A feasibility study and pilot randomised trial of an intervention designed to reduce unnecessary caesarean section in Ireland
| ISRCTN | ISRCTN50041378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50041378 |
| Secondary identifying numbers | DIFA-2017-011 |
- Submission date
- 12/02/2018
- Registration date
- 25/02/2018
- Last edited
- 15/05/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Concern has been expressed globally at the rising caesarean section (CS) rate, and this has not resulted in a decrease in health problems for mothers and babies, indicating that many CSs are not necessary. Death and severe health problems are increased (3-fold) for women following CS compared with vaginal birth, and more newborn babies require oxygen after CS. This study aims to develop and test a package of care that is designed to reduce overall CS rates in Ireland, safely.
Who can participate?
Pregnant women aged over 18 years
What does the study involve?
Participants giving birth at one site receive the intervention, and those at the other site receive standard care. All participants complete three health and wellbeing surveys, one in pregnancy, one at 3 months after their baby is born and a final survey 6 months after their baby is born. Hospital records are accessed to gather information on their pregnancy, labour and birth (all information is kept strictly private and confidential). Participants in the intervention hospital also attend two antenatal classes where information specific to CS birth is presented and discussed.
What are the possible benefits and risks of participating?
The main benefit is that participants are helping to answer whether the information package is effective or not in reducing caesarean section rates overall. If their hospital has been allocated to test the new programme, it is possible that participants may find the information beneficial. There are no known risks to taking part in this study.
Where is the study run from?
1. The Coombe Women and Infants University Hospital (Ireland)
2. The Rotunda Hospital (Ireland)
When is the study starting and how long is it expected to run for?
September 2017 to September 2020
Who is funding the study?
Health Research Board (Ireland)
Who is the main contact?
Prof Cecily Begley (Public)
cbegley@tcd.ie
Contact information
Scientific
School of Nursing and Midwifery
Trinity College Dublin
24 D'Olier Street
Dubliin
2
Ireland
 ORCID ID |
0000-0003-2249-6038 |
|---|---|
| Phone | +353 (0)1 896 4031 |
| smithv1@tcd.ie |
Study information
| Study design | Feasibility study and pilot cluster randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | ISRCTN50041378_PIS_V1_23Feb18.pdf |
| Scientific title | Reducing caesarean section rates in Ireland: a feasibility study and pilot randomised trial of an evidence-based intervention designed to reduce caesarean section safely |
| Study acronym | REDUCE |
| Study objectives | A complex package of care, based on evidence, can reduce overall caesarean section rates |
| Ethics approval(s) | 1. Faculty of Health Sciences, Research Ethics Committee Trinity College Dublin, 19/12/2017, ref: 170501 2. Rotunda Hospital Research Ethics Committee Dublin, 15/12/2017, ref: REC-2017-026 3. The Coombe Women and Infants Hospital Research Ethics Committee Dublin, 10/10/2017, ref: 21-2017 |
| Health condition(s) or problem(s) studied | Labour and delivery |
| Intervention | The study sites (n=2) are randomly allocated to the intervention or control by an independent statistician with no connection to the trial, using the R-software. The intervention is developed, as part of the overall trial, using focus group interviews (FGIs) (4 with 3-6 women and their partners, 4 with 3-6 clinicians) in the hospital allocated randomly to the intervention arm. The FGIs ascertain views on, and barriers to, facilitating vaginal birth (FGIs will not be held in the control site so as to avoid contamination of the population in advance of the trial) and an overview of systematic reviews on antenatal and intrapartum interventions to identify those interventions that have shown to be effective for reducing CS. Based on existing evidence, the intervention will likely consist of an appointment of an obstetric and midwife opinion leader (OOL, MOL) who will facilitate women-centred, evidence-based antenatal classes (2 classes) and information session for clinicians, providing accurate information on the risks and benefits of both VBAC and repeat CS, second opinions for all CSs (other than category 1), peer-review of each CS and feedback, reducing induction of labour rates, support of clinicians and women to choose normal options over medical intervention (e.g. mobility instead of oxytocin, water-bath instead of pharmacological pain relief, reducing use of EFM in low-risk women). The protocol will be updated in Aug 2018 when the intervention is finalised. Participants at the control site receive usual care as per current hospital practice. Participants at both sites are followed through pregnancy, up to 6 months postpartum. |
| Intervention type | Behavioural |
| Primary outcome measure | Caesarean section rate (overall per site) is measured using hospital birth records |
| Secondary outcome measures | 1. Labour interventions (e.g. induction and acceleration of labour, pain relief used, electronic fetal monitoring) are measured by reviewing women's hospital labour and birth records. 2. Maternal/neonatal morbidities (e.g. postpartum haemorrhage, perineal trauma, wound infection, need for neonatal resuscitation, neonatal admission to intensive care, readmission to hospital) are assessed using hospital records. 3. Mother and baby health problems are assessed using self-completion surveys (health and wellbeing questionnaires that include the SF-36 instrument) during pregnancy and at 3 and 6 months post natal. 4. Clinician attitudes to caesarean section are measured by a self-completion questionnaire adapted from the UK National Sentinel Caesarean Section Audit. 5. Feasibility and pilot outcomes (% eligible and participating, time to recruit, etc.) are assessed using trial screening and eligibility forms, numbers participating (consent forms) and time to recruit full sample size (months). |
| Overall study start date | 01/09/2017 |
| Completion date | 30/09/2020 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 2 clusters (400 participants in each cluster) |
| Key inclusion criteria | 1. Pregnant woman 2. Aged over 18 3. Speak either English or a language for which translation is available 4. Give informed consent |
| Key exclusion criteria | Vaginal birth contraindicated at time of booking |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 29/02/2020 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Dublin
8
Ireland
Dublin
1
Ireland
Sponsor information
Research organisation
Grattan House
67-72 Lower Mount Street
Dublin
D02 H638
Ireland
| Phone | +353 (0)1 2345000 |
|---|---|
| hrb@hrb.ie | |
| Website | http://www.hrb.ie/home/ |
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Open access peer reviewed Journals, conference presentations, research proceedings and maternity care representative and user Networks. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to a lack of ethical approval granting permission for this. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1 | 23/02/2018 | 01/04/2019 | No | Yes |
Additional files
- ISRCTN50041378_PIS_V1_23Feb18.pdf
- Uploaded 01/04/2019
Editorial Notes
15/05/2019: The study, in the original planned form of a pilot cluster randomised trial, has been stopped. This was because, in the first phase, a systematic review of 155 systematic reviews of studies where caesarean section was a primary or secondary outcome was conducted, which showed conclusively that although many interventions were known to decrease CS rates, they were not being implemented. A pilot implementation research study is therefore being conducted instead, which will test the feasibility and acceptability of an evidence-based intervention designed to reduce overall caesarean section rates in Ireland, using an implementation research approach.
01/04/2019: The participant information sheet has been uploaded.
