Randomised Trial into Prevention of Preterm Birth: Feasibility Study
Research type
Research Study
Full title
Three-arm randomised trial of cervical cerclage, arabin pessary and vaginal progesterone to prevent spontaneous preterm birth in asymptomatic women at high-risk of preterm birth: a feasibility study
IRAS ID
156783
Contact name
Angharad Care
Contact email
Eudract number
2014-003112-36
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
Preterm birth (birth <37 weeks of pregnancy) is the leading cause of illness and death of newborn babies. The earlier babies are born, the more likely they are to die or develop long term complications of brain, lung and gut development – particularly those born before 32weeks.
Prematurity is a huge emotional burden for families and communities, and a financial burden costing the public sector an extra £2.95 billion annually. Two-thirds of preterm births (PTB) are spontaneous and we are not clear why they occur. We know that women who have previously had a PTB or have significant tissue removed from their cervix (neck of womb) are at higher risk than the background population. The risk is again increased if women are found to have a short cervix in pregnancy. This is identified by scanning (vaginally) and treatment can be offered to attempt to prolong pregnancy. There are currently three available treatments; Arabin pessary (silicone cup inserted vaginally to support the pregnancy), a cervical cerclage (stitch placed surgically into the cervix under regional anaesthetic) or vaginal progesterone pessaries (vaginal tablet, self-administered by the patient every night). We don’t know which works best. This makes decisions for doctors and already anxious patients very difficult.
A multicentre trial recruiting several hundred women from preterm labour clinics nationally and / or internationally will be needed to compare effectiveness of these treatments. This is expensive and requires meticulous planning to obtain good quality data and value for money. Our feasibility study will provide data to assess if this larger study can be performed.
This study will determine how many patients we can expect to recruit over a year, women's views and preferences to treatments and if our methods of randomising, data collection and economic analysis are achievable to inform an efficient definitive trial design.REC name
North West - Preston Research Ethics Committee
REC reference
14/NW/1392
Date of REC Opinion
17 Nov 2014
REC opinion
Further Information Favourable Opinion