Visit 1 (Routine control 2 term)a | Inform Visit | Visit 0 basal (20 weeks + 1 to 23 weeks + 6) | Visit 1 (V0 + 4 weeks) | Visit 2 (V1 + 4 weeks) | Visit 3 (V2 + 4 weeks) | Visit 4 (EOT) (37 weeks to 37 weeks + 4) | Post-delivery visit (4 to 6 weeks post-delivery) | |
---|---|---|---|---|---|---|---|---|
Eligibility criteria | √ | √ | ||||||
Informed consent | √ | |||||||
Randomization and start of treatment | √ | |||||||
Blood pressure/ weight | √ | √ | √ | √ | √ | |||
Vaginal culture | √ | |||||||
Manual vaginal exam | √ | √ | ||||||
Cervicometry | √ | √ | √ | √ | √ | √ | ||
Follow-up Questionnaire | √ | √ | √ | √ | ||||
Basic fetal US | √ | √ | √ | √ | ||||
End of treatment (EOT) | √ | |||||||
Review maternal medical history | √ | √ | ||||||
Review neonate medical history | √ |