Table 1 Database schema
Main forms (minimal dataset) | ||||
|---|---|---|---|---|
Data form | Data level 1 | Data level 2 | Data level 3 | Comments |
Registration | Initials; date of birth; postcode; hospital number; NHS number; number of fetuses; consent to database; consent to storage of baby identifier | Initials, date of birth, hospital number and NHS number are transferred to separate “Patient Details Database”. | ||
Clinic Record | Demographics | Expected date of delivery (EDD) | ||
Gravida | Number of pregnancies, including current | |||
Parity | Number of live births or pregnancies ending at 24+ 0 or more weeks’ gestation | |||
Height (cm) | ||||
Weight (kg) | ||||
BMI (kg/m2) | Calculated from height and weight | |||
Age (at EDD) | Calculated from date of birth and EDD. | |||
Ethnicity | Drop down list | |||
Smoking status | Drop down list | |||
Lower super output area | Postcode converted to lower super output area. | |||
Risk factors/ reasons for referral | Previous preterm birth | Number of previous preterm births and earliest gestation | ||
Previous premature ruptured membranes (PPROM) | Number of previous PPROMs and earliest gestation | |||
Previous late miscarriage | Number of previous late miscarriages and latest gestation | |||
Previous cervical surgery | Number of previous cervical surgeries and most significant procedure | |||
Uterine abnormality | Drop down list | |||
Multiple pregnancy | Enter number | |||
Other risk factors | Drop down list and free text | |||
Preterm clinic visits | Date | Enter date | ||
Gestation | Calculated from date of visit and EDD | |||
Shortest cervical length | ||||
Fetal fibronectin results | ||||
Infection screen results | ||||
Other test results | ||||
Symptoms | None; abdominal/ back pain; tightenings; tightenings and pain; vaginal pressure; PV loss; other | |||
Preterm birth interventions | Type | E.g. cerclage; progesterone; pessary; bedrest; admission | ||
Sub-type | E.g. low vaginal cerclage; high vaginal cerclage; abdominal cerclage | |||
Indication for intervention | History indicated; ultrasound indicated; emergency/rescue | |||
Intervention date | ||||
Gestation | Calculated from EDD and date of intervention | |||
Date of delivery | ||||
Pregnancy outcome | Onset of labour | Spontaneous; induced; pre-labour caesarean | ||
Gestation at delivery | Calculated from EDD and date of delivery | |||
Birthweight | ||||
Maternal outcomes | No significant morbidities; maternal infection or inflammation; pre-labour rupture of membranes; harm to mother from intervention; ITU admission Maternal death | |||
Neonatal outcomes | Livebirth; stillbirth; miscarriage; NNU admission; infection (proven, ≤ 72 h); early neuro-developmental morbidity; late neuro-developmental morbidity; gastro-intestinal morbidity; respiratory morbidity; harm to infant from intervention; neonatal death | |||
Additional data forms | Comments (for additional details if required) | |||
Medical History | Tick and text boxes for recording of medical conditions and current medications. | |||
Obstetric History | Space for recording previous pregnancies: year; gestation, outcome; onset of labour; mode of delivery; preterm birth interventions; gestation at intervention. | |||
Cervical Surgery | Space for recording cervical surgery: year; type; anaesthetic; depth | |||
Antenatal details | Details of preterm interventions; day assessment episodes and antenatal inpatient nights, e.g. tocolysis; steroid administration; antibiotics; progesterone; cerclage; pessary. | |||
Delivery Details | Onset of labour; reason if not spontaneous; magnesium sulphate and antibiotics in labour; markers of maternal infection (e.g. pyrexia, test results); blood loss; date of discharge; number of postnatal nights. | |||
Neonatal Details | Date and time of delivery; gestation at delivery; date and time of rupture of membranes; mode of delivery; gender; birthweight; Apgar scores; congenital abnormalities; NNU admission; neonatal morbidities and death; discharge from hospital; number of inpatient nights (one form created per fetus). | |||
Research Participation Record | Record of patient’s participation in preterm birth research: study name; study ID; date of enrolment; study design; treatment allocation. | |||