Pregnancy in Greek Female Patients With Inflammatory Bowel Disease - Panhellenic Recording

Pregnancy Related Clinical Trial

Official title:

Pregnancy in Greek Female Patients With Inflammatory Bowel Disease - Panhellenic Recording

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562726
• Other study ID #: 896/2020/21-01-2021
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2023
• Source: Alexandra Hospital, Athens, Greece
• Contact: Spyridon Michopoulos, MD
• Phone: +0302132162367
• Email: michosp5[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients pregnant with Inflammatory Bowel Disease

• patients age >18 years with IBD

Exclusion Criteria:

• Termination of pregnancy in the first trimester

• Miscarriage of pregnancy

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Pregnancy Related

Locations

Country	Name	City	State
Greece	Alexandra General Hospital Greece	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Alexandra Hospital, Athens, Greece

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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 Infl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy.	the management of the pregnant IBD patients in Greece	01/01/2020-31/12/2023
Primary	Data will be obtained regarding IBD pregnancy outcomes and delivery mode.	the management of the pregnant IBD patients in Greece	01/01/2020-31/12/2023
Primary	Data will be obtained regarding lactation and health status of the offspring.	the management of the pregnant IBD patients in Greece	01/01/2020-31/12/2023