Tender Loving Care for Miscarriage
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Walter Reed National Military Medical Center
Disqualifiers: Age, Smoker, Uterine anomaly, others
No Placebo Group
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.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems to focus on participation in a messaging platform rather than medication changes.
What data supports the effectiveness of the Tender Loving Care treatment for miscarriage?
Research shows that nursing interventions, like those in the Tender Loving Care treatment, can improve patients' ability to care for themselves and their overall health. This suggests that supportive care and messaging, similar to the TLC intervention, may help individuals cope better with health challenges.12345
How is the Tender Loving Care Intervention different from other treatments for miscarriage?
The Tender Loving Care Intervention is unique because it focuses on providing emotional support and practical advice through a messaging platform, rather than relying solely on medical treatments. This approach emphasizes patient-centered care by addressing the emotional and psychological needs of women experiencing miscarriage, which is often overlooked in traditional medical treatments.678910
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.Inclusion Criteria
Able to speak and understand English
Pregnant individuals receiving their prenatal care at WRNMMC
Less than or equal to 10+0 weeks gestation by last menstrual period (LMP) or dating ultrasound at the time of enrollment
See 1 more
Exclusion Criteria
Unable to speak or understand English
Current smoker or tobacco use within 30 days
Suspicion for or confirmation of an ectopic pregnancy
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants interact with weekly messages providing prenatal counseling and support
1 year
Weekly interactions (online)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 weeks after delivery or miscarriage
Repeat assessments at 13 weeks, 28 weeks, and 6 weeks after delivery or miscarriage
Treatment Details
Interventions
- Tender Loving Care Intervention (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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
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 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.
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.
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.
Restoring power through nursing intervention. [2019]To test the effectiveness of seven therapeutic nursing interventions in alleviating powerlessness in chronically ill clients was tested.
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.
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.
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?
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.
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.