An observational study in Pregnancy Complications, sponsored by Ariella Shitrit. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-02.
Sponsored by Ariella Shitrit · Observational
The safety assessment of Vedolizumab during pregnancy in IBD patients.
The primary objective of this study is:
The IBD MOM clinic currently follows women with IBD from the preconception stage through postpartum period. In addition, we have now started following the offspring for 1 year with an option of extending the follow up until 4 years after birth with participation of the family health center. Data is collected longitudinally on use of non-immunomodulator medications, AZA/6MP, biologic therapy infliximab, adalimumab, certolizumab, and natalizumab. Corticosteroids,5-ASA and Methotrexate), disease activity during gestation, complications of pregnancy and delivery, and infant birth outcomes during the first year of the child's life because from population-based data, including the Kaiser sample1 and studies from Europe2-4 women with IBD clearly have an increased risk of adverse pregnancy outcomes such as preterm birth and/or low birth weight infants, even with inactive disease.10.
Study duration: September 2015- September 2022 This is a non-interventional observational prospective cohort study to be conducted in an actual clinical practice setting.
This is an exposure-based cohort study in which there will be 3 reference groups. Women on conventional therapy only, women on Vedolizumab and women on other biologics.
The source database contains information collected from our IBD MOM clinic in Shaare Zedek Medical Center in Jerusalem, Israel.
437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.
This study's planned enrollment of 200 is below the median of 320 across 205 observational studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →This is the only study on the registry with Ariella Shitrit as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The source population is women attending the IBD MON clinic at Shaare Zedek Medical Center in Jerusalem, Israel.
Inclusion Criteria for the UC/CD Prospective Cohort:
Exclusion Criteria for the UC/CD Prospective Cohort:
The subject has had an exposure to the known or suspected human teratogens:
Any Entyvio exposed mother who does not meet the entry criteria will be entered into an Entyvio case series, which will be used to provide support data to cohort study.
* Group 1a Mothers exposed to Vedolizumab at any time during pregnancy (and up to 3 months prior to last menstrual period \[LMP\], if this information is available). * Group 1b Infants born to Group 1a patients.
* Group 2a Patients with IBD who were exposed to anti-TNFs at any time during pregnancy (and up to 3 months prior to LMP, if this information is available). * Group 2b Infants born to Group 2a patients.
Patients with IBD who were exposed to conventional therapy only any time during pregnancy (and up to 3 months prior to LMP, if this information is available). • Group 3b Infants born to Group 3a patients.
Major body measurements defects of the infant
A major Body measurements defect is defined as a defect that has either cosmetic or functional significance to the child (eg, a cleft lip), as defined by the Centers for Disease Control and Prevention (CDC; \[4\]). These defects in aggregate typically occur in \<4% of the general population. Over 100 specific structural defects are considered to be major. Measurements of head circumference, length, weight, palpebral fissure length, inner canthal distance, ear length, and philtrum length will be taken. These will be compared to mean values for infants of the same age and sex (where sex-specific normative data are available). Less than or greater than 2 standard deviations from the mean will be used to define such terms as microcephaly, hypertelorism, etc.
Time frame: 1 year from birth
Minor body measurements defects of the infant
A minor structural defect is defined as a defect that has neither cosmetic nor functional significance to the child (eg, complete 2,3 syndactyly of the toes) and is identified using a study-related checklist incorporated into the study dysmorphology examination of live born infants. Measurements of head circumference, length, weight, palpebral fissure length, inner canthal distance, ear length, and philtrum length will be taken. These will be compared to mean values for infants of the same age and sex (where sex-specific normative data are available). Less than or greater than 2 standard deviations from the mean will be used to define such terms as microcephaly, hypertelorism, etc.
Time frame: 1 year from birth
Rate of Spontaneous abortion
Non-deliberate embryonic or fetal death
Time frame: Prior to 20 weeks' gestation post-LMP
Rate of Elective abortion
Deliberate termination of pregnanc. Reason for elective abortion will be ascertained.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Rate of Stillbirth
A non-deliberate fetal death
Time frame: After 20 weeks' gestation post-LMP, but prior to delivery
Rate of Premature delivery
Defined as live birth. Elective caesarian deliveries or inductions prior to 37 completed weeks are not considered premature deliveries, and will be considered separately.
Time frame: Prior to 37 completed weeks' gestation post-LMP.
Rate of SGA
Weight, length or head circumference. less than or equal to the 10th percentile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Rate of Postnatal growth deficiency
Weight, length or head circumference) less than or equal to the 10th percentile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age.
Time frame: The size of the infant at the time of postnatal until 1 year of age
Rate of Lost-to-follow-up following the estimated due date
Is defined as an enrolled subject where follow-up information on the outcome (live birth, fetal loss) is not obtainable, or for a live birth if the birth defect status is designated as "unknown". The OTIS Autoimmune Diseases in Pregnancy Project has experienced extremely low losses to follow-up (\<5% of enrolled subjects) by virtue of maintaining consistent contact with the pregnant woman. Before a subject is designated as lost to follow up, the subject or reporter receives at least 3 reminder telephone calls (documented in the database) followed by written correspondence and alternative contact information that is requested upon enrollment is utilized. Voluntary subject withdrawals will be considered separately.
Time frame: 12 months following the estimated due date
Rate of Serious or opportunistic infections
Defined as those listed in Error! Reference source not found., and identified in newborn infants up to 1 year of age, or infections that require hospitalization up to 1 year of age. Pediatric records will be requested with specific requests for documentation of hospitalizations and opportunistic infections.
Time frame: Newborn infants up to 1 year of age
Rate of Malignancies
Defined as any malignancy reported in an infant up to 1 year of age. Pediatric records will be requested with specific requests for documentation of malignancies.
Time frame: Up to 1 year of age of the infant
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