Plain English Summary
Background and study aims
About 11% of all babies born worldwide are preterm (premature), meaning that they are born more than three weeks before their due date. 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 32 weeks. 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) happen spontaneously, the reason for which is unclear. Women who have previously had a PTB, have had important tissue removed from their cervix (neck of womb), or have a short cervix are more likely to give birth prematurely than the general population. There are currently three main treatments available which aim to help prolong pregnancy, preventing PTB: an arabin pessary, a cervical cerclage, or a vaginal progesterone pessary. It is currently not known which technique is the most effective. The aim of this study is to compare these treatments in a small study in order to find out whether it would be possible to later conduct a large-scale study.
Who can participate?
Women aged 18 and over who are between 16 and 24 weeks pregnant with a single baby, who are at risk of having a pre-term birth.
What does the study involve?
Participants are randomly allocated to receive one of three treatments: an arabin pessary (a silicone cup inserted vaginally to support the pregnancy), a cervical cerclage (a stitch placed surgically into the cervix), or a vaginal progesterone pessary (a vaginal tablet containing the hormone progesterone that is put in place by the patient every night). Patient and staff acceptability is measured 1-2 months after the end of the study, and the feasibility of recruiting participants for a large-scale study is assessed at 12 months after recruitment, along with an economic analysis.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
October 2015 to August 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Dr Christine Cornforth (scientific)
2. Mrs Ediri O’Brien (public)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Christine Cornforth
ORCID ID
Contact details
Cancer Research UK Liverpool Cancer Trials Unit
University of Liverpool
1st Floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Type
Public
Additional contact
Mrs Ediri O'Brien
ORCID ID
Contact details
Liverpool Cancer Trials Unit
Cancer Research UK Liverpool Cancer Trials Unit
University of Liverpool
1st floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Additional identifiers
EudraCT number
2014-003112-36
ClinicalTrials.gov number
Protocol/serial number
18675
Study information
Scientific 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
Acronym
Study hypothesis
The aim of this study is to explore the feasibility of recruiting participants for a large-scale clinical trial looking at different treatments designed to prevent preterm labour.
Ethics approval
14/NW/1392
Study design
Three-arm multi-centre randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Reproductive Health; Subtopic: Reproductive Health & Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth
Intervention
Participants are randomly allocated to receive one of three treatments:
1. Arabin pessary: silicone cerclage pessary device sited around cervix in clinic
2. Cervical cerclage: Macdonald technique to site suture, surgically in cervical tissue. Performed in theatre under aseptic technique
3. Vaginal progesterone: single administration vaginal micronised progesterone pessary (Uterogestan) 200mg nocte pv, prescription given in clinic and collected from pharmacy
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Feasibility is measured at 12 months post recruitment, with follow up until final mother and baby discharge or 6 weeks postnatal.
Secondary outcome measures
1. Economic analysis is completed at 12 months post recruitment
2. Patient and staff acceptability is measured 1-2 months post study completion
Overall trial start date
06/10/2015
Overall trial end date
31/08/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Singleton pregnancy
3. Between 16+0 – 24+6 weeks in current pregnancy
4. History of previous spontaneous preterm birth (sPTB) or premature rupture of membranes (PPROM) between 16-33+6
AND
5. Cervical length at least <3rd centile for gestational age
OR
6. History of significant cervical surgery defined as two large loop excision of the transformation zone (LLETZ) procedures or a single knife cone biopsy (KCB) where a clinical decision is made to treat the short cervix
7. Clinical equipoise as to what is the best treatment
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 39; UK Sample Size: 39
Participant exclusion criteria
1. Known or suspected structural or chromosomal fetal abnormality
2. Inability to give informed consent
3. Treatment with history indicated cerclage
4. Treatment with vaginal progesterone within two weeks of randomisation
5. All contraindications to use of progesterone (see protocol 6.2)
Recruitment start date
06/10/2015
Recruitment end date
31/08/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK Liverpool Cancer Trials Unit
University of Liverpool
1st floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary