Clinical trial NCT06182878: Tender Loving Care for Recurrent Pregnancy Loss
Official title: A Single-arm Trial of a Web Based TLC (Tender Loving Care) Platform to Psychologically Support Patients With Recurrent Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Pregnancy Loss
Keywords: Recurrent Pregnancy Loss
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2023-12-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Live birth rates
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Fertility quality of life survey scores
timeFrame: Baseline at enrollment of study, repeat assessments at 13 weeks, 28 weeks, and 6 weeks after delivery or after miscarriage
measure: Depressive symptoms
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: David Boedeker, DO
role: PRINCIPAL_INVESTIGATOR
References: