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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Spyridon Michopoulos, MD contact

+0302132162367

michosp5@gmail.com

Greece1 site, 1 recruiting
  • Alexandra General Hospital Greece

    Athens, 11528

    Spyridon Michopoulos, PI, +0302132162367, michosp5@gmail.com

    Evanthia Zampeli, PI, +0302132162367, evazamb@gmail.com

    Recruiting

Other trials in Greece

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.

Medical subject headings
Inflammatory Bowel Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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.

  1. First posted3 Oct 2022
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Resources

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
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

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.

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