PreTerm RNA in Maternal Serum

Hadassah Medical Center

Status: Unknown

Conditions: Preterm Birth

Treatments: Other: observation

Study type: Observational

Funder types: Other

Identifiers

NCT02521337

Pre Term MiRNA-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

pregnant women not in active labor

Treatment:

Other: observation

pregnant women in preterm labor

Treatment:

Other: observation

pregnant women in term labor

Treatment:

Other: observation