Interactive support messaging for women with recurrent pregnancy loss
A Single-arm Trial of a Web Based TLC (Tender Loving Care) Platform to Psychologically Support Patients With Recurrent Pregnancy Loss
This study tests if a weekly messaging program that offers support and advice can help women who have had multiple pregnancy losses have healthier pregnancies and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06182878 on ClinicalTrials.gov |
What this trial studies
This investigational study evaluates the impact of a weekly interactive messaging platform designed to provide tender loving care on pregnancy outcomes for individuals experiencing recurrent pregnancy loss. Participants will engage with messages that offer prenatal counseling and support while completing a fertility quality of life survey throughout their pregnancy. The study aims to determine if this intervention can increase live birth rates, enhance quality of life, and reduce depressive symptoms among participants.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals at less than or equal to 10 weeks gestation with a history of at least two prior pregnancy losses.
Not a fit: Patients with certain medical conditions, such as uterine anomalies or those who are current smokers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve live birth rates and overall well-being for patients with recurrent pregnancy loss.
How similar studies have performed: While the specific approach of interactive messaging for this condition is novel, similar supportive interventions have shown promise in improving outcomes in other patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant individuals receiving their prenatal care at WRNMMC * Able to speak and understand English * Less than or equal to 10+0 weeks gestation by last menstrual period (LMP) or dating ultrasound at the time of enrollment * At least two prior pregnancy losses. Pregnancy losses must be confirmed with laboratory criteria confirming a positive pregnancy test in the military electronic medical record with subsequent resolution (resolution may be reported by patient), or with ultrasound criteria demonstrating an intrauterine gestational sac with subsequent resolution (resolution may be reported by patient). Exclusion Criteria: * Age less than 18 years and older than 44 at time of enrollment * Unable to speak or understand English * Current smoker or tobacco use within 30 days * History of uterine anomaly, coagulopathy, balanced translocation, endometrial polyps, submucosal fibroids, pathology confirmed acute or chronic endometritis, hydrosalpinx, history of Asherman syndrome, poorly controlled endocrinopathies, HIV infection * History of gonadotoxic therapy or cancerous condition of the female reproductive tract * Suspicion for or confirmation of an ectopic pregnancy
Where this trial is running
Bethesda, Maryland
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: David Boedeker, DO — Walter Reed National Military Medical Center
- Study coordinator: David Boedeker, DO
- Email: david.h.boedeker.mil@health.mil
- Phone: 301-400-2140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.