Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-01-01
2025-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tender loving care intervention
Weekly prenatal counseling messages sent via an online platform.
Tender loving care intervention
Receiving weekly prenatal care counseling messages
Interventions
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Tender loving care intervention
Receiving weekly prenatal care counseling messages
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
44 Years
FEMALE
Yes
Sponsors
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Walter Reed National Military Medical Center
FED
Responsible Party
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Principal Investigators
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David Boedeker, DO
Role: PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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David Boedeker
Role: primary
Other Identifiers
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23-17302
Identifier Type: -
Identifier Source: org_study_id
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