Pregnancy Complications Clinical Trial
Official title:
The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient
The safety assessment of Vedolizumab during pregnancy in IBD patients.
The primary objective of this study is:
1. To quantify incidence of major structural birth defects and other birth outcomes in
infants born to women with UC/CD with exposure to Entyvio compared to women with
exposure to other biological agents or conventional IBD therapy during pregnancy
2. To assess the health and developmental status of infants up to 1yr of age.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03249896 -
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
|
N/A | |
Completed |
NCT06338254 -
Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women
|
N/A | |
Recruiting |
NCT04825093 -
Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19
|
N/A | |
Completed |
NCT04739462 -
SMS Maama Project COVID-19
|
N/A | |
Recruiting |
NCT04519593 -
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
|
N/A | |
Recruiting |
NCT03313024 -
Berlin-Brandenburg Pregnancy Cohort
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06357962 -
Semi-permanent Acupuncture Effect on Cervical Ripening
|
N/A | |
Not yet recruiting |
NCT06430853 -
Psychobiological Interventions in Pregnancy
|
N/A | |
Not yet recruiting |
NCT03661749 -
Urinary Protein to Creatinine Ratio in Term Pregnant Women
|
N/A | |
Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
Completed |
NCT02191774 -
Medical Abortion up to 10 Weeks Gestation at Home
|
||
Completed |
NCT01322529 -
Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be
|
N/A | |
Completed |
NCT00746551 -
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
|
Phase 4 | |
Completed |
NCT00678080 -
Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
|
N/A | |
Completed |
NCT00634530 -
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
|
N/A | |
Completed |
NCT00197561 -
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
|
Phase 3 | |
Completed |
NCT05527327 -
Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study
|
N/A | |
Recruiting |
NCT05551078 -
Thrombophilia Screening After Severe IUGR
|
||
Recruiting |
NCT03100084 -
PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome
|