Diseases and Abnormalities at or Before Birth

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Congenital Abnormalities

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Susan S Roberts, PhD

The Uterine Fibroid Pregnancy Registry is a USA and European-based registry designed to monitor pregnancies in women with uterine fibroids in order to

1. estimate the risk ratio of birth defects in women with uterine fibroids who were treated or untreated during pregnancy and
2. detect any pattern of birth defects among pregnancies in specific treatment groups.

Those pregnant women exposed to various therapies used to treat uterine fibroids will be compared with those not exposed to treatment in order to detect any potential increase in the risk of major birth defects.

This is a prospective, observational, registration and follow-up study of patients with uterine fibroids who become pregnant and their offspring. Those who are exposed to treatment at any time during pregnancy or within one month of conception will be compared with those not exposed to treatment. Enrollment of patients into the Registry may be initiated by health care providers and/or pregnant patients. Health care providers provide all information related to the pregnancy and the outcome.

During the study, data will be collected on uterine fibroids, exposure to treatment for uterine fibroids, potential confounding factors, and pregnancy outcome. Reported cases will be reviewed and classified according to type of birth defects. Registry enrollment is voluntary and should occur as early in pregnancy as possible, preferably before any prenatal testing. Midway between enrollment and the expected date of delivery, the Registry conducts a short interim follow-up with the health care provider to supplement registration data. Near the estimated date of delivery, the Registry prompts the health care provider to provide pregnancy outcome data. The data elements requested include:

* Health care provider contact information
* Eligibility criteria
* Uterine fibroid treatment (30 days prior to conception and during pregnancy and includes non-steroidal anti-inflammatory drugs, oral contraceptive pills, progestational agents, gonadotropin-releasing hormone (GnRH) agonists, and other oral agents)
* Pregnancy/Birth outcome
* Maternal information
* Prenatal tests
* Uterine fibroid classification

If a live birth is reported, the Registry conducts the follow-up with the infant's health care provider within 2 months of birth, and at 12 months of age. If a birth defect is indicated, the Registry will request additional targeted follow-up information from the health care provider. Data on any adverse event will be forwarded to the Sponsors.

Uterine Fibroid Pregnancy Registry

Syneos Health

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Abortion, Spontaneous

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Hormones

Vincent F Garry, MD

This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.

Pesticides--Health Fertility and Reproductive Risk

National Institute of Environmental Health Sciences (NIEHS)

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Diabetes Mellitus

Polycystic Ovary Syndrome

Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

Metformin

Insulin

Insulin, Globin Zinc

Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).

Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to any drug not known as a major teratogen or fetotoxicant and different than metformin, insulin or any other hypoglycaemic agent.

This is not an intervention but an observed exposure.

metformin

any drug not known as a major teratogen or major fetotoxicant

This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes.

Safety of Metformin in Pregnancy

Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study

Centre Hospitalier Universitaire Vaudois

Senior research associate

Immune System Diseases

Musculoskeletal Diseases

Digestive System Diseases

Autoimmune Diseases

Necrosis

Arthritis

Arthritis, Rheumatoid

Crohn Disease

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Tumor Necrosis Factor Inhibitors

Adalimumab

Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have used adalimumab in the first trimester of pregnancy for any length of time from the date of conception.

Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have not used adalimumab or any TNF antagonist in pregnancy.

Pregnant women without a current diagnosis of an autoimmune disease and who have not used adalimumab or any TNF antagonist at any time in pregnancy nor have they been exposed to any known human teratogen during pregnancy.

Pregnant women who have used adalimumab for any length of time following the first day of the last menstrual period until the end of pregnancy who do not meet Cohort 1 inclusionary criteria.

Kenneth L Jones, MD

The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as, more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

OTIS Autoimmune Diseases in Pregnancy Project

Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project

The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects of newborns.

One secondary objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to potential minor malformations.

Another objective of the study is to evaluate the effects of certain medications when used during pregnancy with respect to spontaneous abortion, stillbirth, and preterm delivery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Uterine Fibroid Pregnancy Registry	NCT00232713	Birth Defects Pregnancy Uterine Fibroid...		20 Years - 55 Years	Syneos Health
Pesticides--Health Fertility and Reproductive Risk	NCT00015561	Birth Defects Miscarriages Cancer		18 Years - 70 Years	National Institute of Environmental Health Sciences (NIEHS)
Safety of Metformin in Pregnancy	NCT02793505	Pregnancy Pregestational ... Polycystic Ovar...	metformin any drug not kn...	-	Centre Hospitalier Universitaire Vaudois
OTIS Autoimmune Diseases in Pregnancy Project	NCT01086059	Crohn's Disease Rheumatoid Arth...		-	University of California, San Diego
OTIS Autoimmune Diseases in Pregnancy Project	NCT01086059	Crohn's Disease Rheumatoid Arth...		-	University of California, San Diego
OTIS Autoimmune Diseases in Pregnancy Project	NCT01086059	Crohn's Disease Rheumatoid Arth...		-	University of California, San Diego

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