Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Valerie Smith
ORCID ID
http://orcid.org/0000-0003-2249-6038
Contact details
School of Nursing and Midwifery
Trinity College Dublin
24 D'Olier Street
Dubliin
2
Ireland
+353 (0)1 896 4031
smithv1@tcd.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DIFA-2017-011
Study information
Scientific title
Reducing caesarean section rates in Ireland: a feasibility study and pilot randomised trial of an evidence-based intervention designed to reduce unnecessary caesarean section
Acronym
REDUCE
Study hypothesis
A complex package of care, based on evidence, can reduce overall caesarean section rates
Ethics approval
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
Study design
Feasibility study and pilot cluster randomised trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/09/2017
Overall trial end date
30/09/2020
Reason abandoned
Eligibility
Participant 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
Participant type
Mixed
Age group
Adult
Gender
Female
Target number of participants
2 clusters (400 participants in each cluster)
Participant exclusion criteria
Vaginal birth contraindicated at time of booking
Recruitment start date
01/03/2018
Recruitment end date
29/02/2020
Locations
Countries of recruitment
Ireland
Trial participating centre
The Coombe Women and Infants University Hospital
Rialto
Dublin
8
Ireland
Trial participating centre
The Rotunda Hoapital
Parnell Strett
Dublin
1
Ireland
Sponsor information
Organisation
Health Research Board
Sponsor details
Grattan House
67-72 Lower Mount Street
Dublin
D02 H638
Ireland
+353 (0)1 2345000
hrb@hrb.ie
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Health Research Board (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Open access peer reviewed Journals, conference presentations, research proceedings and maternity care representative and user Networks.
IPD sharing statement:
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.
Intention to publish date
01/02/2021
Participant level data
Not expected to be available
Results - basic reporting
Publication summary