pregnant patients with cytologically (IIID2, IVa-p, IVb-p, IVa-g, IVb-g, V-p, V-g) and/or histologically confirmed CIN 2+ or AIS+ during pregnancy Z34 N87 D06
Conditions
Interventions
Group 1: Register arm / observational cohort
Inclusion of pregnant patients with cytologically (IIID2, IVa-p, IVb-p, IVa-g, IVb-g, V-p, V-g) and/or histologically confirmed CIN 2+ or AIS+ during pregnancy who present at one of the participating
Sponsors
Department für Frauengesundheit, Universitätsklinikum Tübingen
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnancy at the time of presentation Cytological findings of IIID2, IVa-p, IVb-p, IVa-g, IVb-g, V-p, V-g, and/or histologically confirmed CIN 2+ or AIS+ during pregnancy Fluency in German or English Written informed consent
Exclusion criteria
Exclusion criteria: Lack of patient consent Poor compliance or inability to understand the purpose of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence, remission, persistence, and progression of CIN 2+/AIS+ during pregnancy—assessed by colposcopy, cytology, and histology at the initial visit and at follow-up appointments every 8–10 weeks until 6–12 weeks postpartum over a 10-year period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy outcomes (mode of delivery, gestational age, birth weight, APGAR score, pH, complications) Impact of dysplasias on pregnancy outcomes Assessment of the safety of conservative management for mother and child Frequency of surgical interventions during pregnancy | — |
Countries
Germany
Contacts
Public ContactMelanie Henes
Department für Frauengesundheit, Universitätsklinikum Tübingen
Outcome results
None listed