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Clinical Trials/NCT02521337
NCT02521337
Unknown
Not Applicable

PreTerm RNA in Maternal Serum

Hadassah Medical Organization1 site in 1 country150 target enrollmentJanuary 2016
ConditionsPreterm Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Hadassah Medical Organization
Enrollment
150
Locations
1
Primary Endpoint
Number of women with preterm labor that present a unique RNA cluster
Last Updated
9 years ago

Overview

Brief Summary

Preterm birth is defined as a birth occurring before the completion of 37 weeks gestation. The incidence of preterm birth in Israel in the last years is around 7-8%.

Despite various diagnostic modalities as well as newly therapeutic approaches the incidence of preterm birth remains unchanged and is considered to be the leading cause of neonatal morbidity and mortality.

In the last decade, small RNAs have emerged as an important player in both physiological and pathophysiological responses. These single strands, non-coding regulatory RNA molecules are responsible for post transcriptional regulation of target genes. Hence, may provide a new opportunity for biomarkers discovery in the field of preterm birth.

The main objective of this study is to identify a distinctive expression profile of maternal circulating RNAs that will be used as biomarkers for preterm birth.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 2018
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women with singleton pregnancy at 26-32 week of gestation with no clinical symptoms of preterm labor.
  • Women with singleton pregnancy 24-34 week of gestation who present to the labor suite with symptoms suspected for preterm labor.
  • Women with singleton pregnancy in term active labor (weeks 37-40).

Exclusion Criteria

  • Exclusion criteria will include:
  • multiple gestation,
  • major fetal anomalies,
  • severe preeclampsia,
  • chronic steroid or immunosuppressive drug use,
  • active immunological illness,
  • and/or pregestational and gestational DM.

Outcomes

Primary Outcomes

Number of women with preterm labor that present a unique RNA cluster

Time Frame: 2 years

Study Sites (1)

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