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Table 3 Data collection, instruments and assessment times

From: Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial

At randomization (T0)

Data on the health status of the participant and pregnancy characteristics will be collected from medical files of the practitioners. A face-to-face questionnaire will be also completed by all women and filled out by the midwife/obstetrician to collect specific data on demographics characteristics, smoking and alcohol habits, previous pregnancies and personal hygiene. The first vaginal swab will be collected by the practitioner and send to one of the two point-of-care laboratories associated to the study.

At baseline assessment – (during screening and treatment phases - T1)

Subsequent vaginal swabs will be realized during either routine pregnancy consultation or at the woman’s home depending on each participant schedule. In this later case, the sample will be sent by the women to the referent POC laboratory using a stamped, self-addressed envelope. Symptoms and potential side effects of antibiotics will be collected via a telephone interview. Participants will be informed via a phone call for subsequent vaginal swabs and treatment intake if needed.

At delivery (T2)

All relevant clinical and obstetrical outcomes during pregnancy will be collected from the medical files. To complete data collection, a face-to-face interview with women around delivery phase will be scheduled. All relevant data such as pregnancy complications, hospitalizations, delivery characteristics (including birth weight, terms at delivery, or fetal death) will be collected.

At 6 months after delivery (T3)

Participants will be provided with a questionnaire, on which they will be asked to record all health outcomes of their infant and associated health service use.