Studies On Safe Drugs During Pregnancy

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This dataset contains a list of the current Pregnancy Registries in research in the United States, their status and contact information. Pregnancy exposure registries are observational studies that focus on the outcome of pregnancies of women with medical conditions that require taking medications, they observe if birth defects are shown, acting as postmarketing surveillance, although women are enrolled in the study before the outcome is known.

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Complexity

These registries can be performed by the FDA (Food and Drug Administration) or by independent organizations and reported to the FDA. This dataset is a list of the reported pregnancy registries in development, containing the drug studied, women’s medical condition, contact information and status of the research project. “Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy. FDA does not conduct any pregnancy registries. The registries on this dataset are posted based on a sponsor or investigator’s request to list their registry. FDA does not endorse any registry and is not responsible for the content of registries listed on this dataset. This dataset may not represent a comprehensive list of pregnancy exposure registries.

Date Created

2016-03-30

Last Modified

2020-04-01

Version

2020-04-01

Update Frequency

Irregular

Temporal Coverage

2020

Spatial Coverage

United States

Source

John Snow Labs; US Food and Drug Administration;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

During Pregnancy, Drugs in Pregnancy and Lactation, Drugs in Pregnancy, Pregnancy Medicine, Safe Medications During Pregnancy, FDA Pregnancy

Other Titles

List of Pregnancy Registries, Current Observational Studies on Pregnancy Drug Exposure, Pregnancy Registries in the US

NameDescriptionTypeConstraints
MedicineDrugs that are being observed in the studystring-
Medical_ConditionDisease(s) of the patients included in the registry.string-
RegistryName of the registry.string-
HospitalHospital/Organization Name for the registrystring-
Website_URLContact information for the registry (Website URL)string-
Phone_NumberContact information for the registry (Phone Number)string-
StatusEnrollment stage of the registry.string-
MedicineMedical ConditionRegistryHospitalWebsite URLPhone NumberStatus
Abilify (aripiprazole)Mental Health DisordersNational Pregnancy Registry for Atypical AntipsychoticsCenter for Women’s Mental Health at Massachusetts General Hospitalwww.womensmentalhealth.org1-866-961-2388Ongoingopened
acitretinPsoriasisT.A.P.P. (Take Action to Prevent Pregnancy)Pregnancy Monitoring Program for acitretin PPD, Inc.http://www.tevagenerics.com/acitretin1-855-850-2138Ongoingopened
Actemra (tocilizumab)Any approved indication or indication currently in Phase III TrialsOTIS Autoimmune Diseases in Pregnancy StudyMotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS)https://mothertobaby.org/ongoing-study/actemra/1-877-311-8972Ongoingopened
Adderall (Amphetamine)ADD/ADHDNational Pregnancy Registry for PsychostimulantsCenter for Women’s Mental Health at Massachusetts General Hospitalhttps://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/othermedications/1-866-961-2388Ongoing
Afluria QuadrivalentInfluenza VaccineSeqirus Influenza Vaccine Pregnancy Registryus.medicalinformation@seqirus.com1-855-358-8966Ongoing
Afluria VaccineInfluenza VaccineOTIS Vaccines and Medication in Pregnancy Surveillance StudyMotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS)http://mothertobaby.org/ongoing-studies/1-877-311-8972Enrolled Completed
Aldurazyme (laronidase)MPS I Mucopolysaccharidosis I Hurler's Syndrome Scheie's Syndrome Hurler-Scheie SyndromeMPSI RegistryGenzyme Corporationwww.registrynxt.com1-800-633-1610Ongoingopened
Anafranil (clomipramine)DepressionNational Pregnancy Registry for AntidepressantsCenter for Women's Healthhttps://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/1-844-405-6185Ongoingopened
Aptiom (eslicarbazepine) (acetate)antiepileptic drugAntiepileptic Drug Pregnancy RegistryMassachusetts General Hospitalhttp://www.aedpregnancyregistry.org/1-888-233-2334Ongoingopened
Arava (leflunomide)Rheumatoid ArthritisLeflunomide Pregnancy Registry OTIS Autoimmune Diseases in Pregnancy StudyMotherToBaby: Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS)https://mothertobaby.org/ongoing- study/arava/1-877-311-8972Ongoingopened
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