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Behavioral Intervention
Tender Loving Care for Miscarriage
N/A
Recruiting
Led By David Boedeker, DO
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Age less than 18 years and older than 44 at time of enrollment
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if receiving weekly, supportive messages through a tender loving care platform can improve pregnancy outcomes for patients who have experienced recurrent pregnancy loss. It will investigate if these messages can increase live birth
Who is the study for?
This trial is for pregnant individuals who are less than 10 weeks along, have had at least two prior pregnancy losses confirmed by medical records or ultrasound, and can speak English. They must be getting prenatal care at WRNMMC.
What is being tested?
The study tests if a weekly tender loving care messaging platform can improve live birth rates, quality of life, and reduce depressive symptoms in patients with recurrent pregnancy loss. Participants will receive prenatal counseling and support through messages.
What are the potential side effects?
Since the intervention involves receiving supportive messages rather than medication or surgery, there are no direct physical side effects expected from this trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am between 18 and 44 years old.
Select...
I have a history of reproductive or immune system health issues.
Select...
I have had treatments that could affect my reproductive organs or a cancer in my reproductive system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Live birth rates
Secondary study objectives
Depressive symptoms
Fertility quality of life survey scores
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tender loving care interventionExperimental Treatment1 Intervention
Weekly prenatal counseling messages sent via an online platform.
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Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
143 Previous Clinical Trials
33,344 Total Patients Enrolled
David Boedeker, DOPrincipal InvestigatorWalter Reed National Military Medical Center