National Pregnancy Registry for Atypical Antipsychotics
The purpose of the National Pregnancy Registry for Atypical Antipsychotics is to determine the frequency of birth defects among infants exposed to atypical antipsychotics.
Use of Atypical Antipsychotics During Pregnancy
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:||15 Months|
|Official Title:||National Pregnancy Registry for Atypical Antipsychotics|
- Rate of major malformations in infants exposed to atypical antipsychotics during the first trimester of pregnancy [ Time Frame: Birth to six months old ] [ Designated as safety issue: Yes ]The primary outcome for this study is rates of major malformations in infants exposed in utero to atypical antipsychotics during the first trimester of pregnancy. This data is collected through pediatric medical record review through the first six months of infants' lives.
- Maternal health outcomes [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]Maternal health outcomes during pregnancy will also be assessed in women taking atypical antipsychotics during pregnancy (for example: weight gain, gestational hypertension, gestational diabetes, preeclampsia)
- Neonatal health outcomes [ Time Frame: Birth to six months old ] [ Designated as safety issue: Yes ]Other neonatal health outcomes will also be assessed in infants exposed in utero to atypical antipsychotics (for example: birth weight/length, Apgar scores, NICU admission rates, and any other neonatal complications). Presence of extrapyramidal symptoms from birth to one month old will also be assessed in infants exposed to atypical antipsychotics proximate to delivery.
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Pregnant women using atypical antipsychotic(s)
Pregnant women who have taken at least one type of atypical antipsychotic at some point during this pregnancy.
Pregnant women not using atypical antipsychotics
Pregnant women who have not taken an atypical antipsychotic during pregnancy.
The National Pregnancy Registry for Atypical Antipsychotics is dedicated to evaluating the safety of atypical antipsychotic medications that may be taken by women during pregnancy to treat a wide range of mood, anxiety, or psychiatric disorders. The primary goal of this Registry is to determine the frequency of major malformations, such as heart defects, cleft lip, or neural tube defects, in infants exposed to atypical antipsychotics during pregnancy. We are currently studying the following medications:
- Abilify (aripiprazole)
- Clozaril (clozapine)
- Geodon (ziprasidone)
- Invega (paliperidone)
- Risperdal (risperidone)
- Seroquel (quetiapine)
- Zyprexa (olanzapine)
- Saphris (asenapine)
- Fanapt (iloperidone)
- Latuda (lurasidone)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246765
|Contact: Alexandra Sosinsky, BSfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Lee S Cohen, MD|
|Principal Investigator:||Lee S Cohen, MD||Massachusetts General Hospital|