National Pregnancy Registry for Psychiatric Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Major Malformations in Infants
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women
- •Age 18-45
- •Subjects will be willing to participate over the phone
- •Subjects will be able to provide informed consent
排除标准
- •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
结局指标
主要结局
Major Malformations in Infants
时间窗: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
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.
次要结局
- Spontaneous Abortion (SAB)(Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.)
- Gestational Diabetes(Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.)
- Gestational Age(Birth; assessed at 8-12 weeks postpartum.)
- Maternal Gestational Weight Gain(Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.)
- Birth Weight(Birth; assessed at 8-12 weeks postpartum.)
- Neonatal Extrapyramidal Symptoms(Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.)
- Maternal Postpartum Hemorrhage(Birth; assessed at 8-12 weeks postpartum.)
- Preterm Delivery(Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.)
- Gestational Hypertension(Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.)
- Apgar Scores(Birth; assessed at 8-12 weeks postpartum.)
- Child Development Outcomes - Ages and Stages Questionnaire (ASQ-3)(Assessed at 9 months, year 3, and year 5.)
- Child Development Outcomes - Preschool Child Behavior Checklist (CBCL)(Assessed at 9 months, year 3, and year 5.)
- Breastfeeding(Assessed at 8-12 weeks postpartum.)
- Intrauterine Fetal Demise (IUFD)(Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.)
- Delivery Method(Birth; assessed at 8-12 weeks postpartum.)
- Preeclampsia/Eclampsia(Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.)
- Neonatal Intensive Care Unit (NICU) admission(Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.)
- Live Birth(Birth; assessed at 8-12 weeks postpartum.)
- Infant Death(Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.)
- Poor Neonatal Adaptation Syndrome (PNAS)(Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.)
研究者
Lee S. Cohen, MD
Director, MGH Center for Women's Mental Health
Massachusetts General Hospital