PreTerm RNA in Maternal Serum

Preterm Birth Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02521337
• Other study ID #: Pre Term MiRNA-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2015
• Last updated: December 18, 2016
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2016
• Source: Hadassah Medical Organization
• Contact: Drorith Hochner-Celnikier, MD
• Phone: 00 972 2 5484400
• Email: Hochner[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• observation
observation

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women with preterm labor that present a unique RNA cluster		2 years	No