Specific and Novel Approaches to Care of Inflammatory Bowel Disease During Pregnancy: the PREGO Study
NCT07916727, Not applicable, Recruiting, Austin Health
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Specific and Novel Approaches to Care of Inflammatory Bowel Disease During Pregnancy: the PREGO Study | ClinicalTrials.gov |
| NCT number | NCT07916727 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Austin Health | ClinicalTrials.gov |
| Conditions | Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), Pregnancy | ClinicalTrials.gov |
| Interventions | Dedicated IBD pregnancy care | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Decisional conflict | 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. | ClinicalTrials.gov |
| Secondary | Patient-reported outcomes: Short IBD Questionnaire | From enrolment to end of pregnancy | 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. | ClinicalTrials.gov |
| Secondary | Patient-reported outcomes: Hospital Anxiety and Depression Scale | From enrolment to end of pregnancy | 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. | ClinicalTrials.gov |
| Secondary | Healthcare utilisation: number of ambulatory clinic visits per pregnancy | From enrolment to end of pregnancy | Number of ambulatory clinic visits per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy. | ClinicalTrials.gov |
| Secondary | Healthcare utilisation: number of emergency department presentations per pregnancy | From enrolment to end of pregnancy | Number of emergency department presentations per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy. | ClinicalTrials.gov |
| Secondary | Healthcare utilisation: number of hospitalisations per pregnancy | From enrolment to end of pregnancy | Number of hospitalisations per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy. | ClinicalTrials.gov |
| Secondary | Healthcare utilisation: number of endoscopies undertaken per pregnancy | From enrolment to end of pregnancy | Number of endoscopies undertaken per pregnancy will be recorded as raw numbers and used as an indicator of healthcare utilisation during pregnancy. | ClinicalTrials.gov |
| Secondary | Healthcare utilisation: number of intestinal ultrasound(s) undertaken per pregnancy | From enrolment to end of 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. | ClinicalTrials.gov |
| Secondary | Clinical outcomes: gestational age at delivery | From enrolment to end of pregnancy | Defined as number of gestational weeks and days at time of delivery. | ClinicalTrials.gov |
| Secondary | Clinical outcomes: mode of delivery | From enrolment to end of pregnancy | The mode of delivery (Caesarean section vs vaginal delivery) will be recorded. | ClinicalTrials.gov |
| Secondary | Clinical outcomes: birthweight | From enrolment to end of pregnancy | The birthweight of the infant (in kg) will be recorded. | ClinicalTrials.gov |
| Secondary | Clinical outcomes: gestational diabetes | From enrolment to end of pregnancy | The presence or absence of gestational diabetes in pregnancy will be recorded. | ClinicalTrials.gov |
| Secondary | Clinical outcomes: preeclampsia | From enrolment to end of pregnancy | The presence or absence of preeclampsia in pregnancy will be recorded. | ClinicalTrials.gov |
| Secondary | Clinical outcomes: placental complications | From enrolment to end of pregnancy | The presence or absence of placental complications in pregnancy will be recorded. | ClinicalTrials.gov |
| Secondary | Clinical outcomes: intrauterine growth restriction | From enrolment to end of pregnancy | The presence or absence of intrauterine growth restriction in pregnancy will be recorded. | ClinicalTrials.gov |
| Secondary | Clinical outcomes: infant Apgar scores | From enrolment to end of pregnancy | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)