RECRUITING

Tender Loving Care for Recurrent Pregnancy Loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-01

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06182878

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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).	* 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

Inclusion Criteria

Exclusion 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).

* 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

Contacts and Locations

Study Contact

David Boedeker, DO

CONTACT

301-400-2140

david.h.boedeker.mil@health.mil

Kiley Hunkler, MD

CONTACT

301-400-2140

kiley.f.hunkler.mil@health.mil

Principal Investigator

David Boedeker, DO

PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Study Locations (Sites)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814

United States

Collaborators and Investigators

Sponsor: Walter Reed National Military Medical Center

David Boedeker, DO, PRINCIPAL_INVESTIGATOR, Walter Reed National Military Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

Recurrent Pregnancy Loss

Additional Relevant MeSH Terms

Recurrent Pregnancy Loss