Tender Loving Care for Recurrent Pregnancy Loss

Recurrent Pregnancy Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182878
• Other study ID #: 23-17302
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Walter Reed National Military Medical Center
• Contact: David Boedeker, DO
• Phone: 301-400-2140
• Email: david.h.boedeker.mil[@]health.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Recurrence
• Recurrent Pregnancy Loss

Intervention

Behavioral:
• Tender loving care intervention
Receiving weekly prenatal care counseling messages

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rates	Live birth is defined as the delivery of at least one live-born infant at or after 22+0 weeks gestational age	through study completion, an average of 1 year
Secondary	Fertility quality of life survey scores	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.	Baseline at enrollment of study, repeat assessments at 13 weeks, 28 weeks, and 6 weeks after delivery or after miscarriage
Secondary	Depressive symptoms	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.	through study completion, an average of 1 year