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Depression, Postpartum clinical trials

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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: NCT04093791 Not yet recruiting - Clinical trials for Stress, Psychological

MAMA NO STRESS Project. The Effects of the "HAPPY MAMA" Intervention

Start date: November 2019
Phase: N/A
Study type: Interventional

This study evaluates the effects of a postpartum intervention in increasing the maternal well-being and self-efficacy of Italian women in the first one to six months after childbirth, as well as in reducing postpartum depression and stress. The intervention will use the motivational interviewing against high levels of daily stress. One third of participants will be exposed to a 3,5 hours group intervention approximately 1 month after delivery, one third will be exposed to an individual intervention in the same period and one third will receive no intervention. Participants will be followed with stress and depression questionnaires.

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: NCT04068662 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Intervention for IPV-exposed Pregnant Women

Start date: July 10, 2019
Phase: N/A
Study type: Interventional

The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older. The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).

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.

NCT ID: NCT04043533 Completed - Clinical trials for Depression, Postpartum

The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Aim: This study aims to identify the effectiveness of an exercise program in reducing the severity of postnatal depression in women who had a spontaneous vaginal delivery. Methods: This randomized control trial was conducted with 65 postpartum women residing in a city located in the south-eastern Turkey. In the first postpartum month, following random assignment of subjects, the experimental group (n=40) performed exercises for four weeks, and the control group (n=40) received standard cares. The participating women were administered the Edinburgh Postpartum Depression Scale.

NCT ID: NCT04037085 Completed - Opioid Use Clinical Trials

Ketamine to Improve Recovery After Cesarean Delivery - Part 1

KINETIC
Start date: October 9, 2019
Phase: Phase 2
Study type: Interventional

The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid requirements. In Part 1, physiochemical analysis of pharmacokinetic/pharmacodynamic (PK/PD) and breastmilk transfer of ketamine and its metabolites will be assessed. Additionally calculated estimations for neonatal and infant exposure will be assessed. In Part 2, PK/PD assessments will continue in a larger cohort; endpoints will also include postpartum pain, depression scores, central sensitization measures, patient-reported postpartum recovery scores, breastfeeding, and parent-infant bonding, assessed in the acute post-cesarean period and up to 12 weeks postpartum in a randomized controlled trial.

NCT ID: NCT04017442 Completed - Clinical trials for Postpartum Depression

Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

Start date: October 19, 2019
Phase: Phase 4
Study type: Interventional

Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.