Crohn Disease, Delivery Problem, Fertility Disorders, Inflammatory Bowel Diseases, Pregnancy Complications, Ulcerative Colitis
Conditions
Keywords
Crohn's disease, ulcerative colitis, surgery
Brief summary
Crohn's disease and Ulcerative colitis are chronic disease that are usually diagnosed at young age. The diseases and the associated treatment can impact on patient's sexual function, fertility, pregnancy, and delivery. This study aims to assess the impact of inflammatory bowel diseases on these aspects in female patients.
Detailed description
This is a cross-sectional, international, multicentre study. Female patients diagnosed with inflammatory bowel diseases (Crohn's disease and ulcerative colitis) treated at several Italian centres will be retrospectively assessed for inclusion. Those who underwent surgery below the age of 35 years between 2000 and 2020 will be included. The study aims to obtain information on female fertility, pregnancy and delivery, and to identify factors associated with infertility and problems to conclude the pregnancy. For each nation, at least one centre will collect data on patients who were not treated with surgery. Patients who meet inclusion criteria will be asked to prospectively fill a questionnaire on fertility and pregnancy. Data on treatments and demographic will be retrospectively collected by the local investigators and uploaded on a secure online database.
Interventions
PROCEDUREAny surgery
Any surgical procedures performed for inflammatory bowel diseases
PROCEDUREAny medical treatment
Any treatment (including non-surgical) performed for inflammatory bowel diseases
Sponsors
University of Bologna
University of Rome Tor Vergata
Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
University of Campania Luigi Vanvitelli
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Crohn's disease diagnosis * ulcerative disease diagnosis * operated on before 36 years of age
Exclusion criteria
* younger than 18 years old at follow-up * no definitive diagnosis * no surgical procedures performed A subgroup of patients who did not undergo surgery will be used, at least one for each country.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertility | through study completion, an average of 1 year | Rate of infertility and number of pregnancies. Number of attempts to achieve pregnancy. |
| Pregnancy | through study completion, an average of 1 year | Rate of successful pregnancies. Number of miscarriages. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications, surgical | through study completion, an average of 1 year | Incidence of early and late surgical complications and effects on fertility |
| In-vitro fertilization | through study completion, an average of 1 year | Number of in-vitro fertilization attempts |
| Surgical approach | through study completion, an average of 1 year | Rate of minimally invasive surgery use and effect on fertility and pregnancy |
| Complications, medical | through study completion, an average of 1 year | Incidence of medical complications and effects on fertility |
| Abortion/s | through study completion, an average of 1 year | Number of abortions and reasons. |
Countries
Italy
Contacts
Primary ContactGianluca Pellino, MD, PhD
Outcome results
None listed