Inflammatory Bowel DiseasesNCT05562726
Pregnancy in Greek Female Patients With Inflammatory Bowel Disease - Panhellenic Recording
An observational study of Inflammatory Bowel Diseases and Pregnancy Related, run by Alexandra Hospital, Athens, Greece at 1 site in Greece.
Trial summary
The aim of the present study is to retrospectively record all the successful pregnancies in Greek IBD patients within the last 10 years and prospectively record all the future pregnancies for the next 4 years. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Pregnancy Related
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2020to 1 Jul 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female pregnant IBD patients in Greece
Who may be able to join
- Patients pregnant with Inflammatory Bowel Disease
- patients age >18 years with IBD
Who cannot join
- Termination of pregnancy in the first trimester
- Miscarriage of pregnancy
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Alexandra General Hospital Greece
Athens, 11528
Spyridon Michopoulos, PI, +0302132162367, michosp5@gmail.com
Evanthia Zampeli, PI, +0302132162367, evazamb@gmail.com
About this study
The aim of the present study is to retrospectively record all the successful pregnancies in Greek IBD patients within the last 10 years and prospectively record all the future pregnancies for the next 4 years. Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy, pregnancy outcomes, delivery mode, lactation and health status of the offspring. Moreover, the management of the pregnant IBD patients in Greece will be analyzed and compared to the European guidelines, in an effort to develop a position statement applicable to the Greek NHS.
Read the detailed description
Inflammatory bowel disease (IBD) commonly affects patients during their reproductive years, making the interaction between fertility, pregnancy, and IBD an important issue for the IBD specialists. In general, non-surgically treated female patients with IBD appear to have similar fertility rates to the general population. An observed reduction in fertility in Crohn's disease (CD) female patients was linked to voluntary childlessness, while there was no evidence of physiological causes of infertility except for those who had underwent surgical procedures. Concerning the risk of developing IBD, children with one parent affected with IBD have a 2-13 times higher overall risk than the general population. The risk is higher for CD, transmission is more common from mother to child, and female offspring are at higher risk , indicating a specific female sex inheritance pattern. The natural course of IBD involves fluctuating disease activity, where periods of clinical remission are interrupted by flares of increased bowel inflammation. Disease activity at conception and during pregnancy seems to be an important risk factor for adverse pregnancy outcomes (preterm birth, low birthweight, small for gestational age neonates, low Apgar score, and hypoglycemia). 3 Moreover, conception occurring at a time of active disease increases the risk of persistent activity during pregnancy although the overall influence of the pregnancy on the course of IBD is positive with a lower relapse rate and decreased needs for surgical interventions in the years after. If conception occurs at a time of quiescent disease, the risk of relapse is the same as in nonpregnant women. Consequently, appropriate treatment of IBD should be maintained in those patients who wish to conceive and acute flares during pregnancy be treated without delay. In cases of relapse, depending on the disease phenotype and activity, 5-ASA or corticosteroids are the preferred therapies but anti-TNF agents can be considered to treat flares in appropriate situations. Most drugs used for the treatment of IBD are considered to be of low risk during pregnancy. The use of 5-ASA derivatives (with the exception of formulation with dibutylphthalate coating, Asacol®), corticosteroids, thiopurines, and biologicals is not associated with significant maternal or neonatal adverse outcomes in pregnant IBD patients, however, methotrexate is contraindicated. Surgical procedures in pregnant IBD patients have the same indications as in nonpregnant women but decisions should be made on an individual basis, considering that continued severe illness is a greater risk to the fetus than surgical intervention. Also, endoscopy can be safely performed during pregnancy but should be reserved for strong indications because of the potential maternal and fetal complications. Concerning the delivery mode, cesarean section is indicated in active perianal disease or active rectal involvement. Most studies have shown significantly increased frequency of cesarean section in IBD patients but this issue is subject to a multidisciplinary approach and should primarily be governed by obstetric indications.
In conclusion, data from the existing bibliography indicate that:
Women with UC and CD have increased risk of adverse birth outcomes and for most of them the risk increase was found among women with flaring disease during pregnancy. Very few studies have evaluated whether there is an effect of IBD on first-trimester outcome of pregnancy (i.e. increased chance of miscarriage or an ectopic pregnancy) and whether there is an effect on the rate of complications of pregnancy (placental abruption, chorioamnionitis, preeclampsia/eclampsia, placenta previa, premature and prolonged rupture of membranes).
Follow-up studies on the long-term health status of the offspring are limited. In Greece, the data on pregnancy in IBD patients are scarce and never recorded systematically.
- Conditions
- Inflammatory Bowel Diseases, Pregnancy Related
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy.
the management of the pregnant IBD patients in Greece
Measured: 01/01/2020-31/12/2023
Data will be obtained regarding IBD pregnancy outcomes and delivery mode.
the management of the pregnant IBD patients in Greece
Measured: 01/01/2020-31/12/2023
Data will be obtained regarding lactation and health status of the offspring.
the management of the pregnant IBD patients in Greece
Measured: 01/01/2020-31/12/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital, Athens, Greece
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SPYRIDON MICHOPOULOS, Alexandra Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562726
- Sponsor's protocol ID
- 896/2020/21-01-2021
- Status last verified
- Jan 2023
- First submitted
- 28 Sep 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mahadevan U, Long MD, Kane SV, Roy A, Dubinsky MC, Sands BE, Cohen RD, Chambers CD, Sandborn WJ; Crohn's Colitis Foundation Clinical Research Alliance. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease. Gastroenterology. 2021 Mar;160(4):1131-1139. doi: 10.1053/j.gastro.2020.11.038. Epub 2020 Nov 21.
PubMed 33227283
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy in Greek Female Patients With Inflammatory Bowel Disease - Panhellenic Recording
- ClinicalTrials.gov ID
- NCT05562726
- Acronym / sponsor ID
- 896/2020/21-01-2021
- Conditions
- Inflammatory Bowel Diseases, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandra Hospital, Athens, GreeceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 3 Oct 2022 (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.
The aim of the present study is to retrospectively record all the successful pregnancies in Greek IBD patients within the last 10 years and prospectively record all the future pregnancies for the next 4 years. Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy, pregnancy outcomes, delivery mode, lactation and health status of the offspring. Moreover, the management of the pregnant IBD patients in Greece will be analyzed and compared to the European guidelines, in an effort to develop a position statement applicable to the Greek NHS.
Detailed description
Inflammatory bowel disease (IBD) commonly affects patients during their reproductive years, making the interaction between fertility, pregnancy, and IBD an important issue for the IBD specialists. In general, non-surgically treated female patients with IBD appear to have similar fertility rates to the general population. An observed reduction in fertility in Crohn's disease (CD) female patients was linked to voluntary childlessness, while there was no evidence of physiological causes of infertility except for those who had underwent surgical procedures. Concerning the risk of developing IBD, children with one parent affected with IBD have a 2-13 times higher overall risk than the general population. The risk is higher for CD, transmission is more common from mother to child, and female offspring are at higher risk , indicating a specific female sex inheritance pattern. The natural course of IBD involves fluctuating disease activity, where periods of clinical remission are interrupted by flares of increased bowel inflammation. Disease activity at conception and during pregnancy seems to be an important risk factor for adverse pregnancy outcomes (preterm birth, low birthweight, small for gestational age neonates, low Apgar score, and hypoglycemia). 3 Moreover, conception occurring at a time of active disease increases the risk of persistent activity during pregnancy although the overall influence of the pregnancy on the course of IBD is positive with a lower relapse rate and decreased needs for surgical interventions in the years after. If conception occurs at a time of quiescent disease, the risk of relapse is the same as in nonpregnant women. Consequently, appropriate treatment of IBD should be maintained in those patients who wish to conceive and acute flares during pregnancy be treated without delay. In cases of relapse, depending on the disease phenotype and activity, 5-ASA or corticosteroids are the preferred therapies but anti-TNF agents can be considered to treat flares in appropriate situations. Most drugs used for the treatment of IBD are considered to be of low risk during pregnancy. The use of 5-ASA derivatives (with the exception of formulation with dibutylphthalate coating, Asacol®), corticosteroids, thiopurines, and biologicals is not associated with significant maternal or neonatal adverse outcomes in pregnant IBD patients, however, methotrexate is contraindicated. Surgical procedures in pregnant IBD patients have the same indications as in nonpregnant women but decisions should be made on an individual basis, considering that continued severe illness is a greater risk to the fetus than surgical intervention. Also, endoscopy can be safely performed during pregnancy but should be reserved for strong indications because of the potential maternal and fetal complications. Concerning the delivery mode, cesarean section is indicated in active perianal disease or active rectal involvement. Most studies have shown significantly increased frequency of cesarean section in IBD patients but this issue is subject to a multidisciplinary approach and should primarily be governed by obstetric indications.
In conclusion, data from the existing bibliography indicate that:
Women with UC and CD have increased risk of adverse birth outcomes and for most of them the risk increase was found among women with flaring disease during pregnancy. Very few studies have evaluated whether there is an effect of IBD on first-trimester outcome of pregnancy (i.e. increased chance of miscarriage or an ectopic pregnancy) and whether there is an effect on the rate of complications of pregnancy (placental abruption, chorioamnionitis, preeclampsia/eclampsia, placenta previa, premature and prolonged rupture of membranes).
Follow-up studies on the long-term health status of the offspring are limited. In Greece, the data on pregnancy in IBD patients are scarce and never recorded systematically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female pregnant IBD patients in Greece
Key inclusion criteria (2 listed)
- Patients pregnant with Inflammatory Bowel Disease
- patients age >18 years with IBD
Key exclusion criteria (2 listed)
- Termination of pregnancy in the first trimester
- Miscarriage of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy.
Time frame: 01/01/2020-31/12/2023
the management of the pregnant IBD patients in Greece
Data will be obtained regarding IBD pregnancy outcomes and delivery mode.
Time frame: 01/01/2020-31/12/2023
the management of the pregnant IBD patients in Greece
Data will be obtained regarding lactation and health status of the offspring.
Time frame: 01/01/2020-31/12/2023
the management of the pregnant IBD patients in Greece
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Results publication: PubMed 33227283Mahadevan U, Long MD, Kane SV, Roy A, Dubinsky MC, Sands BE, Cohen RD, Chambers CD, Sandborn WJ; Crohn's Colitis Foundation Clinical Research Alliance. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease. Gastroenterology. 2021 Mar;160(4):1131-1139. doi: 10.1053/j.gastro.2020.11.038. Epub 2020 Nov 21.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Pregnancy Related, run by Alexandra Hospital, Athens, Greece at 1 site in Greece.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Spyridon Michopoulos, MD (+0302132162367, michosp5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy. (time frame: 01/01/2020-31/12/2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562726, which also lists 1 linked publication.
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 2 Feb 2023.