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Antenatal screening for haemoglobinopathies in primary care: a cluster randomised trial to inform a simulation model

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN00677850
Enrollment
1320
Registered
2004-04-30
Start date
2004-10-01
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

Sickle cell and thalassaemia Haematological Disorders Sickle-cell disorders

Interventions

Please note that the anticipated end date of this trial has been extended to 30 April 2008 as of 14 December 2007 (Anticipated end date provided at time of registration: 30 September 2007). Closed to
(i.e. partners of women are only offered screening if the pregnant woman is found to be a carrier) Group 3: In community-based secondary care, when women are booked by midwives with sequential partner

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Eligible pregnant women receiving antenatal care at participating general practices 2. Aged 18 and over 3. Wanting to continue with the pregnancy 4. Carrier status is not documented in primary care records

Exclusion criteria

Exclusion criteria: 1. Women who do not want to continue with the pregnancies 2. Women who are more than 18 weeks gestation when reporting their pregnancies

Design outcomes

Primary

MeasureTime frame
1. Time in pregnancy of offer of carrier screening for sickle cell and thalassaemia 2. Time in pregnancy of testing for carrier status for sickle cell and thalassaemia

Secondary

MeasureTime frame
1. Rates of informed choice about undergoing the screening test 2. Time in pregnancy when women know the carrier status of the baby?s father 3. Couples emotional responses to carrier testing after they have received their test result

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026