Recruiting

Tender Loving Care

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT06182878

Conditions

Recurrent Pregnancy Loss

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

Tender loving care intervention

Study Details

Brief summary:

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.

Conditions

Recurrent Pregnancy Loss

Study ID

NCT06182878

Start date

Jan 1, 2024

Status verified date

Jul, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tender loving care intervention

Weekly prenatal counseling messages sent via an online platform.

Interventions

Tender loving care intervention

Receiving weekly prenatal care counseling messages

Primary outcome measure

  • Live birth rates [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

David Boedeker, DO

301-400-2140david.h.boedeker.mil@health.mil

Kiley Hunkler, MD

301-400-2140kiley.f.hunkler.mil@health.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20814

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Apr 22, 2026

Last verified

Jul, 2025

Keywords

  • Recurrent Pregnancy Loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2026-04-22.