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Showing 1-20 of 398 trials
NCT06277661
The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk for all by increasing patient engagement with evidence-based cilnical and supportive care, thus improving biopsychosocial profiles that drive clinical risk. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of up to 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants during late pregnancy and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.
NCT07487974
This study is to assess the impact of sanitary pads infused with active oxygen and negative ions on episiotomy pain, wound healing, and postpartum physical symptoms in primiparous women. Participants will be randomly allocated to either the intervention group, utilizing active oxygen and negative ion pads, or the control group, employing normal postpartum pads. The research will assess pain intensity, recovery advancement, and physical manifestations during the initial postpartum phase. The objective is to ascertain if the intervention offers supplementary advantages relative to usual care.
NCT06545760
The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are: * Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting? * Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting? * What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting? * What is the prevalence of paternal depression in a low resource setting? * Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge? Researchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings. Participants (infants) will: * At time of discharge from the NICU, when clinically stable, spend either \< 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge. * Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression. * Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.
NCT07543029
Purpose: This is a randomized controlled trial designed to investigate the effects of Kangaroo Mother Care (KMC) applied in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role. Methodology and Sample: Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026. Sample Size: Based on G\*Power analysis (alpha=0.05, power=80%, effect size d=0.566), a total of 112 mothers (56 intervention, 56 control) will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org. Intervention: Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported. Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support). Data Collection Tools: Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).
NCT06312644
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.
NCT03023293
This study aims to investigate the associations of maternal nutritional status during pregnancy and postpartum periods with postpartum abnormal glucose metabolism in Guangzhou pregnant women. Additionally, it seeks to explore the relationships between maternal nutritional status (pre- and postnatal) and offspring health outcomes, including physical growth, neurodevelopment, and common childhood diseases.
NCT06963047
Postpartum hemorrhage and anemia are considered a major health concern due to their impact on maternal morbidity and mortality, quality of life, and maternal cognitive and emotional functioning after delivery, which are particularly important during the critical period of mother-child bonding. Hemoglobin levels in the first 24 hours after delivery do not reflect the lowest point (nadir). The postpartum nadir occurs 48-72 hours after delivery due to the initial redistribution of plasma volume. The aim of this study was to examine whether postpartum ultrasound examination precedes laboratory test results in the diagnosis of anemia due to blood loss after cesarean section.
NCT07018765
This randomized controlled trial aims to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on birth memory and perception of traumatic birth among women who have undergone vaginal delivery. The study will be conducted between July and October 2025 at Malatya Training and Research Hospital. Participants in the intervention group will attend an 8-week MBSR program, while the control group will receive no intervention. Data will be collected using validated scales before and after the intervention. The primary outcomes are changes in birth memory and traumatic birth perception scores.
NCT06284278
The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.
NCT06818734
This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at risk of developing postpartum depression (PPD).
NCT07187544
Postpartum hemorrhage (PPH) is a leading cause of maternal mortality, and its severity has been increasing globally, including in high-income countries. The most common cause of PPH is uterine atony occurring in about 70% of cases. Uterotonic agents, like oxytocin, are key in managing the third stage of labour to prevent PPH. Oxytocin is a short-acting medication and requires frequent dosing, however, carbetocin, a longer-acting analogue that can be administered as a single dose, provides sustained uterotonic activity. Calcium chloride is a readily available, inexpensive medication that has been studied as an adjunct to primary uterotonics due to its role in uterine contractility. A randomized trial found no overall reduction in blood loss with calcium chloride and oxytocin, but a subgroup analysis suggested it may reduce bleeding in cases of uterine atony. This study was conducted in the US where carbetocin is not readily available. The investigators propose a double-blind randomized trial investigating if co-administering calcium chloride with carbetocin during scheduled cesarean deliveries reduces PPH secondary to uterine atony.
NCT06218355
The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
NCT07478055
Participants are recruited for a research study about how lab values change following delivery in people with Preeclampsia with Severe Features. Preeclampsia with Severe Features means that the disease has impacted organs, causing high blood pressures, symptoms, or changes in lab values. Those with Preeclampsia with Severe Features receive magnesium sulfate after delivery. The study is intended to learn how lab values change following delivery and to investigate how quickly participants get better from preeclampsia. Participation in this research will last while admitted to the hospital. Information will be collected from the post partum visit, but there is no need for blood draw at that time. The purpose of this research is to gather information on the safety and effectiveness of a shorter administration of magnesium which is approved by the Food and Drug Administration (FDA). Participants will be randomized into two groups, which means that it will be decided by chance if 12 hours or 24 hours of magnesium will be given after the delivery of the baby. Blood samples will be collected at time of delivery, 12 hours after delivery, 18 hours after delivery, 24 hours after delivery, and then daily. This is very similar to the number of labs to be collected even if participants decide not to participate in this study. This would likely add 2 or 3 blood draws. Both groups will have the same number of blood draws collected. Other than possibly having 12 hours of magnesium, and a few more blood draws, the rest of the care received will not change. Each blood draw will consist of \~10mL, meaning a total of about 40mL of blood would be drawn for the purpose of this study. Data would be collected, and deidentified. Information collected would include age, other medical conditions (like diabetes or high blood pressure out side of pregnancy), blood pressure, and symptoms during hospital stay and at the post partum visit.
NCT07185204
The goal of this study is to address the significant morbidity associated with preeclampsia diagnosed after delivery. All participants will undergo biomarker evaluation with soluble fms-like tyrosine kinase-1 and placental growth factor (sFlt-1/PlGF) ratio testing before delivery to assess the predictive ability of these biomarkers with new-onset postpartum preeclampsia. High-risk participants will be randomized to a bundle of care strategies aimed at early detection and management of postpartum preeclampsia.
NCT05849103
Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.
NCT05073224
This study will evaluate lower extremity and trunk neuromuscular control in 78 nulligravid and postpartum women. Participants will attend two experimental sessions, approximately 1 week apart, to assess neuromuscular function. Physical activity levels will also be assessed.
NCT07192718
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) and educational content on global postpartum recovery at 12 weeks post cesarean delivery.
NCT07460921
The population of the study, planned as a randomized controlled experimental design, consists of primiparous women who gave birth in the delivery unit of Istanbul Esenler Women's Health and Pediatric Diseases Hospital. The sample of the study will be composed of 110 postpartum women who meet the sampling criteria, are willing to participate, and are determined by power analysis. The study includes two groups: the "intervention group (n=55)," who will receive discharge education through podcasts in the early postpartum period, and the "control group (n=55)," who will receive routine discharge education. Women in the intervention group will listen to four podcasts, each lasting 5-6 minutes, about discharge education during the early postpartum period. Before the data collection forms are applied, participants will be asked to complete an "Informed Consent Form." All groups will be evaluated with the "Edinburgh Postpartum Depression Scale," the "Maternal Attachment Scale," and the "Self-Care Agency Scale" both before and after the intervention. The discussion and conclusions of the study will be written based on the results obtained.
NCT07436286
This randomized controlled clinical trial evaluates the effect of umbilical vein injection of oxytocin given in addition to routine active management of the third stage of labour. The third stage of labour is associated with a risk of postpartum haemorrhage, a major cause of maternal morbidity and mortality, particularly in low-resource settings. Active management with intramuscular oxytocin and controlled cord traction is standard practice, but additional measures that can further reduce blood loss may improve maternal outcomes. Eligible women undergoing vaginal delivery were randomly assigned to receive either an intra-umbilical injection of oxytocin diluted in normal saline or a placebo injection of normal saline, alongside standard active management of the third stage. The main outcomes assessed were postpartum blood loss, duration of the third stage of labour, and change in maternal haemoglobin concentration within 24 hours after delivery. The study aims to determine whether local administration of oxytocin through the umbilical vein can enhance uterine contraction, promote placental separation, shorten the third stage of labour, and reduce postpartum blood loss compared with standard care alone.
NCT05285215
The integrated psychological program (IPP) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. Incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic. The proposal will transform the healthcare model for treating postnatal depression (PND) and persistent postpartum pain (PPP).