Trial Summary
What is the purpose of this trial?The goal of this investigational study is to evaluate participation in a weekly, interactive, tender loving care messaging platform impact on pregnancy outcomes in patients with recurrent pregnancy loss.
The main questions it aims to answer are: (1) does participation in weekly, interactive tender loving care messages increase live birth rates in patients with recurrent pregnancy loss? (2) Does participation in weekly, interactive tender loving care messages increase patients' quality of life? Does participation in weekly, interactive tender loving care messages decrease patients' depressive symptoms?
Participants will be asked to interact with weekly messages providing prenatal counseling and support. Additionally, patients will be asked to complete the fertility quality of life survey several times over the course of the pregnancy.
Is the Tender Loving Care Intervention a promising treatment for miscarriage?Yes, the Tender Loving Care Intervention is a promising treatment for miscarriage because it focuses on providing supportive care, which many women with recurrent miscarriages prefer. This includes emotional support, practical advice, and frequent check-ins, which can help women feel more supported and cared for during their pregnancies.56101114
What safety data exists for Tender Loving Care for Miscarriage?The provided research does not contain specific safety data for Tender Loving Care for Miscarriage or its related interventions. The articles focus on trauma-informed care, birth trauma, PTSD interventions, and intimate partner violence, but do not directly address the safety of the Tender Loving Care interventions.89121315
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on messaging support, so you might not need to change your medications, but it's best to ask the trial coordinators for confirmation.
What data supports the idea that Tender Loving Care for Miscarriage is an effective treatment?The available research does not provide specific data on the effectiveness of Tender Loving Care for Miscarriage. The studies mentioned focus on nursing interventions in general, such as exercise promotion and wound care, but do not directly address Tender Loving Care for Miscarriage. Therefore, there is no direct evidence from the provided information to support its effectiveness for miscarriage.12347
Eligibility Criteria
This trial is for pregnant individuals who are less than 10 weeks along, have had at least two prior pregnancy losses confirmed by medical records or ultrasound, and can speak English. They must be getting prenatal care at WRNMMC.Exclusion Criteria
I am between 18 and 44 years old.
I have a history of reproductive or immune system health issues.
I have had treatments that could affect my reproductive organs or a cancer in my reproductive system.
Treatment Details
The study tests if a weekly tender loving care messaging platform can improve live birth rates, quality of life, and reduce depressive symptoms in patients with recurrent pregnancy loss. Participants will receive prenatal counseling and support through messages.
1Treatment groups
Experimental Treatment
Group I: Tender loving care interventionExperimental Treatment1 Intervention
Weekly prenatal counseling messages sent via an online platform.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Walter Reed National Military Medical CenterBethesda, MD
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Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
References
Restoring power through nursing intervention. [2019]To test the effectiveness of seven therapeutic nursing interventions in alleviating powerlessness in chronically ill clients was tested.
British studies which measure patient outcome, 1990-1994. [2019]In order to assess the context and use of patient-outcome measurement in nursing. British studies reported in Nursing Research Abstracts, published by the Department of Health in the 5-year period between January 1990 and December 1994 which measured patient outcome were retrieved, and analysed in relation to the nursing specialty, intervention and outcome variables, and method of measurement used. A total of 228 studies which measured patient outcome were identified, which included 516 occurrences of patient-outcome measurement. Fifty per cent of studies measured a single outcome variable. Physical health status and psychosocial functioning outcomes accounted for over half of the total number of variables used, with generic well-being measures least frequently used; 38% of the studies utilized existing outcome measurement tools, or researcher-constructed tools which had been tested for reliability and validity; 62% utilized tools constructed specifically for the study or physiological/biochemical measures. There was variation in the frequency of use of multiple outcome variables and existing measurement tools between different clinical specialties. The 228 studies included 119 different outcome-measurement tools/instruments, with only 20 measurement tools used more than once. The analysis identified a large range of patient-outcome variables and measurement tools included in nursing studies, but little coherence in definition and method of measurement between studies.
Relationship between nursing interventions and outcome achievement in acute care settings. [2022]The extent to which nursing interventions provided during hospitalization are associated with patients' therapeutic self-care and functional health outcomes was explored with a voluntary sample of 574 patients. Nurses collected data on patient outcomes at admission and discharge using the minimum data set (MDS) and the therapeutic self-care scale (TSCS). Research assistants audited charts for documentation of nursing interventions. The results indicated that nursing interventions aimed at exercise promotion, positioning, and self-care assistance predicted functional status outcome. Higher functional status outcome predicted therapeutic self-care ability at hospital discharge. The results demonstrate that nurses can use MDS and TSCS data on patient outcomes to gain insight into the effectiveness of their interventions.
Nursing-sensitive patient outcomes: the development of the Putting Evidence into Practice resources for nursing practice. [2019]The Oncology Nursing Society (ONS) has worked diligently to improve the care of patients with cancer and their families. A recent project that demonstrates this commitment toquality care is the development of nursing-sensitive patient outcomes resources. ONS has teamed researchers, advanced practice nurses, and staff nurses to develop Putting Evidence Into Practice resources that provide guidance for nursing interventions based on the evidence. The ability to provide evidence for nursing interventions is critical to all aspects of patient care, including patient teaching, development of patient care policies and procedures, and provision of direct patient care.
Supportive care for women with unexplained recurrent miscarriage: patients' perspectives. [2022]BACKGROUND Supportive care is currently the only 'therapy' that can be offered to women with unexplained recurrent miscarriage (RM). What these women themselves prefer as supportive care in their next pregnancy has never been substantiated. Therefore the aim of this study was to explore what women with unexplained RM prefer as supportive care during their next pregnancy. METHODS We performed explorative, semi-structured, in-depth interviews. The interviews were performed with 15 women with unexplained RM who were actively seeking conception. All interviews were conducted by telephone. The interviews were fully transcribed and two researchers independently identified text segments from the transcribed interviews and categorized them in the appropriate domain. RESULTS Women identified 20 different supportive care options; 16 of these options were preferred for their next pregnancy. Examples of the preferred supportive care were early and frequently repeated ultrasounds, βHCG monitoring, practical advice concerning life style and diet, emotional support in the form of counselling, a clear policy for the upcoming 12 weeks and medication. The four supportive care options that were not preferred by the women were admittance to a hospital ward at the same gestational age as previous miscarriages, Complementary Alternative Medicine, ultrasound every other day and receiving supportive care from their general practitioner. CONCLUSIONS Our study identified several relevant preferences for supportive care in women with unexplained RM. Many of these can be offered by the gynaecologist and will help in guaranteeing high-quality patient-centred care.
Supportive care for women with recurrent miscarriage: a survey to quantify women's preferences. [2022]Supportive care is regularly offered to women with recurrent miscarriages (RMs). Their preferences for supportive care in their next pregnancy have been identified by qualitative research. The aim of this study was to quantify these supportive care preferences and identify women's characteristics that are associated with a higher or lower need for supportive care in women with RM.
Nursing interventions and outcomes classifications in patients with wounds: cross-mapping. [2017]Objective Cross-mapping of terms referring to nursing interventions and outcomes in the medical records of patients with wounds compared to nursing interventions and nursing outcomes classifications. Method An observational retrospective study based on cross-mapping. The sample consisted of 81 outpatients treated in a university hospital in Rio de Janeiro. Data was collected from medical records between May and July of 2013. The analysis was done in four steps: search for phrases used to describe interventions and outcomes; setting the frequency of occurrence of phrases; grouping synonyms; comparison of terms with taxonomies. Results 13 interventions were mapped and the most frequent was "Care with wounds" (47.23%). Also, 6 results were mapped and the priority was "Wound healing: secondary intention" (45%). Conclusions The use of cross-mapping of terms referring to interventions and nursing outcomes in patients with wounds suggested additions to the taxonomies for adaptation to outpatient care.
Birth as Restorative. [2019]A woman's past history of sexual trauma is inextricably woven into her pregnancy and birth experience. Two cases are presented by a practicing certified nurse midwife to demonstrate trauma-informed care in the childbearing setting. Providing trauma-informed care universally in the women's healthcare setting is imperative given not all women disclose their history. Empowering survivors may allow for a restorative birth, in which trust of one's own body can be regained.
Efficacy of a Web-Based Safety Decision Aid for Women Experiencing Intimate Partner Violence: Randomized Controlled Trial. [2019]Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families.
Recurrent pregnancy loss: couples' perspectives on their need for treatment, support and follow up. [2020]What do couples referred to or attending a recurrent pregnancy loss (RPL) clinic believe they need in terms of treatment, support and follow up?
Recurrent miscarriage: evidence to accelerate action. [2022]Women who have had repeated miscarriages often have uncertainties about the cause, the likelihood of recurrence, the investigations they need, and the treatments that might help. Health-care policy makers and providers have uncertainties about the optimal ways to organise and provide care. For this Series paper, we have developed recommendations for practice from literature reviews, appraisal of guidelines, and a UK-wide consensus conference that was held in December, 2019. Caregivers should individualise care according to the clinical needs and preferences of women and their partners. We define a minimum set of investigations and treatments to be offered to couples who have had recurrent miscarriages, and urge health-care policy makers and providers to make them universally available. The essential investigations include measurements of lupus anticoagulant, anticardiolipin antibodies, thyroid function, and a transvaginal pelvic ultrasound scan. The key treatments to consider are first trimester progesterone administration, levothyroxine in women with subclinical hypothyroidism, and the combination of aspirin and heparin in women with antiphospholipid antibodies. Appropriate screening and care for mental health issues and future obstetric risks, particularly preterm birth, fetal growth restriction, and stillbirth, will need to be incorporated into the care pathway for couples with a history of recurrent miscarriage. We suggest health-care services structure care using a graded model in which women are offered online health-care advice and support, care in a nurse or midwifery-led clinic, and care in a medical consultant-led clinic, according to clinical needs.
Intimate partner violence and trauma-informed care in pregnancy. [2022]Intimate partner violence is defined as any behavior within an intimate relationship that causes physical, psychological, or sexual harm to those in the relationship. Globally, women are disproportionately victims of intimate partner violence. The risk increases during pregnancy, with estimated rates of as high as 20% among pregnant persons. Intimate partner violence is associated with adverse perinatal outcomes, including perinatal and maternal death. Given that pregnancy is a period of frequent interaction with the healthcare system, it is an opportune time to screen and intervene for intimate partner violence. Universal screening at the first prenatal visit and subsequently every trimester is recommended, with either written or verbal validated tools. Pregnant persons experiencing intimate partner violence need nonjudgmental, compassionate, confidential, and trauma-informed care. The goal of this review is to outline pregnancy-specific care considerations.
The Survivor Moms' Companion Trauma-Specific Perinatal Psychoeducation Intervention in a Community Outreach Program: An Open Pilot. [2022]Posttraumatic stress disorder (PTSD) confers significant risk during the childbearing year, including for maternal substance use, inadequate prenatal care, preterm birth, and impaired maternal-infant bonding. Although several treatments are available for PTSD, few are specific to the perinatal period. The purpose of this pilot study was to evaluate outcomes of a PTSD- and pregnancy-specific psychoeducational intervention, the Survivor Moms' Companion (SMC).
Factors that shape recurrent miscarriage care experiences: findings from a national survey. [2023]Learning what matters to women/couples with recurrent miscarriage (RM) is essential to inform service improvement efforts and future RM care practices. Previous national and international surveys have examined inpatient stays, maternity care, and care experiences around pregnancy loss, but there is little focus on RM care. We aimed to explore the experiences of women and men who have received RM care and identify patient-centred care items linked to overall RM care experience.
Reducing the Adverse Effects of Birth Trauma Among Birth Companions. [2023]Birth trauma affects the entire family, yet limited attention has been directed to how nurses influence the experiences of birth companions. Therefore, the purpose of this article is to increase awareness of birth trauma among birth companions and provide nursing strategies to reduce the adverse effects of traumatic childbirth among birth companions. I review background information describing birth companions' perceptions of childbirth as traumatic and the implications of birth trauma. I then present protective nursing strategies before, during, and after birth, followed by a discussion on implications. Lastly, I offer a summary of protective nursing strategies, an example of postnatal debriefing using the adapted ASSIST communication tool, and available online birth companion resources.