Early prediction of preterm birth (Version 1)
Research type
Research Study
Full title
Early prediction of preterm birth with maternal factors, cervical length and quantitative cervicovaginal fetal fibronectin.
IRAS ID
147570
Contact name
Leona Poon
Contact email
Sponsor organisation
King's College London
Research summary
Preterm delivery is the leading cause of perinatal death and handicap in children and the vast majority of mortality and morbidity relates to early delivery before 34 weeks. It is estimated that more than 1 million children in the world die every year because of preterm birth. Although improvements in neonatal care have led to higher survival of very premature infants, a major impact on the associated mortality and morbidity will only be achieved through the development of a sensitive method to identify women at high risk of preterm delivery and an effective strategy for the prevention of this complication.
The measurement of cervical length by trans-vaginal ultrasound scan at 20-24 weeks' gestation has been shown to be moderately effective in the prediction of spontaneous preterm birth.
Fetal fibronectin (fFN), which is a protein secreted from the decidua and chorion (membranes between the womb and afterbirth), is normally present in vaginal secretions before 21 weeks’ gestation. The presence of this protein in vaginal secretion between 24-34 weeks’ gestation has been associated with preterm birth. Current available evidence does not support the use of qualitative fFN (positive or negative result) as a screening test for low risk women. With the introduction of a quantitative fFN test, this study aims to explore if the addition of this testing to maternal risk factors, cervical length and blood biomarkers yields a significant improvement in the detection of spontaneous preterm birth.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1079
Date of REC Opinion
8 Sep 2014
REC opinion
Further Information Favourable Opinion