Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)NCT07916727
Specific and Novel Approaches to Care of Inflammatory Bowel Disease During Pregnancy: the PREGO Study
A study testing Dedicated IBD pregnancy care in people with Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) and Pregnancy, run by Austin Health at 7 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), Pregnancy
- What is being tested?
- Dedicated IBD pregnancy care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesAustralia
- Study dates
- 15 Apr 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biologically female adult patients (aged 18 years or older) with a diagnosis of inflammatory bowel disease (IBD) receiving care for their IBD during pregnancy
Who cannot join
- Non-pregnant inflammatory bowel disease patients
- Non-consenting patients
- Age <18
- Pregnant patients with inflammatory bowel disease receiving dedicated IBD pregnancy care at an alternative tertiary institution
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Australia7 sites, 7 recruiting
- Not yet recruiting
Royal Hobart Hospital
Hobart
Jarrad Wilson, +61 (03) 6166 8308, jarrad.wilson@ths.tas.gov.au
- Recruiting
Austin Health
Melbourne
Simone Chin, +61406022754, simone.chin@austin.org.au
- Recruiting
Eastern Health
Melbourne
Natasha Janko, +61 3 8804 9999, Natasha.Janko@easternhealth.org.au
- Recruiting
Mercy Health
Melbourne
Susan Walker, +61 (03) 8458 4444, spwalker@unimelb.edu.au
- Not yet recruiting
Peninsula Health
Melbourne
Ali Eqbal, +61 (03) 9784 7777, AEqbal@phcn.vic.gov.au
- Recruiting
Royal Prince Alfred Hospital
Sydney
Crispin Corte, +61 (02) 9515 6111, crispin.corte@health.nsw.gov.au
- Recruiting
St Vincent's Hospital Darlinghurst
Sydney
Simon Ghaly, +61 (02) 8382 1111, Simon.Ghaly@svha.org.au
About this study
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.
- Being tested
- Dedicated IBD pregnancy care
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated IBD pregnancy careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Participants in the standard of care arm will receive usual care of their IBD during pregnancy, as per local practice. |
| Intervention | Experimental | Participants on the intervention arm will receive dedicated IBD pregnancy care, delivered face-to-face or via telehealth. Receives: Other: Dedicated IBD pregnancy care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to the end of pregnancy
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrolment to end of pregnancy
Clinical outcomes: gestational age at delivery
Defined as number of gestational weeks and days at time of delivery.
Measured: From enrolment to end of pregnancy
Clinical outcomes: mode of delivery
The mode of delivery (Caesarean section vs vaginal delivery) will be recorded.
Measured: From enrolment to end of pregnancy
Clinical outcomes: birthweight
The birthweight of the infant (in kg) will be recorded.
Measured: From enrolment to end of pregnancy
Clinical outcomes: gestational diabetes
The presence or absence of gestational diabetes in pregnancy will be recorded.
Measured: From enrolment to end of pregnancy
Clinical outcomes: preeclampsia
The presence or absence of preeclampsia in pregnancy will be recorded.
Measured: From enrolment to end of pregnancy
Clinical outcomes: placental complications
The presence or absence of placental complications in pregnancy will be recorded.
Measured: From enrolment to end of pregnancy
Clinical outcomes: intrauterine growth restriction
The presence or absence of intrauterine growth restriction in pregnancy will be recorded.
Measured: 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.
Measured: From enrolment to end of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated to either standard of care or interventional model of care. The interventional model of care consists of dedicated IBD pregnancy care, delivered either face-to-face or via telehealth. Allocation to study groups is non-randomised and non-blinded.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Peter De Cruz, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916727
- Sponsor's protocol ID
- HREC/27830/Austin-2025
- Status last verified
- Nov 2026
- First submitted
- 4 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific and Novel Approaches to Care of Inflammatory Bowel Disease During Pregnancy: the PREGO Study
- ClinicalTrials.gov ID
- NCT07916727
- Acronym / sponsor ID
- HREC/27830/Austin-2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Austin HealthOther government
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be allocated to either standard of care or interventional model of care. The interventional model of care consists of dedicated IBD pregnancy care, delivered either face-to-face or via telehealth. Allocation to study groups is non-randomised and non-blinded.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Participants in the standard of care arm will receive usual care of their IBD during pregnancy, as per local practice. |
| Intervention | Experimental | Other: Dedicated IBD pregnancy careParticipants on the intervention arm will receive dedicated IBD pregnancy care, delivered face-to-face or via telehealth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Biologically female adult patients (aged 18 years or older) with a diagnosis of inflammatory bowel disease (IBD) receiving care for their IBD during pregnancy
Key exclusion criteria (4 listed)
- Non-pregnant inflammatory bowel disease patients
- Non-consenting patients
- Age <18
- Pregnant patients with inflammatory bowel disease receiving dedicated IBD pregnancy care at an alternative tertiary institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dedicated IBD pregnancy careDedicated 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. | Other | Intervention |
Primary outcome
Decisional conflict
Time frame: From enrolment to the end of pregnancy
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.
15 secondary outcomes
Patient-reported outcomes: Short IBD Questionnaire
Time frame: From enrolment to end of pregnancy
Patient-reported outcomes: Hospital Anxiety and Depression Scale
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of ambulatory clinic visits per pregnancy
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of emergency department presentations per pregnancy
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of hospitalisations per pregnancy
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of endoscopies undertaken per pregnancy
Time frame: From enrolment to end of pregnancy
Healthcare utilisation: number of intestinal ultrasound(s) undertaken per pregnancy
Time frame: From enrolment to end of pregnancy
Clinical outcomes: gestational age at delivery
Time frame: From enrolment to end of pregnancy
Clinical outcomes: mode of delivery
Time frame: From enrolment to end of pregnancy
Clinical outcomes: birthweight
Time frame: From enrolment to end of pregnancy
Clinical outcomes: gestational diabetes
Time frame: From enrolment to end of pregnancy
Clinical outcomes: preeclampsia
Time frame: From enrolment to end of pregnancy
Clinical outcomes: placental complications
Time frame: From enrolment to end of pregnancy
Clinical outcomes: intrauterine growth restriction
Time frame: From enrolment to end of pregnancy
Clinical outcomes: infant Apgar scores
Time frame: From enrolment to end of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dedicated IBD pregnancy care in people with Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) and Pregnancy, run by Austin Health at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Chin (+61406022754, simone.chin@austin.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: From enrolment to the end of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.