Tender Loving Care for Miscarriage

Recruiting in Palo Alto (17 mi)

Overseen by David Boedeker, DO

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

David Boedeker, DO

Principal Investigator

Walter Reed National Military Medical Center

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

Exclusion Criteria

Unable to speak or understand English

Current smoker or tobacco use within 30 days

Suspicion for or confirmation of an ectopic pregnancy

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 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.

Participant Groups

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+

Melissa C. Austin

Walter Reed National Military Medical Center

Chief Executive Officer since 2020

MD from University of Colorado Health Sciences Center

Melissa C. Austin

Walter Reed National Military Medical Center

Chief Medical Officer since 2020

MD, Board Certified in Anatomic and Clinical Pathology

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Relationship between nursing interventions and outcome achievement in acute care settings. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Nursing interventions and outcomes classifications in patients with wounds: cross-mapping. [2017]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Nursing-sensitive patient outcomes: the development of the Putting Evidence into Practice resources for nursing practice. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Restoring power through nursing intervention. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Supportive care for women with recurrent miscarriage: a survey to quantify women's preferences. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Recurrent miscarriage: evidence to accelerate action. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Recurrent pregnancy loss: couples' perspectives on their need for treatment, support and follow up. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Supportive care for women with unexplained recurrent miscarriage: patients' perspectives. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Factors that shape recurrent miscarriage care experiences: findings from a national survey. [2023]