National Pregnancy Registry for Psychiatric Medications

Pregnant Women Clinical Trial

Official title:

National Pregnancy Registry for Psychiatric Medications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01246765
• Other study ID #: 2008P-001861
• Status: Recruiting
• Start date: November 2008
• Est. completion date: December 2033

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: Bryn Rediger
• Phone: (617) 724-8020
• Email: brediger[@]partners.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2033
• Est. primary completion date: December 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women
• Psychotropic Drugs

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Alkermes, Inc., Eisai Inc., Janssen Pharmaceuticals, Otsuka America Pharmaceutical, Sage Therapeutics, Supernus Pharmaceuticals, Inc., Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohen LS, Viguera AC, McInerney KA, Freeman MP, Sosinsky AZ, Moustafa D, Marfurt SP, Kwiatkowski MA, Murphy SK, Farrell AM, Chitayat D, Hernandez-Diaz S. Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Am J Psychiatry. 2016 Mar 1;173(3):263-70. doi: 10.1176/appi.ajp.2015.15040506. Epub 2015 Oct 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Live Birth	Did the pregnancy end in a live birth, assessed as a yes/no outcome.	Birth; assessed at 8-12 weeks postpartum.
Secondary	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.
Secondary	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.
Secondary	Gestational Age	The gestational age of the infant at birth, recorded in weeks and days.	Birth; assessed at 8-12 weeks postpartum.
Secondary	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.
Secondary	Birth Weight	Birth weight of the infant, recorded in grams or lbs and oz	Birth; assessed at 8-12 weeks postpartum.
Secondary	Delivery Method	Was birth vaginal or by C-section; if C-section, emergent: yes/no	Birth; assessed at 8-12 weeks postpartum.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Maternal Postpartum Hemorrhage	Did maternal postpartum hemorrhage occur, assessed as a yes/no outcome.	Birth; assessed at 8-12 weeks postpartum.
Secondary	Apgar Scores	1-min and 5-min Apgar scores.	Birth; assessed at 8-12 weeks postpartum.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Breastfeeding	Did breastfeeding occur, assessed as a yes/no outcome; if yes, duration of breastfeeding recorded in weeks.	Assessed at 8-12 weeks postpartum.

External Links

•   National Pregnancy Registry for Atypical Antipsychotics Website