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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.
NCT06148831
Suboptimal postpartum health outcomes in the US, including low rates of lactation and high rates of postpartum depression, contribute to high rates of perinatal mortality and morbidity as well as long-term and intergenerational health outcomes. Black birthing parents and infants are at the highest risk, with the lowest rates of lactation and the highest rates of postpartum depression. Yet most interventions to support lactation and postpartum mental health are based on models of care that are unrepresentative of Black and global majority communities. The principal investigator's previous Randomized Controlled Trial (RCT) using soft infant carriers to increase parent-infant physical contact was effective in increasing lactation and decreasing postpartum depression in a sample of Latinx postpartum parents. Infant carrying, or "babywearing," is a culturally relevant prevention strategy based on models of parenting representative of Black and global majority communities. In this study, the investigators use strategies from implementation research and clinical effectiveness research to assess an infant carrier intervention within a community-based, culturally specific perinatal home visiting program for Black birthing parents.
NCT07300176
The research will be conducted as a prospective, observational, and comparative study with 98 pregnant volunteers aged 18-45 at Düzce University Faculty of Medicine. Participants will be divided into a VR group and a control group. Data will be collected using STAI-I, EPDS, NRS scales, and biochemical analyses (tryptophan, kynurenine, etc.). Upon completion, the project is expected to contribute to non-pharmacological approaches and new care protocols for reducing postpartum depression.
NCT07292649
Postpartum Depression (PPD) is defined as the development of depression at any time during the first year after childbirth¹. Its prevalence ranges from 15% to 20%. It can manifest with symptoms such as depressed mood, loss of interest and energy, insomnia, anxiety, and may even lead to suicidal ideation. The consequences are numerous, both physical and psychological, with long-term repercussions on the mother-infant bond, family dysfunction, and the development of emotional and cognitive disorders in children. The etiology of PPD is multifactorial, but numerous recent studies have focused on the role of labor pain and its management with labor analgesia techniques. The aim of the present study is therefore to assess whether there is a difference in the incidence of PPD between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.
NCT06831968
The goal of this observational study is to develop a blood test that may be predictive of postpartum depression. This Blood test is investigational and not yet FDA approved. Participants will not receive the results of this blood test. Up to 500 pregnant women will be recruited for the study from 2 sites. Participants must be age 18 or above with a singleton pregnancy and able to provide written consent in English. The Objective of this Clinical Trial is to prospectively validate the Enlighten Device test by prospectively determining false/true positive and negative rates. Building off of this, an exploratory objective of this study is to examine clinical factors associated with false positive/negative rates. This project will address the following Aim: Aim 1: Prospective collection of true/false positive and negative PPD outcomes through 6 months postpartum. Primary Hypothesis H1a: 80% or greater of pregnant women who develop PPD by 3 months after delivery will be determined to be Biomarker Positive by the Enlighten Device in T3. Primary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Device in T3 will develop PPD by 3 months after delivery. Exploratory Aim 1: Investigation of clinical factors that may be associated with false positive and false negative rates, such as: medication use, stressful life events, and sociocultural context. Participants will be screened during the second or third trimester and enrolled during the third trimester, before week 30 weeks of gestation. Participants may self- identify through study advertisements in participating clinics, social media outlets, and community outreach efforts. Enrolled participants will undergo blood collection during their 3rd trimester (\~27-30 weeks, a standard pregnancy-related blood collection timepoint) for completion of the Enlighten Device test, the blood-based epigenetic biomarker test. Participants will then be interviewed at 2 weeks, 6 weeks, 3 months, and 6 months postpartum for the development of depression symptoms. They'll also complete a multitude of other outcome measures at each of these visits.
NCT05585164
This randomized controlled trial compares a novel psychotherapy, Engage \& Connect, with a Symptom Review and Psychoeducation intervention, tailored to reduce postpartum depression. The study includes 9-weeks interventions, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.
NCT02614547
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.
NCT07167654
Effectiveness of a Smartphone Application for Mothers at High Risk for Postpartum Depression: A Randomized Controlled Trial Abstract Aim: This study aims to determine the effectiveness of a smartphone application in reducing symptoms of postpartum depression among Jordanian women. Background: Postpartum depression (PPD) is a serious mental health condition affecting an estimated 14-27% of mothers and negatively impacting infant health. Social support and certain psychological therapies have been shown to reduce depressive symptoms in postpartum women. Smartphone applications may provide a viable means of delivering psychological interventions to mothers experiencing such symptoms. Method: A randomized controlled trial will be conducted at two maternal and child health clinics in Irbid, Jordan. A total of 295 women will be invited to participate and will be asked to provide sociodemographic data and complete the Edinburgh Postnatal Depression Scale (EPDS) at 6-8 weeks (baseline) and again at 3 months postpartum. Women with a depressive symptom score of ≥13 (n ≈ 79) will be randomly assigned to either the intervention group (n ≈ 58) or the control group (n ≈ 57). The intervention will involve an Android smartphone application called Serene Motherhood, which will enable mothers to access evidence-based cognitive techniques and health information at any time.
NCT05423093
The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary care. The virtual session is intended to (1) enhance patient/family education about postpartum depression (PPD) and (2) Provide an orientation to families regarding relevant clinic and community psychosocial support resources available. The investigators will conduct a single-arm, open pilot of the session, which will be co-delivered by existing clinic staff (including social work and community outreach staff). Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs. The overall aim of the project is to Develop and pilot a virtual group augmentation of standard individual well-child care to improve (1) clinic screening procedures, discussion about and initial management of maternal depressive symptoms with immigrant Latinas and (2) patient symptom recognition, symptom disclosure, and subsequent treatment engagement
NCT06144294
This study aims to examine the scientific mechanisms of whole-body hyperthermia (WBH), a novel, rapidly acting, single session antidepressant and anxiolytic therapy. It also aims to determine its feasibility and acceptability in women with postpartum depression (PPD). The study will enroll four cohorts of participants: healthy postpartum controls; postpartum women with PPD; healthy adult controls; and adults with major depressive disorder or anxiety disorders in a longitudinal protocol.
NCT06365645
Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers \& Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention.
NCT04821544
The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.
NCT05622305
Public Health Nurses (PHN) received training to deliver a day-long Cognitive Behavioural Therapy (CBT)-based workshop for treating postpartum depression (PPD). Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months later. The study will aim to determine if online day-long CBT-based workshops delivered by public health nurses can be added to treatment as usual to improve postpartum depression more than treatment as usual alone, iif the workshops are cost-effective, and if the workshops can stably improve depression, its common comorbidities and reduce adverse effects on the family. Hypotheses: Online 1-Day CBT-Based Workshops delivered by PHNs will be an effective (and cost-effective) way to stably improve PPD, its comorbidities, and reduce its adverse effects on the family.
NCT05551195
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
NCT06544941
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.
NCT05543746
This is a feasibility study of performing repeated EEG recordings and assessment of affective states during open-label administration of BRX to women with postpartum depression. Study phases will include screening, enrollment, intervention, and follow-up. Subjects will be screened for study eligibility criteria through clinical assessments and self-report. Enrolled subjects will be admitted to the UNC Women's Hospital, where five serial EEG recordings will be obtained, along with frequent assessments of affective state, before, during, and after a 60-hour IV infusion of BRX. Follow-up procedures will include assessments of PPD and affective symptoms, as well as an exit interview with the study team. If feasibility outcomes are achieved, exploratory EEG analyses will be performed with AMICA (adaptive mixture independent component analysis), community detection, and microstate assessment. Exploratory analyses of data collected by facial expression detection software (iMotions Affectiva) are also planned.
NCT05873569
Postpartum depression (PPD) affects 10-20% of women, with immigrant Latinas disproportionately affected. PPD prevention and treatment is limited among immigrant Latinas due to an array of structural and cultural factors, suggesting the need to deliver interventions outside of traditional healthcare settings. Virtual interventions have the potential to reduce barriers to mental health services for immigrant Latinas, but there is little research on the effectiveness of virtual interventions to reduce PPD symptoms. Mothers and Babies is an evidence-based group intervention based on principles of cognitive-behavioral therapy and attachment theory aimed at PPD prevention. Mothers and Babies was adapted for delivery via a virtual group format (Mothers and Babies Virtual Group; MB-VG), with a pilot study suggesting good feasibility and acceptability as well as improved mental health outcomes for immigrant Latinas. The proposed project is a Type 1 Effectiveness-Implementation randomized controlled trial among pregnant individuals and new mothers at risk for PPD based on elevated depressive symptoms and/or other established risk factors who are enrolled in early childhood programs across Maryland. A total of 300 women will be enrolled; 150 will receive MB-VG while 150 will receive usual family support services. The project aims to evaluate: 1) the effectiveness of MB-VG to reduce depressive symptoms, prevent onset of PPD, and improve parenting self-efficacy and responsiveness; 2) implementation of MB-VG; and 3) contextual factors influencing MB-VG effectiveness and implementation. Trained early childhood center staff will deliver MB-VG sessions, with intervention participants receiving virtual group sessions via Zoom using any electronic device (smartphone, tablet, laptop). Maternal self-report surveys are conducted at baseline, 1 week, 3 months, and 6 months post-intervention, with structured clinical interviews also conducted at 3- and 6-months post-intervention. The study is the first to deliver a virtual PPD preventive intervention to immigrant Latinas and to evaluate its impact. Given its virtual delivery modality, MB-VG can be easily replicated and scaled to other family support programs and settings serving immigrant Latinas. If effective and implemented broadly, more immigrant Latinas will receive mental health services and fewer will suffer the negative consequences associated with PPD.
NCT06727760
Background: Infantile colic is a condition characterized by inconsolable crying in infants under three months of age. Purpose: The aim of this study is to determine the effects of colic massage and kangaroo care on infantile colic symptoms, crying, and sleep duration. Method: Our study was conducted at the Child Health and Diseases Polyclinic of Atatürk city Hospital between March 2022 and April 2023. The study sample consisted of infants diagnosed with infantile colic who applied to the polyclinic and their mothers. 96 infants were randomly selected in our study using the randomization method. They were assigned to the massage, kangaroo care, and control groups. Infants in the colic massage and kangaroo care groups received interventions for 15-20 minutes in the morning and evening, while the control group received no intervention. Before the intervention, crying and sleep duration were monitored and recorded for 24 hours for one week in all three groups. Mothers continued the massage and kangaroo care application for 3 weeks. In the 3rd week of the application, 24-hour crying and sleep duration were recorded again for one week. Before and after the interventions, the Infantile Colic Scale (ICS) was applied to all three groups. The three groups were compared with the Wilcoxon test.
NCT06682689
The aim of the study is to explore whether transcutaneous vagus nerve stimulation (tVNS) may be effective in preventing mood swings and depressive symptoms in the postpartum phase, as well as serving as a supplementary intervention in cases where mood symptoms develop. The study will investigate the effects of tVNS intervention during the first 12 weeks postpartum. Pregnant women will be recruited for the study, and the intervention will begin shortly after giving birth. Participants will receive different instructions on how to use the tVNS device. Additional parameters such as physiological functions, chronic stress, hormones, environment, and personality traits will also be assessed.
NCT06651424
The objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.