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临床试验/NCT05562726
NCT05562726招募中不适用

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

Alexandra Hospital, Athens, Greece1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Data will be obtained regarding IBD pregnancy outcomes and delivery mode.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients pregnant with Inflammatory Bowel Disease
  • patients age >18 years with IBD

排除标准

  • Termination of pregnancy in the first trimester
  • Miscarriage of pregnancy

结局指标

主要结局

Data will be obtained regarding IBD pregnancy outcomes and delivery mode.

时间窗: 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.

时间窗: 01/01/2020-31/12/2023

the management of the pregnant IBD patients in Greece

Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy.

时间窗: 01/01/2020-31/12/2023

the management of the pregnant IBD patients in Greece

次要结局

未报告次要终点

研究者

发起方
Alexandra Hospital, Athens, Greece
申办方类型
Other
责任方
Principal Investigator
主要研究者

SPYRIDON MICHOPOULOS

Head of the Gastroenterology Department Alexandra General Hospital Athens Greece

Alexandra Hospital, Athens, Greece

研究点 (1)

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