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Study Title and Description

Triptan safety during pregnancy: a Norwegian population registry study.



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 Triptan safety during pregnancy: a Norwegian population registry study.
Author Nezvalov√°-Henriksen K., Spigset O., Nordeng H.
Country Department of Pharmacy, School of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, P.O. Box 1065, Blindern, 0316, Oslo, Norway, katerina.nezvalova-henriksen@farmasi.uio.no.
Year 2013
Numbers Pubmed ID: 23884894

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction form for Direct Evidence (Primary Studies)
Arms
Number Title Description Comments
1 Triptans: Any
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2 Triptans: Sumatriptan
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3 Triptans: Rizatriptan
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4 Triptans: Eletriptan
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5 Triptans: Zolmitriptan
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6 Triptans: Any (before pregnancy only)
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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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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? Multiple regression
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What was the DIRECTIONALITY of the study? Retrospective
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In what COUNTRY was the study done? ... Other, specify ... Norway
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What was the FUNDING SOURCE of the study? ... Can't tell/Not reported ...
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Does the study have a NAME or ACRONYM? ... Yes, specify... ... Norwegian Prescription Database (NorPD)
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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? 2004
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2007
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What were the study INCLUSION criteria? Women with migraine
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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: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 1465 NR NR NR NR 1095 2560
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What were the RACE/ETHNICITY of the women in the study? Not reported Not reported Not reported 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 Not reported Not reported Not reported
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What was the AGE DISTRIBUTION of the women in the study? (CATEGORICAL data) <=20 years <=20 years
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2.4 3.4
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21-25 years 21-25 years
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12.6 14.0
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26-30 years 26-30 years
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31.9 33.6
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31-35 years 31-35 years
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36.2 34.2
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36-40 years 36-40 years
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14.1 13.1
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41-45 years 41-45 years
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2.7 0.7
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>45 years >45 years
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0.1 0.1
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In what PHASE were the women in the study? 1st trimester...% NR 1st trimester...% NR 1st trimester...% NR 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 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 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 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 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 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 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 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 - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1465 575 334 207 156 1095
Counts 85 35 15 8 12 67
Percentage 5.7 6.1 4.5 3.9 7.7 6.1
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1210 415 310 189 144 1095
Counts 72 28 14 8 11 67
Percentage 6.0 6.7 4.5 4.2 7.6 6.1
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1465 575 334 207 156 1095
Counts 51 19 11 4 8 50
Percentage 3.5 3.3 3.3 1.9 5.1 4.6
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1210 415 310 189 144 1095
Counts 43 15 10 4 7 50
Percentage 3.6 3.6 3.2 2.1 4.9 4.6
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: All Participants
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1465 575 334 207 156 1095
Counts 75 31 16 7 11 66
Percentage 5.1 5.4 4.8 3.4 7.1 6.0
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1210 415 310 189 144 1095
Counts 61 23 15 6 9 66
Percentage 5.0 5.5 4.8 3.2 6.2 6.0
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: 2nd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 304 173 43 33 26 1095
Counts 22 11 1 3 4 66
Percentage 7.2 6.4 2.3 9.1 15.4 6.0
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: 3rd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 185 104 26 21 17 1095
Counts 8 3 3 0 1 66
Percentage 4.3 2.9 11.5 0.0 5.9 6.0
Outcome: Adverse events - Fetal/Infant - Preterm birth      Population: All Participants
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1465 575 334 207 156 1095
Counts 92 41 18 9 14 108
Percentage 6.3 7.1 5.4 4.3 9.0 9.9
Outcome: Adverse events - Fetal/Infant - Preterm birth      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1210 415 310 189 144 1095
Counts 76 32 17 7 13 108
Percentage 6,3 7.7 5.5 3.7 9.0 9.9
Outcome: Adverse events - Fetal/Infant - Preterm birth      Population: 2nd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 304 173 43 33 26 1095
Counts 27 11 6 3 5 108
Percentage 8.9 6.4 14.0 9.1 19.2 9.9
Outcome: Adverse events - Fetal/Infant - Preterm birth      Population: 3rd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 185 104 26 21 17 1095
Counts 12 7 2 1 0 108
Percentage 6.5 6.7 7.7 4.8 0.0 9.9
Outcome: Adverse events - Fetal/Infant - Low birth weight for gestational age      Population: All Participants
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1465 575 334 207 156 1095
Counts 132 48 36 21 13 91
Percentage 9.0 8.3 10.8 10.1 8.3 8.3
Outcome: Adverse events - Fetal/Infant - Low birth weight for gestational age      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1210 415 310 189 144 1095
Counts 110 33 36 20 13 91
Percentage 9.1 8.0 11.6 10.6 9.0 8.3
Outcome: Adverse events - Fetal/Infant - Low birth weight for gestational age      Population: 2nd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 304 173 43 33 26 1095
Counts 27 16 2 4 2 91
Percentage 8.9 9.2 4.7 12.1 7.7 8.3
Outcome: Adverse events - Fetal/Infant - Low birth weight for gestational age      Population: 3rd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 185 104 26 21 17 1095
Counts 20 11 4 1 1 91
Percentage 10.8 10.6 15.4 4.8 5.9 8.3
Outcome: Adverse events - Fetal/Infant - Other      Population: All Participants
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1095
Counts 120
Percentage 11.0
Outcome: Adverse events - Fetal/Infant - Other      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1210 415 310 189 144 1095
Counts 100 41 23 15 12 120
Percentage 8.3 9.9 7.4 7.9 8.3 11.0
Outcome: Adverse events - Fetal/Infant - Other      Population: 2nd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 304 173 43 33 26 1095
Counts 31 14 5 4 4 120
Percentage 10.2 8.1 11.6 12.1 15.4 11.0
Outcome: Adverse events - Fetal/Infant - Other      Population: 3rd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 185 104 26 21 17 1095
Counts 16 5 4 1 4 120
Percentage 8.6 4.8 15.4 4.8 23.5 11.0
Outcome: Adverse events - Maternal - Other      Population: All Participants
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1465 575 334 207 156 1095
Counts 248 100 49 30 34 195
Percentage 16.9 17.4 14.7 14.5 21.8 17.8
Outcome: Adverse events - Maternal - Other      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 1210 415 310 189 144 1095
Counts 204 71 45 29 33 195
Percentage 16.9 17.1 14.5 15.3 22.9 17.8
Outcome: Adverse events - Maternal - Other      Population: 2nd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 304 173 43 33 26 1095
Counts 65 40 9 4 6 195
Percentage 21.4 23.1 20.9 12.1 23.1 17.8
Outcome: Adverse events - Maternal - Other      Population: 3rd trimester
Time Point Measure Triptans: Any Triptans: Sumatriptan Triptans: Rizatriptan Triptans: Eletriptan Triptans: Zolmitriptan Triptans: Any (before pregnancy only)


Delivery N/A

N Analyzed 185 104 26 21 17 1095
Counts 24 11 5 2 2 195
Percentage 13.0 10.6 19.2 9.5 11.8 17.8


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? Yes
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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? Yes
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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 Low
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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
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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. High
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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. Low
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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 No data about doses, etc.
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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
No quality rating data was found.