Table 2

Main items of the final core data set for pregnancy registries in rheumatology and their operationalisation and instruments for assessment

No.Main itemsOperationalisation/instruments for assessment
Maternal information
Demographics and risk behaviours
1 AgeDate of birth or month/year of birth
2 Heightcm
3 Weight before (or in early) pregnancykg
4 Educational levelHighest educational level according to national standards or/total years of completed education
5 Alcohol consumption during pregnancyCategorisation: yes/no
6 Smoking during pregnancyCategorisation: yes/no
IRD disease characteristics
7 IRD diagnosisPhysician reported clinical diagnosis*
8 Classification criteriaIndication, which criteria are fulfilled
9 Disease durationMonth/year or year of diagnosis
10 Physician reported IRD severityNRS or VAS
11 Auto-antibodies†See additional recommendations (table 3)
12 Physician reported flaresAssessment of (1) yes/no; (2) number of flares
13 Physician reported disease activityNRS or VAS
14 Disease activity by score†See additional recommendations (table 3)
15 C reactive proteineg, mg/L
16 Patient reported disease activityNRS or VAS
17 Patient reported global healthNRS or VAS
Prevalent comorbidities
18 Selected prevalent comorbiditiesYes/no assessment of: (1) antiphospholipid syndrome, (2) diabetes mellitus, (3) arterial hypertension, (4) renal disease, (5) previous thromboembolic events
Pregnancy
Obstetrical history
19 GravidityNumber
20 ParityNumber
21 Outcome of previous pregnancy(ies)Categorised into foetal death (including pregnancy loss and stillbirths)/live birth; assessment of (1) number of foetal deaths and live births; (2) gestational age
22 Preterm birth(s)Number
23 Neonatal death(s)Number
24 Congenital malformationsFree text
25 Hypertensive pregnancy disordersYes/no assessment of: pre-eclampsia, eclampsia, HELLP syndrome
Course of current pregnancy
26 Planned pregnancyYes/No
27 Assisted reproductionYes/No
28 Estimated date of conceptionDay/Month/Year
29 Singleton/*-/multiple pregnancyNumber of foetuses
30 Adverse events of interest(1) Yes/no assessment of non-serious and serious events of: (a) gestational hypertension, (b) pre-eclampsia, eclampsia, HELLP syndrome, (c) gestational diabetes, (d) thromboembolic events; (2) date of the beginning of the event; (3) indication if the event has led to hospitalisation or death‡
31 Other serious adverse eventsAssessment of (1) the kind of event as free text; (2) date of the beginning of the event; (3) indication if the event has led to hospitalisation or death‡
Delivery/outcome of the current pregnancy
32 Elective terminationAssessment of (1) yes/no; (2) gestational age; (3) reasons for termination categorised into (a) termination due to malformation, (b) termination due to other reasons
33 Foetal deathIncluding pregnancy loss and stillbirths; assessment of (1) yes/no; (2) gestational age (weeks) at diagnosis
34 Live birthYes/No
35 Gestational age at deliveryIn weeks and days
36 Preterm premature rupture of membranesYes/No
37 Mode of delivery(1) Categorised into spontaneous vaginal delivery/operative vaginal delivery/caesarean section (CS)/mode of delivery not specified, and in case of CS (2) reasons categorised into: elective CS/foetal reasons/maternal reasons/combined foetal and maternal reasons/unknown reasons
Neonatal outcomes
38 Birth weightIn kilogram with two decimal digits or gram
39 GenderCategorisation: female/male/other
40 Breast feedingCategorisation: yes, for at least 4 weeks after birth/no
41 Congenital heart blockYes/No
42 Congenital malformationsFree text
43 Neonatal serious adverse events during the first 28 days of liveAssessment of (1) the kind of event as free text; (2) date of the beginning of the event; (3) indication if the event has led to hospitalisation or death‡
Treatment
Treatment 12 months prior to conception
44 DMARD useAssessment of (I) yes/no; (2) name§; (3) start/stop dates
45 Oral glucocorticoid useYes/No
46 Use of potentially teratogenic medicationFree text
IRD treatment during pregnancy and post partum
47 DMARD useAssessment of (1) yes/no; (2) name§; (3) dose; (4) application intervals; (5) start/stop dates; (6) reasons for discontinuation
48 Oral glucocorticoid useAssessment of (1) yes/no; (2) dose; (3) application intervals; (4) start/stop dates
49 Intraarticular glucocorticoid useAssessment of (1) yes/no; (2) date of application
50 NSAID useAssessment of (1) yes/no; (2) name; (3) start/stop dates
Use of other treatments during pregnancy
51 Use of selected treatmentsYes/no assessment of use of (1) antihypertensive drugs, (2) aspirin, (3) folic acid and (4) heparin/other anticoagulants
  • Explanations of the main items are given in online supplemental table 4.

  • *Which diagnoses are covered by the registry, must defined in advance by every registry.

  • †Variables differ according to IRD diagnosis and are further defined in table 3.

  • ‡This recommendation is based on the ICH E2A guideline.25

  • §For biological or targeted synthetic disease modifying antirheumatic drugs it is recommended to record the trade name.

  • DMARD, disease modifying anti-rheumatic drug; HELLP, complication of pregnancy characterised by haemolysis, elevated liver enzymes and a low platelet count; IRD, inflammatory rheumatic disease; NRS, Numeric Rating Scale; NSAID, non-steroidal anti-inflammatory drug; VAS, Visual Analogue Scale.