Pregnancy in the presence of underlying chronic diseases O99.0 O99.1 O99.2 O99.3 O99.4 O99.5 O99.6 O99.7 O99.8
Conditions
Interventions
Group 1: This is an observational study. Starting with recruitment, all four groups (S, K1-K3) receive the same ‘intervention’, namely risk-adjusted care during pregnancy. Differences between the grou
(2) singleton vs. twin pregnancy
(3) outpatient vs. inpatient recruitment. For each pregnant woman recruited in S/K1, the subsequent pregnant woman who presents at the study center and meets the matching criteria for K2 and K3 will b
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: All women presenting as outpatients at the Department of Obstetrics and Prenatal Medicine, University Bonn Medical School, are screened for eligibility (criteria for group S, K1, K2 and K3 see above). The outpatient department consists of three units: Maternal Medicine Unit; At-Risk Pregnancies Unit; Midwifery Unit. Recruitment takes place in all three units. Additionally, all pregnant women admitted as inpatients to the study center will be screened for eligibility. If a woman meets the inclusion criteria for one of the four study groups, she will be informed about the study and - after providing written informed consent - recruited for the study. Women without written informed consent will not be enrolled in the study.
Exclusion criteria
Exclusion criteria: Higher-order multiple pregnancies (>2 fetuses) and individuals who are not capable to understand the study intention and goal due to language barriers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal and perinatal outcome of pregnancies in women with pre-existing disorder(s). Assessment of severe maternal morbidity and neonatal complications by retrieving ICD-10 and OPS codes (version 2022) of the institutional documentation system (ORBIS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Part (I): Course of pregnancy and birth in women with pre-existing disorders; effect of risk-adjusted care. Survey of all outpatient consultations and inpatient hospital stays. Part (II): Comparison of costs and reimbursement Assessment by query of the study center’s database (SAP). Part (III): Pregnancy and birth experience of women with pre-existing disorders. Assessment through questionnaires / interviews at predetermined time points. | — |
Countries
Germany
Contacts
Public ContactWaltraut M. Merz
Abteilung für Geburtshilfe und Pränatale Medizin Zentrum für Geburtshilfe und Frauenheilkunde Universitätsklinikum Bonn
Outcome results
None listed