PreTerm RNA in Maternal Serum

• Conditions: Preterm Birth
• Interventions: Other: observation

• Registration Number: NCT02521337
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-08-09
• Study First Posted: 2015-08-13
• Study Start: 2016-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-18
• Last Update Posted: 2016-12-20
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

Exclusion criteria will include:

1. multiple gestation,
2. major fetal anomalies,
3. IUFD,
4. severe preeclampsia,
5. chronic steroid or immunosuppressive drug use,
6. active immunological illness,
7. and/or pregestational and gestational DM.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant women not in active labor	observation	-
pregnant women in preterm labor	observation	-
pregnant women in term labor	observation	-

Primary Outcome Measures

Name	Time	Method
Number of women with preterm labor that present a unique RNA cluster	2 years

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel