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Recruiting

NCT Number: NCT06182878

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 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.

Recruiting

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location status: Recruiting

Location contact

David Boedeker

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tender loving care intervention

Behavioral

Receiving weekly prenatal care counseling messages

Primary outcomes

  1. Live birth rates

    Time frame: through study completion, an average of 1 year

    Live birth is defined as the delivery of at least one live-born infant at or after 22+0 weeks gestational age

Secondary outcomes

  1. Fertility quality of life survey scores

    Time frame: Baseline at enrollment of study, repeat assessments at 13 weeks, 28 weeks, and 6 weeks after delivery or after miscarriage

    Quality of life will be defined using the fertility quality of life scores. The survey is entitled, "Fertility quality of life questionnaire." Survey responses are based on a five-point scale, with responses such as "very good" and "very satisfied" corresponding to better outcomes.

  2. Depressive symptoms

    Time frame: through study completion, an average of 1 year

    Depressive symptoms will be defined using the survey entitled, "Edinburgh Postnatal Depression Scores." This survey uses a four-point scale for each response, with higher cumulative scores corresponding to worse outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

David Boedeker, DO

CONTACT

[email protected]

301-400-2140

Kiley Hunkler, MD

CONTACT

[email protected]

301-400-2140

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Registry information

Official study title

A Single-arm Trial of a Web Based TLC (Tender Loving Care) Platform to Psychologically Support Patients With Recurrent Pregnancy Loss

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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