The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.
The overarching objectives of the National Pregnancy Registry for Psychiatric Medications are twofold: to assess risk for malformations among infants exposed to specific psychiatric medications and to assess neonatal outcomes associated with prenatal exposure to such medication. Specifically, the Registry will allow us to prospectively determine whether exposure to psychiatric medication is associated with any increased risk for major malformations above the baseline risk noted in the general population. This will be achieved by careful systematic documentation of medication exposure during pregnancy, as well as other relevant exposures often not included in small case series or published reviews of drug safety derived from large administrative databases. Although psychiatric medications are widely used by reproductive age women, reliable data regarding the reproductive safety of many of these compounds is limited. As a result, clinicians often lack sufficient evidence to evaluate the risks and benefits of using medications to treat psychiatric disorders during pregnancy. The National Pregnancy Registry for Psychiatric Medications is one of the first, and largest, hospital-based pregnancy registries which will systematically and prospectively monitor pregnancy outcomes after exposure to psychiatric medications, including antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics. Primary Aim: To prospectively evaluate rates of congenital malformations among infants exposed in-utero to psychiatric medications. Secondary Aims: 1. To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics. 2. To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy. 3. To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.
Study Type
OBSERVATIONAL
Enrollment
5,000
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMajor Malformations in Infants
The primary outcome for this study is rates of major malformations among infants exposed in-utero to psychiatric medications. A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Exclusions include (1) minor anomalies; (2) deformations; (3) physiologic features due to prematurity, such as undescended testes; (4) birthmarks; (5) genetic disorders and chromosomal abnormalities; and (6) any finding by prenatal sonography, such as absence of 1 kidney, or at surgery (or autopsy) that was not identified by an examining pediatrician. This data is collected through review of pediatric medical records through the first twelve months of infants' lives.
Time frame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Maternal Gestational Weight Gain
Maternal gestational weight gain is measured by the change in maternal weight from pre-pregnancy to weight at delivery, recorded in pounds.
Time frame: Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.
Live Birth
Did the pregnancy end in a live birth, assessed as a yes/no outcome.
Time frame: Birth; assessed at 8-12 weeks postpartum.
Spontaneous Abortion (SAB)
Did a spontaneous abortion (SAB) occur during the pregnancy, assessed as a yes/no outcome.
Time frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
Intrauterine Fetal Demise (IUFD)
Did intrauterine fetal demise (IUFD) occur during the pregnancy, assessed as a yes/no outcome.
Time frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
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Gestational Age
The gestational age of the infant at birth, recorded in weeks and days.
Time frame: Birth; assessed at 8-12 weeks postpartum.
Preterm Delivery
Was the baby born before 37 weeks gestational age, assessed as a yes/no outcome.
Time frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
Birth Weight
Birth weight of the infant, recorded in grams or lbs and oz
Time frame: Birth; assessed at 8-12 weeks postpartum.
Delivery Method
Was birth vaginal or by C-section; if C-section, emergent: yes/no
Time frame: Birth; assessed at 8-12 weeks postpartum.
Gestational Diabetes
Gestational diabetes diagnosed during pregnancy, assessed as a yes/no outcome.
Time frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
Gestational Hypertension
Gestational hypertension diagnosed during pregnancy, assessed as a yes/no outcome.
Time frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
Preeclampsia/Eclampsia
Pre-eclampsia or eclampsia diagnosed during pregnancy, assessed as a yes/no outcome.
Time frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
Maternal Postpartum Hemorrhage
Did maternal postpartum hemorrhage occur, assessed as a yes/no outcome.
Time frame: Birth; assessed at 8-12 weeks postpartum.
Apgar Scores
1-min and 5-min Apgar scores.
Time frame: Birth; assessed at 8-12 weeks postpartum.
Neonatal Intensive Care Unit (NICU) admission
Was the infant admitted to the NICU, assessed as a yes/no outcome; if yes, number of days in NICU and reason for admission
Time frame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Infant Death
Did the infant die before the age of one; assessed as a yes/no outcome.
Time frame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Neonatal Extrapyramidal Symptoms
Did movement dysfunction occur in the infant (such as dystonia, akathisia, parkinsonism characteristic symptoms such as rigidity, bradykinesia, tremor, and tardive dyskinesia); assessed as a yes/no outcome.
Time frame: Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Poor Neonatal Adaptation Syndrome (PNAS)
Did poor neonatal adaptation syndrome (PNAS) occur (including poor muscle tone, tremors, jitteriness, irritability, seizures, feeding difficulties, sleep disturbances, hypoglycemia, and respiratory distress); assessed as a yes/no outcome
Time frame: Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Child Development Outcomes - Ages and Stages Questionnaire (ASQ-3)
Were there developmental concerns, as assessed by the Ages and Stages Questionnaire (ASQ-3).
Time frame: Assessed at 9 months, year 3, and year 5.
Child Development Outcomes - Preschool Child Behavior Checklist (CBCL)
Were there developmental concerns, as assessed by the Preschool Child Behavior Checklist (CBCL).
Time frame: Assessed at 9 months, year 3, and year 5.
Breastfeeding
Did breastfeeding occur, assessed as a yes/no outcome; if yes, duration of breastfeeding recorded in weeks.
Time frame: Assessed at 8-12 weeks postpartum.