Tender Loving Care for Recurrent Pregnancy Loss

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

Conditions
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Recurrent Pregnancy Loss

Intervention / Treatment
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* Behavioral: Tender loving care intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tender loving care intervention<br>Weekly prenatal counseling messages sent via an online platform. | Behavioral: Tender loving care intervention<br>* Receiving weekly prenatal care counseling messages<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Pregnancy Loss