National Pregnancy Registry for Psychiatric Medications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women
Age 18-45
Subjects will be willing to participate over the phone
Subjects will be able to provide informed consent
Disqualifiers
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
Trial population
Pregnant women from across the United States will be enrolled in this registry.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 5 trial groupsGroup A: Atypical Antipsychotic Cohort
Group B: Antidepressant Medications
Group C: ADHD Medications
Group D: Sedative Hypnotic Medications
Group E: Other Psychiatric Medications
Trial outcomes
Primary outcomes
1
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.
Time frame
Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Alkermes, Inc.
Collaborator
Eisai Inc.
Collaborator
Otsuka America Pharmaceutical
Collaborator
Supernus Pharmaceuticals, Inc.
Collaborator
Sage Therapeutics
Collaborator
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov