To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.
This will be an observational cohort trial of the pregnancy of women who conceive in RMN trials, and of their resulting infants through the first 3 years of life. Study specific procedures will include a patient completed log of prescribed and over the counter medications taken during a normal pregnancy, a review of their pregnancy, delivery, and neonatal records, an exam of the infant within 60 days of birth by a dysmorphologist, and yearly review of infant medical records, growth charts, and a yearly parent administered developmental questionnaire (Ages and Stages) for the first three years of the infant's life.
Study Type
OBSERVATIONAL
Enrollment
264
University of Alabama Birmingham
Birmingham, Alabama, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
The relative risks of genetic abnormalities identified at birth and within the first 60 days of life
Time frame: 2009 - 2016
The relative risk of structural anomalies
Time frame: 2009 - 2016
The relative risk of cognitive differences
Time frame: 2009 - 2016
The relative risk of perceived differences of neuro-developmental milestones
Time frame: 2009 - 2016
The rate of pregnancy complications, including pregnancy loss
Time frame: 2009 - 2016
Rates of neonatal and infant medical disorders
Time frame: 2009 - 2016
Rates of infant growth related to use of letrozole for stimulation of ovulation compared to other treatment modalities for ovulation stimulation, including compared to women who conceive spontaneously.
Time frame: 2009 - 2016
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Yale University
New Haven, Connecticut, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Hackensack University
Hackensack, New Jersey, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, United States
...and 3 more locations