseline values are impacted by intermittent hypoxic episodes. 3. To assess if cerebral blood flow disturbances correlate with incidence of intraventricular hemorrhage. 4. Correlate the NIRS-DCS findings with clinical outcome at hospital discharge.
NCT06315127
The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units. It aims to explore whether supplementation with donor milk vs formula for infants during the initial hospital stay in a well-baby unit will increase both the exclusivity and duration of breastfeeding at 4 months. The Investigators will also explore whether the type of supplementation will positively affect measures of newborns' health, growth, behavior, feeding efficacy, and parental stress. Each participating infant born to a diabetic mother OR born small for his/her gestational age (\<2500 grams) OR late preterm (35 0/7-36 6/7 weeks of gestational age) is assigned at random to 2 groups. The groups are: 1) Donor milk: all babies in this group will receive pasteurized donor milk from a trusted milk bank. 2) Formula: all babies in this group will receive formula as a standard of care.
NCT06957769
The goal of this study is to learn how being exposed to high environmental temperatures during pregnancy affects the health of pregnant women and their babies. The study also aims to understand how the body responds to heat stress during pregnancy and how this might lead to pregnancy complications and birth problems like early birth or low birth weight. The main questions that the study aims to answer are: 1. What are the acute and chronic effects of environmental heat exposure on pregnancy and birth outcomes across different trimesters? 2. Through which biological pathways does heat stress impact maternal, fetal, and infant health across varying gestational ages? 3. How do socio-demographic factors, maternal characteristics, and nutritional status of women modify the relationship between environmental heat exposure and adverse pregnancy outcomes? The study will take place in rural parts of Sindh, Pakistan. These areas often experience extreme heat and have limited access to electricity or cooling systems like fans or air conditioners. This study will include pregnant women who are in their first trimester (under 14 weeks of pregnancy). Before starting any study activities, researchers will explain the study to each woman in a language she understands and ask for her written permission to take part (informed consent). At the beginning of the study, participants will visit a study clinic. During this visit, researchers will check their height and weight, perform an ultrasound, and collect a small amount of blood for testing. Participants will also be asked to wear a small device that measures the air temperature and humidity in their surroundings. The researchers will follow each participant during her pregnancy, with visits during the second and third trimesters at the study clinic. At each visit, researchers will check how much heat the participant has been exposed to using the data from the device and from her own answers to a simple questionnaire. The questionnaire will have questions about their heat exposure at work, home, type of clothing, and how they deal with hot weather. Serial ultrasound, blood and urine tests will be conducted so researchers can study signs of stress, hydration, and other changes in the body. A smaller group of participants will also wear a device to measure their body skin temperature, heart rate, physical activity and sleep during pregnancy. When the baby is born, researchers will collect information about the birth, including the baby's weight and length, the time of delivery, and whether there were any complications during birth. After delivery, both the mother and baby will be followed for up to 12 months. During this time, the research team will check the health of both the mother and baby and see how heat exposure during pregnancy may affect the baby's growth over time. At delivery, placental weight and volume will be collected for a smaller group of women. Breastmilk sampling will also be done for this group of women to understand the effect of high temperatures on breastmilk quality. This study does not involve any treatment or medicine. Instead, researchers will observe the participants to learn how real-life heat exposure affects them during pregnancy. The findings from this study may help public health officials and governments find better ways to protect pregnant women and babies from the harmful effects of climate change and extreme heat, especially in places with limited resources.
NCT06918236
The goal of this prospective cohort study is to examine how different parameters of assisted reproductive technologies (ART) are associated with the perinatal outcome in individuals with singleton or multiple gestations. The main questions it aims to answer are: Are ART pregnancies associated with a higher risk of: * Small for gestational age neonates? * Fetal growth restriction, either early- or late-onset? * Development of preeclampsia? * Stillbirth (intrauterine fetal death after 22 weeks not due to known anomalies)? * Are certain ART parameters-such as the type of fertilization (e.g., IVF vs. ICSI), embryo stage at transfer, use of fresh vs. frozen embryos, or ovarian stimulation protocols-more strongly associated with adverse outcomes? Are ART pregnancies associated with placental and umbilical cord abnormalities, including: * Placenta previa? * Vasa previa? * Single umbilical artery? * Velamentous or marginal cord insertion? Researchers will compare outcomes between pregnancies conceived through ART and those conceived spontaneously. Participants will: * Be individuals aged 18 or older undergoing routine first-trimester ultrasound between 11 and 14 weeks of gestation * Provide detailed medical, obstetric, and ART-related information * Undergo routine prenatal assessments, including ultrasound evaluations of fetal growth, Doppler studies, and placental characteristics * Have perinatal outcomes such as gestational age at birth, mode of delivery, birthweight, and complications systematically recorded Statistical models will be used to adjust for confounding factors such as maternal age, BMI, parity, and smoking. The aim is to better understand how ART and specific ART parameters may influence maternal and neonatal health and to improve counseling and clinical care for people using fertility treatments.
NCT02523222
This was a quasi-experimental pilot study comparing blood glucose values 30 minutes after feeding alone or feeding + dextrose gel in newborns at risk for transient neonatal hypoglycemia.
NCT05043753
The present trial intends to assess the diagnostic accuracy of symphysis fundal height (SFH) as opposed to SFH combined with point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC) in identifying small and large for gestational age infants (SGA and LGA infants) among low-risk pregnant women cared for by midwives after 35 weeks' gestation. Low risk pregnancies will be evaluated at 35-38, 40, 41, and 41+ weeks' gestation by midwives trained in SFH measurement and POC-US. Formal obstetric US performed by a perinatologist (i.e high risk obstetrician) will be performed in case SFH and/or POC-US suspect fetal growth or amniotic fluid abnormalities. Prenatal evaluations will be compared to actual birthweights.
NCT06074601
The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?
NCT05855551
Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh. Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant. A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.
NCT06645717
The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (MRHC) at 2 and or 5,5 years of age.
NCT04720690
Babies may be born appropriately grown for gestational age (AGA, \>10th centile) or small for gestational age (SGA, \<10th centile). Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (FGR). Babies with FGR are at increased risk of cardiovascular disease in adult life. Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. It is not known how early in life these changes can be robustly detected. In addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by SGA or not. This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA. Within the group of SGA babies, the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements. The effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be \<32 weeks gestational age (GA), and half will be ≥32 weeks GA. Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. The study team will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. The Vicorder will also be used to measure cardiac output. The feasibility and validity of this device for this purpose will be investigated (Vicorder is not validated for cardiac output measurement in infants). Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.
NCT01029353
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.
NCT05730569
The aim of the DenBalo study is to apply integrated multi-omics methods to examine the biological mechanisms underlying this vulnerability in Small Vulnerable Newborns (SVNs) in LMICs, with the ultimate goal of identifying targeted interventions to reduce morbidity and mortality in this high-risk population. The evidence generated from this project will ultimately help promote healthy pregnancies and the birth of healthy babies. To achieve this goal, three research objectives are proposed: 1. To describe and compare gut microbiota, immune system and breastmilk components in SVNs versus healthy community controls in urban Burkina Faso. 2. To describe and compare the development of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso. 3. To investigate the relationship between the composition of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.
NCT05670145
Occupational physical activity during pregnancy may decrease blood supply to the uterus and be connected to negative pregnancy outcomes. Every year, this notion prompts many pregnant women to be absent from their workplace in order to protect themselves and their unborn children. However, little is known about the actual extent and impact of physical workloads among expecting mothers in Denmark and whether this high rate of pregnancy related absence is necessary. In consequence, current guidelines from the Danish Working Environment Agency have omitted former limits on lifting during pregnancy due to lack of evidence. (1) Former studies have mainly been based on self-reported data with no measurements of exposures. A comprehensive evaluation of physical exposures in Danish workplaces and potential consequences for pregnant women will provide a rational basis for organization of work with improved options for prevention of adverse health effects. By use of measurements, observations and real-time self-report, the overall aim of the project is to attain precise data on physical workloads (lifting, standing/walking and forward bending) among pregnant employees in the Danish workforce, and investigate how these relate to discomforts, complications and negative pregnancy outcomes.
NCT05612984
This trial will evaluate the impact of an integrated intervention of daily maternal calcium, aspirin, and multiple micronutrients (CAMMS) compared to iron-folic acid (IFA) during pregnancy on preterm birth and other adverse birth outcomes. Both interventions will be delivered through existing antenatal service platforms using context-specific strategies informed by formative research incorporating human-centered design processes to achieve high acceptability and high adherence, in three low-income countries with diverse contexts: Burkina Faso, Pakistan, and Zimbabwe.
NCT05901688
The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical cord coiling index (UCI), umbilical cord (UC) diameter, umbilical vein (UV) diameter, UV flow velocity and the presence of nuchal cord. The UCI, UC, UV diameter \& flow and presence of nuchal cord will be measured in routine unselected populations at 20-22 weeks and 35-37 weeks gestation during the study period. We will also measure the UC and UV diameter in a nested population of high-risk pregnancies attending our placental disorders clinic which have been deemed to be at risk of having adverse pregnancy outcomes. Primary objective: To investigate if prenatal assessment of UCI, UC, UV diameter \& flow and presence of nuchal cord measured routinely in unselected screened populations at 20-22 weeks and 35-37 weeks' can provide an independent prediction of pregnancies that develop adverse pregnancy outcomes. Secondary objectives: To assess the correlation of UC and UV diameter measured by ultrasound scan and fetal magnetic resonance imaging in prediction of pregnancy outcome. To examine the association of these umbilical cord measurements and observations in a nested cohort of pregnancies in the high-risk placental disorders clinic.
NCT03880032
In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.
NCT01578135
This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)