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A feasibility study and pilot randomised trial of an intervention designed to reduce unnecessary caesarean section in Ireland

Reducing caesarean section rates in Ireland: a feasibility study and pilot randomised trial of an evidence-based intervention designed to reduce caesarean section safely

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50041378
Enrollment
800
Registered
2018-02-25
Start date
2018-03-01
Completion date
Unknown
Last updated
2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour and delivery Pregnancy and Childbirth Caesarean section

Interventions

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 de

Sponsors

Health Research Board
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Vaginal birth contraindicated at time of booking

Design outcomes

Primary

MeasureTime frame
Caesarean section rate (overall per site) is measured using hospital birth records

Secondary

MeasureTime frame
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).

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026