Tender Loving Care for Recurrent Pregnancy Loss

Walter Reed National Military Medical Center

Status: Enrolling

Conditions: Recurrent Pregnancy Loss

Treatments: Behavioral: Tender loving care intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06182878

23-17302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Tender loving care intervention

Experimental group

Description:

Weekly prenatal counseling messages sent via an online platform.

Treatment:

Behavioral: Tender loving care intervention