Table 1 Design of the BE-UP Study
| Â | Time line | |||||||
|---|---|---|---|---|---|---|---|---|
| Â | Information, confirmation of eligibility, signed consent | Reconfirmation of eligibility, signed consent | Assessment of baseline data (t0) | Randomisation (when both intervention and control rooms are available) | Intervention/ control | Data assessment points | ||
Design of birthing room for women in labour (1st and 2nd stages of labour and birth) | In birthing room (t1) | Before dis-charge from hospital (t2) | 3Â months post-partum (t3) | |||||
Intervention group | Information materials, eligibility log with IC/EC First time: When booking the birth (34th–38th week of pregnancy) | Information materials, eligibility log with IC/EC Second time: On admission to the labour unit (prior to randomisation) | All eligible and consenting participants, prior to randomisation (unbiased) | iPad + WLAN stick for accessing external centrally controlled concealed online randomisation | Intervention birthing room: Special design (reconceptualised) |  |  |  |
From admission of woman to birthing room up to discharge to postnatal ward or home Emergency equipment available Labour support by midwives and obstetricians | ||||||||
Controlgroup | Information materials, eligibility log with IC/EC First time: When booking the birth (34th–38th week of pregnancy) | Information materials, eligibility log with IC/EC Second time: On admission to the labour unit (prior to randomisation) | All eligible and consenting participants, prior to randomisation (unbiased) | iPad + WLAN stick for accessing external centrally controlled concealed online randomisation | Control birthing room: Designed according to current practice |  |  |  |
From admission of woman to birthing room up to discharge to postnatal ward/home; emergency equipment available; labour support by midwives and obstetricians | ||||||||
Data | Check IC/EC | Check IC/EC | Collect psycho-social and obstetric data | Â | Process data on midwifery and obstetrical care | Assess primary, secondary and other endpoints | Assess experience of birth and breast-feeding and health economic variables | Assess maternal self-determination and health economic variables |