Last updated: April 29, 2024
Sponsor: Walter Reed National Military Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Recurrent Pregnancy Loss
Treatment
Tender loving care intervention
Clinical Study ID
NCT06182878
23-17302
Ages 18-44 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 datingultrasound at the time of enrollment
- At least two prior pregnancy losses. Pregnancy losses must be confirmed withlaboratory criteria confirming a positive pregnancy test in the military electronicmedical record with subsequent resolution (resolution may be reported by patient), orwith ultrasound criteria demonstrating an intrauterine gestational sac with subsequentresolution (resolution may be reported by patient).
Exclusion
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
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Tender loving care intervention
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 01, 2025
Study Description
Connect with a study center
Walter Reed National Military Medical Center
Bethesda, Maryland 20814
United StatesActive - Recruiting
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