Condition category
Pregnancy and Childbirth
Date applied
09/03/2016
Date assigned
10/03/2016
Last edited
14/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Department of Pharmacology and Therapeutics
Liverpool
L69 3BX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

14/06/2016: Plain English summary added.