Skip to content

An evaluation of the effectiveness of midwifery-led services in the health service executive - North Eastern area: the MidU Study - a randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14973283
Enrollment
1500
Registered
2007-09-07
Start date
2005-02-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Models of maternity care Pregnancy and Childbirth Maternity care

Interventions

In this study, the experimental group will receive the experimental intervention of midwifery-led care in a midwifery-led unit while the control group will receive standard care in a consultant-led un

Sponsors

Trinity College Dublin (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women are eligible for trial entry if they are: 1. Healthy with an absence of risk factors for complications for labour and delivery as identified in the ?Midwifery-led Unit (Integrated) Guidelines for Practitioners? 2. Aged between 16 and 40 years of age 3. Within 24 completed weeks of pregnancy

Exclusion criteria

Exclusion criteria: Women who do not meet the above criteria.

Design outcomes

Primary

MeasureTime frame
1. Rate of interventions 2. Maternal satisfaction 3. Neonatal and maternal morbidity outcomes All outcomes are measured in the postnatal period by review of records as and when such records become available.

Secondary

MeasureTime frame
1. Antenatal (measured postnatally): 1.1. Number of antenatal visits: midwife, GP and consultant 1.2. Number of prenatal ultrasound examinations 1.3. Tests of foetal well-being: non-stress test; biophysical profile 1.4. Antenatal transfer to consultant-led care 1.5. Antenatal admission 1.6. Pregnancy complications: pregnancy related hypertensive disorders; antepartum haemorrhage; gestational diabetes (insulin, non-insulin) 1.7. Foetal loss before 24 weeks: spontaneous and induced abortion 1.8. Foetal loss after 24 weeks: prior to labour 1.9. Induction of labour 1.10. Women's experiences of and satisfaction with antenatal care: measured by postnatal questionnaire 2. Labour (measured postnatally): 2.1. Labour onset: spontaneous; induced (prostaglandins, amniotomy, oxytocin, reason for induction); not in labour, caesarean section 2.2. Spontaneous rupture of membranes 2.3. Amniotomy 2.4. Acceleration during labour: amniotomy; oxytocin 2.5. Artificial oxytocin during labour (1st to 3rd stage) 2.6. Analgesia/anaesthesia: none; pharmacological (pethidine, nitrous oxide, pudendal block, spinal anaesthetic, general anaesthetic, local analgesia postpartum, epidural analgesia); non-pharmacological (Transcutaneous Electrical Nerve Stimulation [TENS], hydrotherapy) 2.7. Labour length (1st to 3rd stage) 2.8. Foetal heart rate monitoring: intermittent auscultation only; intermittent auscultation then continuous electronic Cardiotocography (CTG) (commenced with intermittent auscultation then reverted to continuous electronic CTG); admission CTG plus intermittent auscultation only; admission CTG plus intermittent electronic plus intermittent auscultation (admission CTG plus additional CTG at intervals with intermittent auscultation between CTG recordings); continuous electronic CTG (cardiotocography greater than 75% of time from admission to labour ward to delivery); foetal scalp/spiral electrode; foetal scalp blood sampling 2.9. Perceived control during labour: measured by the Lab

Countries

Ireland

Outcome results

None listed

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