An interventional study of Dedicated IBD pregnancy care in Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) and Pregnancy, sponsored by Austin Health. Recruiting at 7 sites in Australia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Austin Health · Not applicable, Interventional, and Health services research
IBD pregnancy requires multidisciplinary management, but access to this may be difficult for some, resulting in variation in care which may in turn impair quality of healthcare delivery. We need to devise innovative ways to deliver care to overcome these barriers. The PREGO study will interrogate the value of multidisciplinary care in IBD pregnancy, and test a new virtual-based way of improving access to care.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 50 is below the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Austin Health is the lead sponsor of 42 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the standard of care arm will receive usual care of their IBD during pregnancy, as per local practice.
Participants on the intervention arm will receive dedicated IBD pregnancy care, delivered face-to-face or via telehealth.
Other: Dedicated IBD pregnancy care
Dedicated IBD pregnancy care is delivered to participants in the intervention arm. This may be delivered by telehealth or face-to-face depending on the site. Participants in this arm will be reviewed once per trimester during their pregnancy by an IBD gastroenterologist alongside other members of the multidisciplinary team e.g. obstetrics and maternofetal medicine.
Decisional conflict
Shared decision making, as measured by the Decisional Conflict Scale. The Decisional Conflict Scale (DCS), measures decisional conflict by asking participants to respond to a 16 item questionnaire using a five-point Likert scale. Low scores indicate low levels of decisional conflict (better outcome), whilst high scores indicate high levels of decisional conflict (worse outcome). The minimum value is 0. The maximum value is 64. Reference: O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995;15(1):25-30.
Time frame: From enrolment to the end of pregnancy
Patient-reported outcomes: Short IBD Questionnaire
Disease-related quality of life, as measured by the Short IBD Questionnaire. The Short IBD Questionnaire (SIBDQ) measures IBD-related quality of life by asking participants to respond to a 10-item questionnaire using a seven-point Likert scale. High scores indicate high levels of disease-related quality of life (better outcome), whilst low scores indicate low levels of disease-related quality of life (worse outcome). The minimum value is 0. The maximum value is 70. Reference: Irvine EJ, Zhou Q \& Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. The American Journal of Gastroenterology. 1996;91(8):1571-1578.
Time frame: From enrolment to end of pregnancy
Patient-reported outcomes: Hospital Anxiety and Depression Scale
Levels of anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS). The HADS measures levels of anxiety and depression by asking participants to respond to a 14-item questionnaire using a four-point Likert scale. Lower scores indicate lower levels of anxiety or depression (better outcome), whilst higher scores indicate higher levels of anxiety or depression (worse outcome). Normal score: 0-7 Borderline abnormal score: 8-10 Abnormal score: 11-21 The minimum value is 0. The maximum value is 42. Reference: Zigmond AS \& Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361-370.
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of ambulatory clinic visits per pregnancy
Number of ambulatory clinic visits per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy.
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of emergency department presentations per pregnancy
Number of emergency department presentations per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy.
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of hospitalisations per pregnancy
Number of hospitalisations per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy.
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of endoscopies undertaken per pregnancy
Number of endoscopies undertaken per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy.
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of intestinal ultrasound(s) undertaken per pregnancy
Number of intestinal ultrasound(s) undertaken per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy.
Time frame: From enrolment to end of pregnancy
Clinical outcomes: gestational age at delivery
Defined as number of gestational weeks and days at time of delivery.
Time frame: From enrolment to end of pregnancy
Clinical outcomes: mode of delivery
The mode of delivery (Caesarean section vs vaginal delivery) will be recorded.
Time frame: From enrolment to end of pregnancy
Clinical outcomes: birthweight
The birthweight of the infant (in kg) will be recorded.
Time frame: From enrolment to end of pregnancy
Clinical outcomes: gestational diabetes
The presence or absence of gestational diabetes in pregnancy will be recorded.
Time frame: From enrolment to end of pregnancy
Clinical outcomes: preeclampsia
The presence or absence of preeclampsia in pregnancy will be recorded.
Time frame: From enrolment to end of pregnancy
Clinical outcomes: placental complications
The presence or absence of placental complications in pregnancy will be recorded.
Time frame: From enrolment to end of pregnancy
Clinical outcomes: intrauterine growth restriction
The presence or absence of intrauterine growth restriction in pregnancy will be recorded.
Time frame: From enrolment to end of pregnancy
Clinical outcomes: infant Apgar scores
The infant's Apgar score at 1 minute and at 5 minutes will be recorded. The Apgar score considers five criteria scored on a scale of 0-2. A lower score indicates neonatal distress (worse outcome). The minimum value is 0. The maximum value is 10.
Time frame: From enrolment to end of pregnancy
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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