Prevention of preterm birth
| ISRCTN | ISRCTN11186205 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11186205 |
| EudraCT/CTIS number | 2014-003112-36 |
| Secondary identifying numbers | 18675 |
- 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
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
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
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
| Study design | Three-arm multi-centre randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 06/10/2015 |
| Completion date | 31/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 39; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
1st floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Sponsor information
Hospital/treatment centre
Department of Pharmacology and Therapeutics
Liverpool
L69 3BX
England
United Kingdom
"ROR" |
https://ror.org/04xs57h96 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
18/10/2017: Internal review.
14/06/2016: Plain English summary added.
