Last updated: 11/03/2018 13:49:50
Sumatriptan and Naratriptan Pregnancy Registry
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: The Sumatriptan and Naratriptan Pregnancy Registry
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Major congenital malformations (MCMs) classified according to the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) criteria.
Timeframe: 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.
Secondary outcomes:
Not applicable
Interventions:
Drug: Sumatriptan
Drug: Naratriptan
Drug: Sumatriptan-naproxen combination
Enrollment:
868
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Cunnington M. C., Ephross S.A., Churchill P. The safety of sumatriptan during pregnancy: what have we learned? Heachache. 2009. 49: 1414-1422.
Eldridge RR, Ephross SA, Heffner CR, Tennis PS, Stender MD, 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; 5(4): 190-191.
Reiff-Eldridge RR, 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 Gynaecol. 2000; 182 (1 Pt 1): 159-63.
Eldridge RR, Ephross SA. Monitoring birth outcomes in the sumatriptan pregnancy registry. Prim Care Update Ob Gyns. 1998; 5(4): 190.
Sumatriptan and Naratriptan Pregnancy Registry. Interim Report 1 January 1996 through 31 October 2009. Issued February 2010. Available at: http://pregnancyregistry.gsk.com/index.html
S. Ephross and S Roberts.Final Results from the 16-year Sumatriptan, Naratriptan, and Treximet Pregnancy Registry.Headache.2014;54(7):1158-1172
Medical condition
Migraine Disorders
Product
naproxen, naratriptan, sumatriptan, sumatriptan/naproxen
Collaborators
Not applicable
Study date(s)
December 2001 to April 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
No
- 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 reviewed separately and descriptively. These are not included in risk analyses.
- Patient reported exposures and outcomes that are not verified by a healthcare provider.
Inclusion and exclusion criteria
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.
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2013-24-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
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Additional information
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