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Study Title and Description

Pregnancy and perinatal outcomes in migraineurs using sumatriptan: a prospective 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 Pregnancy and perinatal outcomes in migraineurs using sumatriptan: a prospective study.
Author O'Quinn S., Ephross SA., Williams V., Davis RL., Gutterman DL., Fox AW.
Country US Medical Affairs, Glaxo Wellcome Research Institute, Research Triangle Park, NC 27709, USA.
Year 1999
Numbers Pubmed ID: 10728620

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 (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? None
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What was the DIRECTIONALITY of the study? Prospective
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In what COUNTRY was the study done? US
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What was the FUNDING SOURCE of the study? ... Industry, specify name(s) of company... ... Glaxo Wellcome Research Unit
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Does the study have a NAME or ACRONYM? No/not reported
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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? NR
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NR
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What were the study INCLUSION criteria? Pregnant 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 (before pregnancy only) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 76 92 168
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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) 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? 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
Outcome: Adverse events - Maternal - Other      Population: All Participants
Time Point Measure Triptans: Sumatriptan Triptans: Sumatriptan (before pregnancy only)


Delivery N/A

N Analyzed 76 92
Counts 9 19
Percentage 12 21
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Triptans: Sumatriptan Triptans: Sumatriptan (before pregnancy only)


Not reported N/A

N Analyzed 76 92
Counts 8 11
Percentage 10.5 12


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? No
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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? No
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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? No
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY Serious
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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. Unclear
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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 Unclear
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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? No
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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? No
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Quality Rating
Guideline Used Overall Rating