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Sumatriptan and Naratriptan Pregnancy Registry

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: January 28, 2010
Last updated: October 30, 2014
Last verified: October 2014
Anti-migraine drugs, including triptans, are not indicated for use in pregnancy. However, the peak prevalence of migraine is in women of childbearing age. This, coupled with the sporadic nature of migraine attacks and high rates of unplanned pregnancies, makes unintentional exposure to anti-migraine medications during pregnancy likely. Prior to an anti-migraine medication being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The Sumatriptan Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1996 to monitor the safety of sumatriptan during pregnancy. It was combined with the Naratriptan Pregnancy Registry in 2001 and data collection on the sumatriptan-naproxen combination (Treximet) began in 2008.

Condition Intervention
Migraine Disorders
Drug: Sumatriptan
Drug: Naratriptan
Drug: Sumatriptan-naproxen combination

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Years
Official Title: The Sumatriptan and Naratriptan Pregnancy Registry

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Major congenital malformations (MCMs) classified according to the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) criteria. [ Time Frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth. ]

Enrollment: 868
Study Start Date: December 2001
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant women exposed to sumatriptan, naratriptan, or combo
Women exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination treatment during pregnancy
Drug: Sumatriptan
Drug: Naratriptan
Drug: Sumatriptan-naproxen combination
Sumatriptan-naproxen combination

  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination during pregnancy anywhere in the world.

Inclusion Criteria:

  • Women exposed in utero to sumatriptan, naratriptan or the sumatriptanp-naproxen combination during pregnancy. Exposure can occur at any time during pregnancy, though exposure in the first trimester is of primary interest.
  • Pregnancies exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination and reported before the outcome of the pregnancy is known (prospective reporting). Ideally exposed pregnancies are registered prior to prenatal testing, but only those pregnancies enrolled after prenatal testing has diagnosed a congenital malforamtion are excluded.
  • Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are considered descriptively and are not included in risk analyses.

Exclusion Criteria:

  • Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are reviewed separately and descriptively. These are not included in risk analyses.
  • Patient reported exposures and outcomes that are not verified by a healthcare provider.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01059604

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01059604     History of Changes
Other Study ID Numbers: 112914
EPIP082 ( Other Identifier: GSK )
EPI40050 ( Other Identifier: GSK )
Study First Received: January 28, 2010
Last Updated: October 30, 2014

Keywords provided by GlaxoSmithKline:
pregnancy outcomes
first trimester
major congenital malformations
sumatriptan-naproxen combination
pregnancy registry

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents processed this record on May 25, 2017