Large scale genome sequencing and integrative analyses to define genomic predictors of recurrent pregnancy loss (GPRPL)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Observational
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
Unspecified
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Clinical Trials Website Interest FormBrief Summary
The overall goals of this proposal are to determine the genetic architecture of recurrent pregnancy loss (RPL) and to discover genomic predictors of RPL.
Eligibility
Cohort A - Fetal Intolerome Cohort
Inclusion Criteria:
- Women with loss of a current singleton pregnancy at < 20 0/7 weeks gestation, documented by ultrasonography or histopathological examination
- History of one or more prior pregnancy losses
- Euploid current pregnancy confirmed by karyotype, microarray, or STORK (Short-read Transpore Rapid Karyotyping) sequencing Note: A limited number of aneuploid losses will be included as part of the pilot phase
Exclusion Criteria:
- History of parental karyotype abnormalities
- History of antiphospholipid antibody syndrome
- Evidence of uncontrolled diabetes
- Evidence of uncontrolled thyroid disease
- History of autoimmune disease related to pregnancy loss (e.g., systemic lupus erythematosus, rheumatoid arthritis)
- History of uterine anomalies
- History of cervical insufficiency
Cohort B - Maternal Effect Gene Cohort
Inclusion Criteria:
- Women with a history of three or more pregnancy losses of unknown cause, with or without a liveborn child
Exclusion Criteria:
- Known etiology for pregnancy loss