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Organisation of Early Pregnancy Units and its effects on quality of care

Variations in the organisation of Early Pregnancy Assessment Units (EPAUs) in the UK and their effects on clinical, service and patient-centred outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN10728897
Enrollment
6600
Registered
2016-07-05
Start date
2016-09-01
Completion date
Unknown
Last updated
2021-02-08

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

Conditions

Early pregnancy Pregnancy and Childbirth

Interventions

We propose to collect information about all women who present to a sample of EPAUs, with suspected complications of early pregnancy, for initial or follow-up visits. The main outcome

Sponsors

University College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Prospective observational cohort study (primary): Pregnant women (16 years of age and over) attending Early Pregnancy Assessment Units because of suspected early pregnancy complications. Health economic evaluation, patient satisfaction survey and qualitative interviews with service users: Pregnant women (16 years of age and over) attending Early Pregnancy Assessment Units because of suspected early pregnancy complications who agree to sign a written consent to participate. Hospital emergency care audit: All women attending hospital emergency service because of early pregnancy complications over a period of three months. Staff survey: All members of staff directly involved in providing early pregnancy care.

Exclusion criteria

Exclusion criteria: Health economic evaluation, patient satisfaction survey and qualitative study: Women who are haemodynamically unstable, in severe pain and those who refuse consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
Emergency hospital admissions as a proportion of women attending Early Pregnancy Units

Secondary

MeasureTime frame
1. Ratio of new to follow-up visits 2. Proportion of non-diagnostic ultrasound scans (pregnancy of unknown location) 3. Total number of emergency admissions of women presenting with early pregnancy complications 4. Proportion of laparoscopies negative for ectopic pregnancy 5. Ruptured ectopic pregnancies requiring blood transfusion 6. Estimated blood loss at operation 7. Patient satisfaction with the quality of care received 8. Staff experience of providing care 9. Proportion of women diagnosed with miscarriage treated surgically/medically/expectantly 10. Proportion of women diagnosed with ectopic pregnancy treated surgically/medically/expectantly 11. Visits to A&E departments 12. Admissions to ITU 13. Duration of admissions 14. Waiting times from referral to assessment 15. Quality of Life measures before and after assessment of women at the EPAU during initial and follow-up visits 16. Anxiety measured on a horizontal 10cm visual analog scale 17. Cost-effectiveness of different staffing models

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026