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RECAP

Three-arm RandomisEd trial of cervical Cerclage, Arabin pessary, and vaginal Progesterone to prevent spontaneous preterm birth in asymptomatic high-risk

RECAP

Three-arm RandomisEd trial of cervical Cerclage, Arabin pessary, and vaginal Progesterone to prevent spontaneous preterm birth in asymptomatic high-risk
Funding NIHR RfPB
Portfolio Paediatric, foetal and maternal health
Interventions Other
Randomised Yes
Status Closed
Start Date 06-Oct-2015

Preterm birth (birth before 37 weeks of pregnancy) is the leading cause of
illness and death of newborn babies2. The earlier babies are born, the
more likely they are to die or develop long term complications of their 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 annually3.
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
risk. This risk is again increased if women are found to have a short cervix
in pregnancy4. 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 a
possible 22 preterm labour clinics nationally 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.

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