Tender Loving Care for Miscarriage

Overseen By David Boedeker, DO

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Walter Reed National Military Medical Center

Disqualifiers: Age, Smoker, Uterine anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 1 year

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether regular, supportive messages can improve pregnancy outcomes for individuals who have experienced recurrent pregnancy loss. Participants receive weekly messages offering prenatal advice and emotional support through the Tender Loving Care Intervention. The study examines if this approach increases live birth rates, improves quality of life, and reduces feelings of depression. It suits those receiving prenatal care at WRNMMC who are early in pregnancy (up to 10 weeks) and have had at least two previous pregnancy losses. As an unphased trial, this study provides a unique opportunity to contribute to understanding supportive interventions in 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 prior data suggests that this messaging platform is safe for patients with recurrent pregnancy loss?

Research has shown that the tender loving care approach, which includes weekly supportive messages, is generally safe and well-received by patients who have experienced multiple miscarriages. Women who received this care in the past reported positive results without major side effects. Specifically, studies found that many women who received this support had successful pregnancies and experienced emotional improvement. This suggests that the approach is safe and may enhance pregnancy outcomes and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tender Loving Care intervention because it offers a unique approach to supporting women after a miscarriage. Unlike traditional treatments that primarily focus on physical recovery, this intervention provides emotional and psychological support through weekly prenatal counseling messages sent via an online platform. This method leverages digital technology to deliver consistent, personalized support, which can be more accessible and less stigmatizing than in-person therapy sessions. By focusing on emotional well-being, this intervention aims to address a critical gap in care and improve overall recovery outcomes for women experiencing miscarriage.

What evidence suggests that the Tender Loving Care Intervention is effective for improving pregnancy outcomes in patients with recurrent pregnancy loss?

Studies have shown that tender loving care (TLC) interventions can help women who have experienced multiple pregnancy losses. In this trial, participants will receive weekly prenatal counseling messages via an online platform as part of the TLC intervention. Women in previous studies who received regular, supportive messages reported feeling better and less depressed. This approach focuses on providing emotional support, which researchers believe positively affects pregnancy outcomes. Although data specifically linking TLC messaging to higher live birth rates is limited, the emotional and mental health benefits are well-documented. These benefits could significantly improve the overall pregnancy experience for those who have faced recurrent losses. ^{1 3 5 6 7}

Who Is on the Research Team?

David Boedeker, DO

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Unable to speak or understand English

Current smoker or tobacco use within 30 days

Suspicion for or confirmation of an ectopic pregnancy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tender Loving Care Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Tender loving care intervention Experimental Treatment 1 Intervention

Weekly prenatal counseling messages sent via an online platform.

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Published Research Related to This Trial

Women with recurrent miscarriages (RMs) strongly prefer a supportive care plan that includes a single, empathetic doctor who understands their history and provides regular ultrasounds during early pregnancy, with a median preference score of 8.0 out of 10.

Ethnicity and current pregnancy status significantly influence the level of supportive care women desire, with those from ethnic minorities and those not currently pregnant expressing a greater need for tailored supportive care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care for women with recurrent miscarriage: a survey to quantify women's preferences. Musters, AM., Koot, YE., van den Boogaard, NM., et al.[2022]

A consensus has been reached on essential investigations and treatments for women with recurrent miscarriages, including tests for lupus anticoagulant and thyroid function, and treatments like progesterone and aspirin combined with heparin.

Healthcare providers are encouraged to individualize care and ensure that these recommended investigations and treatments are universally available, while also addressing mental health and future obstetric risks for affected couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent miscarriage: evidence to accelerate action. Coomarasamy, A., Dhillon-Smith, RK., Papadopoulou, A., et al.[2022]

Couples experiencing recurrent pregnancy loss (RPL) expressed a strong need for more information, earlier access to treatment, and support that acknowledges the psychological impact of their losses, emphasizing the importance of including both partners in the care process.

The study revealed that both men and women felt pressure and exhaustion from multiple losses, highlighting the need for medical professionals to adopt a holistic, couple-focused approach that addresses both physical and psychological aspects of RPL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent pregnancy loss: couples' perspectives on their need for treatment, support and follow up. Koert, E., Malling, GMH., Sylvest, R., et al.[2020]

A study involving in-depth interviews with 15 women experiencing unexplained recurrent miscarriage revealed that they preferred supportive care options such as early and frequent ultrasounds, βHCG monitoring, and emotional support through counseling during their next pregnancy.

The findings highlight the importance of patient-centered care, as many of the preferred supportive care options can be provided by gynecologists to enhance the experience and reassurance for women facing recurrent miscarriage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care for women with unexplained recurrent miscarriage: patients' perspectives. Musters, AM., Taminiau-Bloem, EF., van den Boogaard, E., et al.[2022]

A survey of 139 participants, mostly women aged 35-44, revealed that 24% rated their recurrent miscarriage (RM) care experience as poor, highlighting significant dissatisfaction with the current care practices.

Key factors that improved care experiences included having a healthcare professional to discuss concerns, receiving a clear treatment plan, and getting understandable answers during subsequent pregnancies, indicating that better communication and support could enhance RM care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that shape recurrent miscarriage care experiences: findings from a national survey. Flannery, C., Hennessy, M., Dennehy, R., et al.[2023]

A study involving 574 hospitalized patients found that nursing interventions focused on exercise promotion, positioning, and self-care assistance significantly improved patients' functional health outcomes.

Improved functional status at discharge was linked to better therapeutic self-care ability, highlighting the importance of nursing interventions in enhancing patient recovery during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between nursing interventions and outcome achievement in acute care settings. Doran, D., Harrison, MB., Laschinger, H., et al.[2022]

In a study of 81 outpatients with wounds, the most common nursing intervention identified was 'Care with wounds,' which occurred in 47.23% of cases, highlighting the focus on wound management in nursing practice.

The primary outcome observed was 'Wound healing: secondary intention,' noted in 45% of cases, indicating that this is a key goal in the treatment of wounds and suggesting the need for updated nursing taxonomies to better reflect outpatient care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing interventions and outcomes classifications in patients with wounds: cross-mapping. Oliveira, FP., Oliveira, BG., Santana, RF., et al.[2017]

A total of 228 studies on patient outcomes in nursing were analyzed, revealing that 50% measured only a single outcome variable, with physical health and psychosocial functioning being the most common areas of focus.

There was significant variability in the measurement tools used across different nursing specialties, with only 20 out of 119 tools being used more than once, indicating a lack of standardization in patient-outcome measurement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

British studies which measure patient outcome, 1990-1994. French, B.[2019]

The Oncology Nursing Society (ONS) has developed resources focused on nursing-sensitive patient outcomes to enhance the quality of care for cancer patients and their families.

These resources, created in collaboration with researchers and nurses, provide evidence-based guidance for nursing interventions, which is essential for effective patient care and policy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing-sensitive patient outcomes: the development of the Putting Evidence into Practice resources for nursing practice. Gobel, BH., Beck, SL., O'Leary, C.[2019]

The study tested seven therapeutic nursing interventions on 50 chronically ill clients and found that these interventions significantly reduced feelings of powerlessness compared to a control group.

The research demonstrated that specific therapeutic nursing strategies are more effective in alleviating powerlessness than simply providing clients with decisional control options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring power through nursing intervention. Kubsch, S., Wichowski, HC.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06182878?draw=2&rank=1

Tender Loving Care for Recurrent Pregnancy Loss The goal of this investigational study is to evaluate participation in a weekly, interactive, tender loving care messaging platform impact on pregnancy outcomes ...

2. withpower.com withpower.com/trial/phase-fetal-death-2024-10343

Tender Loving Care for Miscarriage Trial Overview The study tests if a weekly tender loving care messaging platform can improve live birth rates, quality of life, and reduce depressive symptoms ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06182878/tender-loving-care-for-recurrent-pregnancy-loss

Tender Loving Care for Recurrent Pregnancy Loss The goal of this investigational study is to evaluate participation in a weekly, interactive, tender loving care messaging platform impact on pregnancy ...

4. elischolar.library.yale.edu elischolar.library.yale.edu/cgi/viewcontent.cgi?article=1065&context=ysmpa_theses

Tender Loving Care and the Woman with a History of ... 1-3,58,60-62 Pregnancy outcome at 12 weeks is a reasonable outcome, however, as most pregnancy losses in prior studies occurred during the ...

5. wmmjournal.org wmmjournal.org/index.php/wmm/article/view/97

Tender Loving Care: A Conceptual Analysis Background: Studies have shown that combining tender loving care (TLC) with the treatment of patients with recurrent miscarriages can ...

6. britishjournalofmidwifery.com britishjournalofmidwifery.com/content/research/tender-loving-care-following-recurrent-miscarriages-a-review-of-a-dedicated-antenatal-clinic/

Tender loving care following recurrent miscarriages Pregnancy outcomes for women attending the clinic were good; 69.2% of women went on to have a live birth. Conclusions. Pregnancy outcomes ...

7. withpower.com withpower.com/clinical-trials/for-miscarriage

Top Miscarriage Clinical Trials | Power The goal of this investigational study is to evaluate participation in a weekly, interactive, tender loving care messaging platform impact on pregnancy outcomes ...