Prevention of preterm birth

ISRCTN	ISRCTN11186205
DOI	https://doi.org/10.1186/ISRCTN11186205
Clinical Trials Information System (CTIS)	2014-003112-36
Protocol serial number	18675
Sponsor	University of Liverpool (UK)
Funder	National Institute for Health Research

Submission date: 09/03/2016
Registration date: 10/03/2016
Last edited: 18/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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)

Contact information

Dr Christine Cornforth
Scientific

Cancer Research UK Liverpool Cancer Trials Unit
University of Liverpool
1st Floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Mrs Ediri O'Brien
Public

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

Study information

Primary study design	Interventional
Study design	Three-arm multi-centre randomised parallel trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
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
Study objectives	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(s)	14/NW/1392
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Feasibility is measured at 12 months post recruitment, with follow up until final mother and baby discharge or 6 weeks postnatal.
Key secondary outcome measure(s)	1. Economic analysis is completed at 12 months post recruitment 2. Patient and staff acceptability is measured 1-2 months post study completion
Completion date	31/08/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	39
Key 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
Key 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)
Date of first enrolment	06/10/2015
Date of final enrolment	31/08/2017

Locations

Countries of recruitment

United Kingdom
England

Study 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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/10/2017: Internal review.
14/06/2016: Plain English summary added.