Pregnancy Pregnancy and Childbirth
Conditions
Interventions
Phase one: an observational cohort study (n=30) using anxiety diaries and qualitative interviews. Phase two: a 2 X 2 factorial design randomised controlled trial. Participants will be randomised immed
Sponsors
Department of Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pregnant women who are having an amniocentesis for indications such as maternal age, triple test risk or the presence of a soft marker for Downs Syndrome
Exclusion criteria
Exclusion criteria: Women with a major structural abnormality on scan. Women who miscarry before the karyotype result is obtained (<1%) or whose result indicates aneuploidy (1 in 70) will be excluded from the primary analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will measure anxiety daily using the short Spielberger state measure with regular phone reminders The primary outcomes will be total anxiety in the first 24 hours after the test, over the last 24 hours before the result is issued, and the peak level of anxiety reached. Within 24 hours of issuing the results, parents will be asked to recall and score their anxiety over the waiting period. This will provide validation of the prospectively collected scores. We will not conduct any economic analysis because the costs of different modes of issuing results will be similar and the leaflets will be cheap. We will recommend that the method, which minimises anxiety, be used. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed