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Study Title and Description

Topiramate monotherapy use in women with and without epilepsy: pregnancy and neonatal outcomes.



Key Questions Addressed
1 Direct Evidence (Primary Studies): KQ 1 - What are the (comparative) benefits and harms of interventions to prevent 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 Topiramate monotherapy use in women with and without epilepsy: pregnancy and neonatal outcomes.
Author Castilla-Puentes R., Ford L., Manera L., Kwarta RF., Ascher S., Li Q.
Country Janssen Research & Development, LLC, NJ, USA. Electronic address: rcastil4@its.jnj.com.
Year 2014
Numbers Pubmed ID: 24598456

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 Antiepileptics: Topiramate
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Design Details
Question... Follow Up Answer Follow-up Answer
Which KEY QUESTION (KQ) does this study address? KQ 1: Prevention of primary headache
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What is the STUDY DESIGN? Single group study....Skip to Question 4
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What was the DIRECTIONALITY of the study? Retrospective
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In what COUNTRY was the study done? US
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UK
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Australia
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Other, specify ... 36 other countries
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Canada
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What was the FUNDING SOURCE of the study? ... Industry, specify name(s) of company... ... Janssen Research & Development, LLC (previously known as Johnson & Johnson Pharmaceutical Research & Development L.L.C)
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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? 1995
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2011
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What were the study INCLUSION criteria? Pregnant women treated for 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? This was a registry study (Janssen's Global Medical Safety (GMS) database)
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Baseline Characteristics
Question Antiepileptics: Topiramate Total Comments
AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 81 81
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What were the RACE/ETHNICITY of the women in the study? 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
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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...%
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What was the GESTATIONAL AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) 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
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What was the PARITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported
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What were the TYPES of PRIMARY HEADACHE in the women in the study? Migraine...% Migraine...%
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What percentage of the women in the study had a HISTORY OF PRIMARY HEADACHE? 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 Antiepileptics: Topiramate


Not reported N/A

N Analyzed 81
Counts 23
Percentage 28.4
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 81
Counts 10
Percentage 12.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 81
Counts 2
Percentage 2.5
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 240
Counts 1
Percentage 0.4
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 81
Counts 1
Percentage 1.2
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 81
Counts 1
Percentage 1.2
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 81
Counts 1
Percentage 1.2
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 81
Counts 1
Percentage 1.2
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 81
Counts 1
Percentage 1.2
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Delivery N/A

N Analyzed 81
Counts 1
Percentage 1.2
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Unclear N/A

N Analyzed 81
Counts 10
Percentage 12.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Antiepileptics: Topiramate


Unclear N/A

N Analyzed 81
Counts 1
Percentage 1.2


Quality Dimensions
Dimension Value Notes Comments
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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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?
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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?
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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?
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Q6: Risk of bias judgement for BIAS DUE TO CONFOUNDING
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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?
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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?
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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?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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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?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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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
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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.
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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.
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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.
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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 Data
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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.