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Study Title and Description

Pregnancy outcome following prescription for sumatriptan.



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 Pregnancy outcome following prescription for sumatriptan.
Author Olesen C., Steffensen FH., Sorensen HT., Nielsen GL., Olsen J.
Country Danish Epidemiology Science Centre at the Department of Epidemiology and Social Medicine, University of Aarhus, Aarhus C.
Year 2000
Numbers Pubmed ID: 10759898

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: Sumatriptan
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2 Triptans: Sumatriptan or Ergot Products: Ergotamine (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 ... Denmark
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What was the FUNDING SOURCE of the study? ... Industry, specify name(s) of company... ... Helsefonden, Pharmacy Foundation
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Non-industry, specify name(s) of agency... ... EU BIOMED Programme, Danish Medical Research Council, North Jutland Research Council
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Does the study have a NAME or ACRONYM? ... Yes, specify... ... Pharmaco-Epidemiological Prescription Database of North Jutland County
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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? 1991
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1996
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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: Sumatriptan Triptans: Sumatriptan or Ergot Products: Ergotamine (before pregnancy only) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 34 89 123
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What were the RACE/ETHNICITY of the women in the study? Not reported Not reported Not reported
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What was the AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Mean 29.6 Mean 28.4 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? Not reported...% Not reported...% Not reported...%
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What was the GESTATIONAL AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) 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
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What was the PARITY DISTRIBUTION of the women in the study? (CONTINUOUS data) 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
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What percentage of the women in the study had a HISTORY OF PRIMARY HEADACHE? 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
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Sumatriptan Triptans: Sumatriptan or Ergot Products: Ergotamine (before pregnancy only) Comparison Measure Triptans: Sumatriptan vs. Triptans: Sumatriptan or Ergot Products: Ergotamine (before pregnancy only)


Delivery N/A

N Analyzed 34 89 0.9
Counts 1 5 0.1
Percentage 3.4 5.8 11.8
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Adverse events - Fetal/Infant - Preterm birth      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Sumatriptan Triptans: Sumatriptan or Ergot Products: Ergotamine (before pregnancy only) Comparison Measure Triptans: Sumatriptan vs. Triptans: Sumatriptan or Ergot Products: Ergotamine (before pregnancy only)


<37 weeks

N Analyzed 34 89 6.3
Counts 5 3 1.2
Percentage 14.7 3.4 32.0


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? 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? Yes
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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. 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 description of dose, 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.