WelZCaVa Ι wellbeing registry for pregnant women with cardiovascular disease

1. Approved 17/07/2023, Antwerp University Hospital (Drie Eikenstraat 655, Edegem, 2650, Belgium; +32 3 821 38 97; ethisch.comite@uza.be), ref: 5571

2. Approved 14/05/2024, University Hospital of Ghent (Corneel Heymanslaan 10, Gent, 9000, Belgium; +329 332 33 36; ethisch.comite@uzgent.be), ref: ONZ-2023-0567

3. Approved 13/06/2024, Ziekenhuis Aan de Stroom (Lindendreef 1, Antwerp, 2600, Belgium; +323 280 34 29; zna.ethische-commissie@zas.be), ref: 5571

4. Submitted 28/10/2024, Leuven University Hospital (Herestraat 49, Leuven, 3000, Belgium; +32 16 34 86 00; ec@uzleuven.be), ref: S68628

Patient-reported outcomes:
1. The possible presence of depressive symptoms is measured using the validated Whooley scale
2. The possible presence of an anxiety disorder is measured using the General Anxiety Disorder 7 questionnaire
3. Autonomy and shared decision-making are assessed using the Mothers on Autonomous Decision Making (MADM) scale
4. Social support is measured using the validated Oslo-3 scale
5. Empowerment is assessed using the validated Pregnancy Related Empowerment Scale (PRES)
6. Symptoms of possible (postnatal) depression, anxiety and suicidal ideation assessed using the Edinburgh Postnatal Depression Scale (EPDS)
7. Mother-infant bonding is assessed using the Mother-Infant Bonding Scale (MIBS). The validated Postpartum Bonding Questionnaire (PBQ) is also administered at the same time to ensure that mother-child bonding has been properly assessed.

Patient-reported experiences:
Patient satisfaction will be measured using the validated Maternity Satisfaction with Care Questionnaire (MSCQ) developed as part of the Born in Belgium study.

The registry will collect these data from the first consultation in a tertiary centre up to and including 12 weeks after delivery (cf. fourth trimester). For each enrolled pregnant woman, there will be at least 4 data collection points: at least 1 data collection point during the perinatal period, depending on the date of enrolment and the current gestational age (cf. trimester 1, 2 or 3) and at least 3 data collection points during the postpartum period (cf. week 1, 6 and 12 postpartum).

Figure 1 of the study protocol provides a visual overview of the respective data collection points for demographics and clinical outcomes. Figure 2 also provides a visual overview of the respective data collection points for the PROMS and PREMS datasets. It is important to note that the date of enrolment during the perinatal period is a highly variable element of the study, where the date of the patient's first registration at the outpatient clinic may vary between trimester 1, 2 or 3. During this perinatal period there will be at least one measurement time per participating patient. However, depending on the patient's exact enrolment date and gestational age, an attempt will be made to provide one data collection point per trimester. Ideally, however, the maximum number of measurement times (one measurement time per trimester) should be achieved, as shown in the figure.

The following set of obstetric, maternal and fetal/neonatal outcomes will be collected from the medical record once at 2 weeks postpartum:
1. The set of maternal and obstetric outcomes listed in Appendix 2 of the study protocol will consist of the following variables: maternal mortality, length of stay, haemorrhage; obstetric outcomes such as abruptio placentae, haemorrhage, emergency caesarean section, rupture of membranes (ROM); left ventricular ejection fraction, cardiomyopathy (CMP), arrhythmia, pulmonary hypertension, thromboembolic complications; hypertension, endocarditis and cardiomyopathy.
2. The set of fetal/neonatal outcomes listed in Appendix 3 of the protocol will consist of the following data: APGAR score, birth weight, length of stay, fetal mortality, reason for preterm birth, neonatal admission, neonatal mortality, intrauterine growth restriction (IUGR) and birth injury.

The registry will collect these data from the first consultation in a tertiary centre up to and including 12 weeks after delivery (cf. fourth trimester). For each enrolled pregnant woman, there will be at least 4 data collection points: at least 1 data collection point during the perinatal period, depending on the date of enrolment and the current gestational age (cf. trimester 1, 2 or 3) and at least 3 data collection points during the postpartum period (cf. week 1, 6 and 12 postpartum).

Figure 1 of the study protocol provides a visual overview of the respective data collection points for demographics and clinical outcomes. Figure 2 also provides a visual overview of the respective data collection points for the PROMS and PREMS datasets. It is important to note that the date of enrolment during the perinatal period is a highly variable element of the study, where the date of the patient's first registration at the outpatient clinic may vary between trimester 1, 2 or 3. During this perinatal period there will be at least one measurement time per participating patient. However, depending on the patient's exact enrolment date and gestational age, an attempt will be made to provide one data collection point per trimester. Ideally, however, the maximum number of measurement times (one measurement time per trimester) should be achieved, as shown in the figure.