Sumatriptan and Naratriptan Pregnancy Registry
The Sumatriptan and Naratriptan Pregnancy Registry
3 other identifiers
observational
868
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2001
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 28, 2010
CompletedFirst Posted
Study publicly available on registry
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 3, 2014
October 1, 2014
11.3 years
January 28, 2010
October 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major congenital malformations (MCMs) classified according to the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) criteria.
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.
Study Arms (1)
Pregnant women exposed to sumatriptan, naratriptan, or combo
Women exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination treatment during pregnancy
Interventions
Sumatriptan-naproxen combination
Eligibility Criteria
Women exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination during pregnancy anywhere in the world.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (5)
Cunnington M, Ephross S, Churchill P. The safety of sumatriptan and naratriptan in pregnancy: what have we learned? Headache. 2009 Nov-Dec;49(10):1414-22. doi: 10.1111/j.1526-4610.2009.01529.x. Epub 2009 Oct 5.
PMID: 19804390BACKGROUNDEldridge RR, Ephross SA, Heffner CR, Tennis PS, Stender DM, White AD. Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment. Prim Care Update Ob Gyns. 1998 Jul 1;5(4):190-191. doi: 10.1016/s1068-607x(98)00115-2.
PMID: 10838360BACKGROUNDReiff-Eldridge R, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynecol. 2000 Jan;182(1 Pt 1):159-63. doi: 10.1016/s0002-9378(00)70506-0.
PMID: 10649172BACKGROUNDEldridge RR, Ephross SA. Monitoring birth outcomes in the Sumatriptan Pregnancy Registry. Prim Care Update Ob Gyns. 1998 Jul 1;5(4):190. doi: 10.1016/s1068-607x(98)00114-0.
PMID: 10838359BACKGROUNDSumatriptan and Naratriptan Pregnancy Registry. Interim Report 1 January 1996 through 31 October 2009. Issued February 2010. Available at: http://pregnancyregistry.gsk.com/index.html
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2010
First Posted
February 1, 2010
Study Start
December 1, 2001
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 3, 2014
Record last verified: 2014-10