Recurrent Pregnancy Loss
Conditions
Keywords
Recurrent Pregnancy Loss
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.
Interventions
BEHAVIORALTender loving care intervention
Receiving weekly prenatal care counseling messages
Sponsors
Walter Reed National Military Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rates | through study completion, an average of 1 year | Live birth is defined as the delivery of at least one live-born infant at or after 22+0 weeks gestational age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fertility quality of life survey scores | Baseline at enrollment of study, repeat assessments at 13 weeks, 28 weeks, and 6 weeks after delivery or after miscarriage | 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. |
| Depressive symptoms | through study completion, an average of 1 year | 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. |
Countries
United States
Contacts
CONTACTDavid Boedeker, DO
CONTACTKiley Hunkler, MD
PRINCIPAL_INVESTIGATORDavid Boedeker, DO
Walter Reed National Military Medical Center
Outcome results
None listed