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Depression, Postpartum clinical trials

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NCT ID: NCT04227704 Completed - Clinical trials for Postpartum Depression

Ketamine to Prevent PPD After Cesarean

PoCKet
Start date: November 12, 2020
Phase: Phase 3
Study type: Interventional

The investigators plan to randomise participants to receive ketamine or placebo control subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to assess the incidence of postpartum depression. This feasibility pilot study is designed to explore the adequacy of the study procedures and tolerability of the interventions.

NCT ID: NCT04169334 Completed - Clinical trials for Depression, Postpartum

Look - Your Baby is Talking to You.

Start date: September 19, 2019
Phase: N/A
Study type: Interventional

It is well documented that the formation of the early relation between parents and infant has a significant impact on the child's mental, social and cognitive development and competencies. The early relationship formation in the first year in the infants' life gets the best conditions when parents are able to interpret, understand and respond to the infants signal adequately. Symptoms of mental illness can affect a person's ability to respond to their environment and thereby their parenting capabilities. Research have found that parental psychopathology may interfere with a healthy interaction with the infant by reducing the ability to be sensitively attuned and responsive to the infant's signal, needs and cues due to the nature of the psychiatric symptoms. The aim of this study is to investigate what potential lies within the postpartum stay at the obstetric department and in the transition to the primary health care sector for vulnerable families and to develop an intervention that will help increase the parents sensitivity towards their new born infant in order to enter a healthy early relationship formation which will be measureable on short term in the prevalence of maternal post-partum depression. The study is a prospective mixed-method study consisting of three sub-studies. The first study is a register-based study which aims to investigate how the proportion and the absolute risk of children with predefined adverse developmental outcomes is distributed between families defined as level three or four compared to families defined as level one and two. The second study aims to uncover needs and preferences of the vulnerable families and to investigate the experiences of the health care professionals. It is explored by in-depth family interviews with families discharged from the obstetric department and focus group interviews with health care professionals (nurses and health visitors) who are responsible for the care delivered to vulnerable families. Subsequently an intervention study will be developed, adapted, implemented and evaluated. The intervention will be carried out at the obstetric department at Hvidovre hospital and in transition to the primary healthcare sector using components from family focused nursing (FFN) and neonatal behavioral observational sessions (NBO) in addition to what have appeared in the two first sub-studies. The aim of the intervention is to facilitate family consciousness of their resources'' and increase parental sensitivity in order to foster the best possible prerequisites for a healthy early relationship formation between parent and infant. The study population consists of mothers with anxiety or depression diagnosis giving birth at Hvidovre hospital. The register-based study will provide population based information on the characteristics of vulnerable families focusing on the adverse outcomes for the children. The qualitative interviews will contribute with in-depth knowledge about preferences and experiences in relation to the care offered within the extended stay at the obstetric department and in the transition to primary health care sector and everyday life for vulnerable families. The enactment, implementation and evaluation of the intervention will determine whether the combination of FFN, NBO and improved collaboration between the obstetric department and the health visitor is associated with increased family function and increased parental sensitivity among parents in the intervention group compared to the control group. Effect from baseline (24-48 hours post-partum) to follow-up (3 months post-partum) will be measured on both the mother, the parents and the infant focusing on depression symptoms (primary outcome), parental stress, parental reflective function, mother-baby interaction, couple relationship satisfaction, infants' self-regulation, family function and breastfeeding Descriptive statistics will be applied in order to detect associations. Power calculations showed that with a significance level of 5% and a power of 80% 55 families are needed in the control and the intervention group, respectively, in order to detect statistically difference. This PhD study will contribute with a new perspective on the potential of the time immediately after birth and the potential effect of early intervention to improve prerequisites for increased family function and early healthy relationship formation for vulnerable families. The study will provide knowledge and experience about the practical application of both FFN and NBO at the obstetric department which have never been done in a Danish context before. It is expected that the study as a whole may impact and benefit clinical nursing as well a public health.

NCT ID: NCT04167709 Completed - Clinical trials for Depression, Postpartum

CHS Nurses Clinical Competence in Detecting Signs of PPD in Non-Native Speaking Immigrant Mothers'

Start date: June 9, 2019
Phase: N/A
Study type: Interventional

The aim is to develop, test and evaluate an educational intervention with the purpose to strengthen Child Health Services (CHS) Nurses clinical competence in detecting signs of postpartum depression in non-native-speaking immigrant mothers. The pilot study has a pre-post experimental design. Data are collected before and after the intervention. The differences in the values of the collected data are used to estimate the effect of the intervention.

NCT ID: NCT04146025 Completed - Pregnancy Related Clinical Trials

Nurtured in Nature

Start date: September 12, 2019
Phase: N/A
Study type: Interventional

The investigators pilot test a Nature Coach Intervention in a population of postpartum women, to increase the amount of time people spend outside in local nature, with the goal of preventing postpartum depression.

NCT ID: NCT04135612 Completed - Clinical trials for Post Partum Depression

The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates

Start date: October 30, 2019
Phase: N/A
Study type: Interventional

We will aim to study the impact of introducing a smartphone-based daily feedback and communication platform between postpartum women delivering at our institute and a multidisciplinary breastfeeding-support team (obstetricians, neonatologists, midwives, lactation consultants, nurses, and psychologist) on breastfeeding rates.

NCT ID: NCT04108533 Completed - Breastfeeding Clinical Trials

Lactation Achievement With Texts at Home

LATcH
Start date: January 6, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to determine if text-based breastfeeding support improves breastfeeding initiation, exclusivity, and duration when compared to usual postpartum care. All women without a contraindication to breastfeeding and access to a mobile phone with unlimited text messaging capability who deliver a healthy term neonate will be eligible for inclusion. Consented women will be randomized to either text-based breastfeeding support using the Way to Health platform or usual care.

NCT ID: NCT04087317 Completed - Pain Clinical Trials

Vaginal Postpartum Pain Management Protocol Comparison

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.

NCT ID: NCT04073043 Completed - Anxiety Clinical Trials

Telephone Coaching Intervention for Postpartum Depression and Anxiety

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

Mental health problems affect up to 20% of women at some point during the perinatal period (i.e., from pregnancy to one year postpartum. Perinatal mental health (PMH) problems have been associated with many negative obstetric outcomes, such as higher elective caesarean section, premature delivery, pre-eclampsia, lower fertility rates, and longer postpartum hospital stay. This research study is a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential benefits of a low cost sustainable web-based intervention (WBI) with telephone coaching for women with mild to moderate symptomatology of postpartum depression and anxiety. The intervention contains modules that will help postpartum mothers: 1. Learning new information to better understand their condition. This can help mothers feel that they are not alone, and that their experience is not abnormal. It gives a better understanding that can help them feel more confident in their communications with health care professionals and can make it easier to share their experience with family and friends. 2. Learning and practicing new skills. This can help mothers feel confident that they can engage in the behaviours that have been shown to be beneficial for mood and to improve stress. This can include learning to plan activities like physical exercise, practice proper sleep hygiene or learning to use a new way of thinking about problems to help you find solutions. This trial represents a first step to implement a sustainable intervention for PMH problems in order to better serve women's PMH needs and preferences for support. This will help inform the current gap in low cost web-based interventions for PMH.Specific deliverables (in both French and English) include: a manual detailing coaching procedures; reports for decision makers and short summaries for stakeholder groups

NCT ID: NCT04051320 Completed - Depression Clinical Trials

Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model

Start date: January 2, 2020
Phase: Phase 2
Study type: Interventional

The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritability in past studies, will be used to examine the neurocircuitry underlying irritability under baseline and hormone challenge conditions among women who are hormone sensitive (HS+; n=15) and non-hormone sensitive (HS-; n=15). The long-term goal of this research is to advance understanding of the neural systems underlying both the triggering of and susceptibility to irritability in women. The objective of the current project is to examine whether HS+ show differences in the behavioral activation system relative to HS- under baseline and hormone challenge conditions using functional magnetic resonance imaging (fMRI) and behavioral tests.

NCT ID: NCT04045132 Completed - Parenting Clinical Trials

Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms

Start date: December 17, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a social media-based parenting program can improve responsive parenting among mothers with Postpartum depression (PPD) symptoms. Participants will be randomized to receive the parenting program plus online depression treatment or online depression treatment alone to assess target engagement. Our overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone.