PROGRAM
Research type
Research Study
Full title
A randomised controlled feasibility study of the tolerability of the combination of PROGesteRone and AMinophylline for the prevention of preterm labour (PROGRAM)
IRAS ID
160005
Contact name
Professor Mark R Johnson
Contact email
Sponsor organisation
Imperial College London
Eudract number
2016-002087-14
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Preterm birth is the leading cause of neonatal mortality in both the UK and United States. Preterm labour (PTL) precedes approximately 66% of preterm births. A recent systematic review has estimated that 15 million births per annum, or 9.6% of all births worldwide, were preterm. The Epicure study showed that survival of babies born between 22 and 25 weeks gestation has increased, but the proportion of survivors with major morbidity is unchanged. These data suggest that the total number of children in the community with lifelong health problems attributable to extremely preterm birth is rising.
Two recent observations have changed the management of spontaneous preterm labour (sPTL). The first that 60% of women at risk of early (before 30 weeks) prematurity and 80% of women at risk of extreme (before 28 weeks) prematurity due to sPTL can be identified at 23 weeks by a combination of transvaginal cervical length assessment and elements of the obstetric history (7) and the second, that progesterone (P4) administration reduces the risk of sPTL in high-risk women. Further, Hassan et al showed in the largest multicentre randomized double-blind trial that P4 was also associated with a 61% reduction in the risk of respiratory distress syndrome. However, P4 only reduces the risk of PTL by about 40% in high-risk singleton pregnancies and has no effect in multiple pregnancy, meaning that other more effective alternative therapeutic options need to be explored.
The aim of this study is to investigate whether the combination of aminophylline and P4 is acceptable to women at high-risk of PTL. If this proves to be the case we will then perform a larger double blind, RCT to test the hypothesis that the combination of P4 and aminophylline reduces the risk of PTL more effectively than P4 alone.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0299
Date of REC Opinion
5 Dec 2016
REC opinion
Further Information Favourable Opinion