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Study Title and Description

Final results from the 16-year sumatriptan, naratriptan, and treximet pregnancy registry.



Key Questions Addressed
2 Direct Evidence (Primary Studies): KQ 2 - What are the (comparative) benefits and harms of interventions to treat acute attacks of primary headache in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding?
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Primary Publication Information
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TitleData
Title Final results from the 16-year sumatriptan, naratriptan, and treximet pregnancy registry.
Author Ephross SA., Sinclair SM.
Country Worldwide Epidemiology, GlaxoSmithKline, Research Triangle Park, NC, USA.
Year 2014
Numbers Pubmed ID: 24805878

Secondary Publication Information
UI Title Author Country Year
The safety of sumatriptan and naratriptan in pregnancy: what have we learned? Cunnington M., Ephross S., Churchill P. GlaxoSmithKline-Worldwide Epidemiology, New Frontiers Park, South 3rd Avenue, Harlow, Essex, UK. -- Not Found --
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https://ClinicalTrials.gov/show/NCT01059604 2014
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Extraction Form: Extraction form for Direct Evidence (Primary Studies)
Arms
Number Title Description Comments
1 Triptans: Sumatriptan
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2 Triptans: Naratriptan
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3 Combination of Triptans: Sumatriptan and NSAIDs: Naproxen
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Design Details
Question... Follow Up Answer Follow-up Answer
Which KEY QUESTION (KQ) does this study address? KQ2: Treatment of primary headache
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KQ2: Treatment of primary headache
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KQ2: Treatment of primary headache
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KQ2: Treatment of primary headache
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What is the STUDY DESIGN? Nonrandomized comparative study (NRCS)
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What was the ANALYTIC METHOD used to control for differences between study groups? None
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What was the DIRECTIONALITY of the study? Prospective
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In what COUNTRY was the study done? ... Other, specify ... 16 other countries
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US
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UK
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What was the FUNDING SOURCE of the study? ... Industry, specify name(s) of company... ... GlaxoSmithKline
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Does the study have a NAME or ACRONYM? ... Yes, specify... ... Sumatriptan, Naratriptan, and Treximet Pregnancy Registry
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Does the study have a CLINICALTRIALS.GOV IDENTIFICATION NUMBER? No/not reported
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What were the START and END YEARS of the study? 1996
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2012
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What were the study INCLUSION criteria? pregnant, exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen sodium combination product at any time during pregnancy
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What were the study EXCLUSION criteria? NR
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Do you have any NOTES regarding the design or any overall aspects of this study?
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Baseline Characteristics
Question Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 626 57 6 689
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What were the RACE/ETHNICITY of the women in the study? Not reported Not reported Not reported Not reported
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What was the AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported Not reported Not reported
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What was the AGE DISTRIBUTION of the women in the study? (CATEGORICAL data) No data entered.
In what PHASE were the women in the study? 1st trimester...% NR 1st trimester...% NR 1st trimester...% NR 1st trimester...% NR
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2nd trimester...% NR 2nd trimester...% NR 2nd trimester...% NR 2nd trimester...% NR
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3rd trimester...% NR 3rd trimester...% NR 3rd trimester...% NR 3rd trimester...% NR
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What was the GESTATIONAL AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported Not reported Not reported
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What was the UNIT for the gestational age you answered in the previous question? No data entered.
What was the GRAVIDITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported Not reported Not reported
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What was the PARITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported Not reported Not reported
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What were the TYPES of PRIMARY HEADACHE in the women in the study? Migraine...% 100 Migraine...% 100 Migraine...% 100 Migraine...% 100
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What percentage of the women in the study had a HISTORY OF PRIMARY HEADACHE? Not reported Not reported Not reported Not reported
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Do you have any NOTES regarding the baseline characteristics in this study? No data entered.



Results & Comparisons


Results Data
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Not reported N/A

N Analyzed 626 57 6
Counts 34 5 1
Percentage 5.4 8.8 16.7
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 1st trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Not reported N/A

N Analyzed 528 52 5
Counts 34 5 1
Percentage 6.4 9.6 20.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 2nd trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Not reported N/A

N Analyzed 78 5 1
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 3rd trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Not reported N/A

N Analyzed 16 0 0
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: Unknown trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Not reported N/A

N Analyzed 4 0 0
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 626 57 6
Counts 19 1 0
Percentage 3.0 1.8 0.0
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 528 52 5
Counts 16 1 0
Percentage 3.0 1.9 0.0
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 2nd trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 78 5 1
Counts 3 0 0
Percentage 3.8 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 3rd trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 16 0 0
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: Unknown trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 4 0 0
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 626 57 6
Counts 16 1 0
Percentage 2.6 1.8 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 1st trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 528 52 5
Counts 15 1 0
Percentage 2.8 1.9 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 2nd trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 78 5 1
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 3rd trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 16 0 0
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: Unknown trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 4 0 0
Counts 1 0 0
Percentage 25.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 626 57 6
Counts 5 0 0
Percentage 0.8 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 1st trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 528 52 5
Counts 5 0 0
Percentage 1.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 2nd trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 78 5 1
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 3rd trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 16 0 0
Counts 0 0 0
Percentage 0.0 0.0 0.0
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: Unknown trimester
Time Point Measure Triptans: Sumatriptan Triptans: Naratriptan Combination of Triptans: Sumatriptan and NSAIDs: Naproxen


Delivery N/A

N Analyzed 4 0 0
Counts 0 0 0
Percentage 0.0 0.0 0.0


Quality Dimensions
Dimension Value Notes Comments
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? Yes
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Q2: Did the study divide the follow up time of each individual participant into the different interventions? No
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? No
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study? No
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? No
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Q6: Risk of bias judgement for BIAS DUE TO CONFOUNDING Serious
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention? No
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention? Not Applicable
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome? Not Applicable
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? Yes
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Q11: Did the start and follow up calendar years coincide for most participants in the study? No Data
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases? Not Applicable
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY Low
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Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. High
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. High
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Not Applicable
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes.
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? No
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
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Quality Rating
Guideline Used Overall Rating