National Pregnancy Registry for Psychiatric Medications

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics. To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy. To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.

Official Title
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National Pregnancy Registry for Psychiatric Medications

Conditions
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Pregnant Women, Psychotropic Drugs

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women Age 18-45 Subjects will be willing to participate over the phone Subjects will be able to provide informed consent Exclusion Criteria: Women who have completed their pregnancy Women who are planning to become pregnant Women who are not taking any psychiatric medications and/or have no history of psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atypical Antipsychotic Cohort<br>Pregnant women who have taken at least one type of atypical antipsychotic at some point during pregnancy. Medications of Special Interest: Abilify (aripiprazole) Aristada (aripiprazole lauroxil) Aristada Initio (aripiprazole lauroxil) Clozaril (clozapine) Lybalvi (olanzapine and samidorphan) Rexulti (brexpiprazole) Risperdal (risperidone) Seroquel (quetiapine) Symbax (olanzapine-fluoxetine HCL) Zyprexa (olanzapine) | |
| Antidepressant Medications<br>Pregnant women who have taken at least one type of antidepressant medication at some point during pregnancy. Medications of Special Interest: Spravato (esketamine) Zulresso (brexanolone) | |
| ADHD Medications<br>Pregnant women who have taken at least one type of ADHD medication at some point during pregnancy. Medications of Special Interest: • Qelbree (viloxazine) | |
| Sedative Hypnotic Medications<br>Pregnant women who have taken at least one type of sedative hypnotic medication at some point during pregnancy. Medications of Special Interest: • Dayvigo (lemborexant) | |
| Other Psychiatric Medications<br>Pregnant women who have taken other psychiatric medications (other than atypical antipsychotics, ADHD medications, antidepressants, or sedative hypnotics) at some point during pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major 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. | Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum. | 
| Gestational Age | The gestational age of the infant at birth, recorded in weeks and days. | Birth; assessed at 8-12 weeks postpartum. | 
| Preterm Delivery | Was the baby born before 37 weeks gestational age, assessed as a yes/no outcome. | 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 | Birth; assessed at 8-12 weeks postpartum. | 
| Delivery Method | Was birth vaginal or by C-section; if C-section, emergent: yes/no | Birth; assessed at 8-12 weeks postpartum. | 
| Gestational Diabetes | Gestational diabetes diagnosed during pregnancy, assessed as a yes/no outcome. | 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. | 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. | 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. | Birth; assessed at 8-12 weeks postpartum. | 
| Apgar Scores | 1-min and 5-min Apgar scores. | 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 | 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. | 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. | 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 | 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). | 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). | 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. | Assessed at 8-12 weeks postpartum. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Medication use during pregnancy, Psychiatric medications, ADHD, Atypical Antipsychotics, Antidepressants, Sedative Hypnotics