Tender Loving Care for Recurrent Pregnancy Loss

Last updated: April 29, 2024
Sponsor: Walter Reed National Military Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Recurrent Pregnancy Loss

Treatment

Tender loving care intervention

Clinical Study ID

NCT06182878
23-17302
  • Ages 18-44
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 datingultrasound at the time of enrollment
  • At least two prior pregnancy losses. Pregnancy losses must be confirmed withlaboratory criteria confirming a positive pregnancy test in the military electronicmedical record with subsequent resolution (resolution may be reported by patient), orwith ultrasound criteria demonstrating an intrauterine gestational sac with subsequentresolution (resolution may be reported by patient).

Exclusion

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

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Tender loving care intervention
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 01, 2025

Study Description

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.

Connect with a study center

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20814
    United States

    Active - Recruiting

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