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Study Title and Description

Triptan exposure during pregnancy and the risk of major congenital malformations and adverse pregnancy outcomes: results from the Norwegian Mother and Child Cohort 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 exposure during pregnancy and the risk of major congenital malformations and adverse pregnancy outcomes: results from the Norwegian Mother and Child Cohort Study.
Author Nezvalová-Henriksen K., Spigset O., Nordeng H.
Country Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway.
Year 2010
Numbers Pubmed ID: 20132339

Secondary Publication Information
UI Title Author Country Year
Prenatal triptan exposure and neurodevelopmental outcomes in 5-year-old children: Follow-up from the Norwegian Mother and Child Cohort Study. Harris GE., Wood M., Ystrom E., Nordeng H. Pharmacoepidemiology & Drug Safety Research Group, School of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway. 2018
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Errata in "Triptan exposure during pregnancy and the risk of major congenital malformations and adverse pregnancy outcomes: results from the norwegian mother and child cohort study". Nezvalová-Henriksen K., Spigset O., Nordeng HM. -- Not Found -- 2012
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Longitudinal changes in neurodevelopmental outcomes between 18 and 36 months in children with prenatal triptan exposure: findings from the Norwegian Mother and Child Cohort Study. Wood ME., Frazier JA., Nordeng HM., Lapane KL. The University of Oslo School of Pharmacy, Oslo, Norway The University of Massachusetts Medical School, Worcester, Massachusetts, USA PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, University of Oslo, Oslo, Norway. 2016
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Prenatal Triptan Exposure and Internalising and Externalising Behaviour Problems in 3-Year-Old Children: Results from the Norwegian Mother and Child Cohort Study. Wood ME., Lapane K., Frazier JA., Ystrom E., Mick EO., Nordeng H. Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA. 2016
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Extraction Form: Extraction form for Direct Evidence (Primary Studies)
Arms
Number Title Description Comments
1 Triptans: Any
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2 Triptans: Any (before pregnancy only)
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3 Triptans: None (before or during pregnancy)
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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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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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Matching
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Multiple regression
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Matching
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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? ... Non-industry, specify name(s) of agency... ... Norwegian Ministry of Health, NIH, Norwegian Research Council
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Does the study have a NAME or ACRONYM? ... Yes, specify... ... Norwegian Mother and Child Cohort Study
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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? 1994
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2008
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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: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 1045 805 4050 5900
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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) <20 years <20 years <20 years
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0.8 0.3 1.1
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20-29 years 20-29 years 20-29 years
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40.8 44.5 44.1
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30-39 years 30-39 years 30-39 years
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56.8 54.2 52.9
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>=40 years >=40 years >=40 years
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1.7 1.1 1.9
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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
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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
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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 - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 1045 805 NR
Counts 75 22 NR
Percentage 7.2 2.7 NR
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 455 805 NR
Counts 69 22 NR
Percentage 15.2 2.7 NR
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 229 805 NR
Counts 49 22 NR
Percentage 21.4 2.7 NR
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 1045 805 NR
Counts 75 11 NR
Percentage 4.4 1.4 NR
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 455 805 NR
Counts 43 11 NR
Percentage 9.5 1.4 NR
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 229 805 NR
Counts 30 11 NR
Percentage 13.1 1.4 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 1045 805 NR
Counts 0 2 NR
Percentage 0.0 0.2 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 455 805 NR
Counts 0 2 NR
Percentage 0.0 0.2 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 229 805 NR
Counts 0 2 NR
Percentage 0.0 0.2 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 1045 805 NR
Counts 6 3 NR
Percentage 0.6 0.4 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 455 805 NR
Counts 6 3 NR
Percentage 1.3 0.4 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 229 805 NR
Counts 3 3 NR
Percentage 1.3 0.4 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


1 years

N Analyzed 1045 805 NR
Counts 5 0 NR
Percentage 0.5 0.0 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


1 years

N Analyzed 455 805 NR
Counts 5 0 NR
Percentage 1.1 0.0 NR
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


1 years

N Analyzed 229 805 NR
Counts 2 0 NR
Percentage 0.9 0.0 NR
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 1045 805 NR
Counts 65 19 NR
Percentage 6.2 2.3 NR
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 455 805 NR
Counts 63 19 NR
Percentage 13.9 2.4 NR
Outcome: Adverse events - Fetal/Infant - Low birth weight      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 229 805 NR
Counts 40 19 NR
Percentage 17.5 2.3 NR
Outcome: Adverse events - Fetal/Infant - Preterm birth      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 1045 805 NR
Counts 86 30 NR
Percentage 8.2 3.7 NR
Outcome: Adverse events - Fetal/Infant - Preterm birth      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 455 805 NR
Counts 82 30 NR
Percentage 18.0 3.7 NR
Outcome: Adverse events - Fetal/Infant - Preterm birth      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 229 805 NR
Counts 55 30 NR
Percentage 24.0 3.7 NR
Outcome: Adverse events - Fetal/Infant - Perinatal complications      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


1 minutes

N Analyzed 1045 805 NR
Counts 88 18 NR
Percentage 8.4 2.2 NR


5 minutes

N Analyzed 1045 805 NR
Counts 22 4 NR
Percentage 2.1 0.5 NR
Outcome: Adverse events - Fetal/Infant - Perinatal complications      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


1 minutes

N Analyzed 455 805 NR
Counts 81 18 NR
Percentage 2.2 NR


5 minutes

N Analyzed 455 805 NR
Counts 20 4 NR
Percentage 0.5 NR
Outcome: Adverse events - Fetal/Infant - Perinatal complications      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


1 minutes

N Analyzed 229 805 NR
Counts 55 18 NR
Percentage 24.0 2.2 NR


5 minutes

N Analyzed 229 805 NR
Counts 11 4 NR
Percentage 4.8 0.5 NR
Outcome: Adverse events - Maternal - Other      Population: All Participants
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 1045 805 NR
Counts 255 63 NR
Percentage 24.4 7.8 NR
Outcome: Adverse events - Maternal - Other      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 455 805 NR
Counts 228 63 NR
Percentage 50.1 7.8 NR
Outcome: Adverse events - Maternal - Other      Population: 2nd and/or 3rd trimester
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 229 805 NR
Counts 41 63 NR
Percentage 17.9 7.8 NR
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


3 years

N Analyzed 1085 NR 3354 0.77
Counts 101 NR 297 1.27
Percentage 9.3 NR 8.9 0.99


5 years

N Analyzed 340 NR 1457 0.44
Counts 25 NR 15 1.05
Percentage 7.4 NR 10.6 0.68
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: 1st trimester Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


3 years

N Analyzed 304 NR 4135 0.98
Counts 40 NR 358 3.14
Percentage 13.2 NR 8.7 1.75
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: 2nd and/or 3rd trimester Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


3 years

N Analyzed 137 NR 4302 0.23
Counts 11 NR 387 1.51
Percentage 8.0 NR 9.0 0.59
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


3 years

N Analyzed 396 NR 3354 0.80
Counts 27 NR 260 1.35
Percentage 6.8 NR 7.8 1.04


5 years

N Analyzed 343 NR 1482 0.68
Counts 42 NR 169 1.37
Percentage 12.2 NR 11.4 0.97
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: 1st trimester Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


3 years

N Analyzed 304 NR 4135 0.57
Counts 20 NR 326 2.82
Percentage 6.6 NR 7.9 1.27
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: 2nd and/or 3rd trimester Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


3 years

N Analyzed 137 NR 4302 0.16
Counts 7 NR 339 3.14
Percentage 5.1 NR 7.9 0.70
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 11.0 7.8 8.1


3 years

N Analyzed 495 1002 4050 0.70 0.70
Counts 1.75 1.43
Percentage 10.0 6.5 7.6 1.11 1.00
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 3.2 5.3 5.1


3 years

N Analyzed 495 1002 4050 1.03 1.27
Counts 4.53 4.90
Percentage 6.3 4.7 3.9 2.18 2.51
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 9.2 9.7 9.8


3 years

N Analyzed 495 1002 4050 1.02 1.04
Counts 2.80 2.36
Percentage 8.3 4.7 5.3 1.70 1.57
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 4.9 3.5 4.0


3 years

N Analyzed 495 1002 4050 0.52 0.81
Counts 1.63 2.08
Percentage 12.3 9.6 7.7 0.92 1.30
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 8.8 6.8 9.3


3 years

N Analyzed 495 1002 4050 0.44 0.70
Counts 1.38 1.82
Percentage 6.3 6.4 6.1 0.78 1.13
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 8.1 6.2 8.7


3 years

N Analyzed 495 1002 4050 0.41 0.66
Counts 1.14 1.57
Percentage 9.5 10.8 10.5 0.69 1.02
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Neurodevelopmental      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 1.6 3.3 2.3


3 years

N Analyzed 495 1002 4050 0.23 0.17
Counts 3.19 2.03
Percentage 1.2 3.0 3.0 0.86 0.58
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Neurodevelopmental      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 13.9 11.6 11.5


3 years

N Analyzed 495 1002 4050 0.52 0.56
Counts 1.37 1.29
Percentage 9.5 9.4 9.2 0.85 0.85
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months) Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR) (36 vs. 18 months)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: Any (before pregnancy only) Triptans: Any vs. Triptans: None (before or during pregnancy)


1.5 years

N Analyzed 495 1002 4050
Counts
Percentage 3.4 4.1 3.8


3 years

N Analyzed 495 1002 4050 0.56 0.48
Counts 2.68 1.95
Percentage 4.6 4.5 5.2 1.22 0.97




N Analyzed
Counts
Percentage
Adj. 95% CI low Adj. 95% CI high Adj. Risk Ratio (RR)
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


5 years

N Analyzed 347 NR 1479 0.50
Counts 27 NR 135 1.18
Percentage 7.8 NR 9.1 0.77
95% CI low 95% CI high Adjusted Mean Difference
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


5 years

N Analyzed 345 NR 1483 -2.3
Mean 49.7 NR 50.5 0.29
SD 9.9 NR 10.0 -1.02
95% CI low 95% CI high Adjusted Mean Difference
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


5 years

N Analyzed 351 NR 1493 -1.35
Mean 49.3 NR 50.1 1.23
SD 10.2 NR 10.2 -0.06
95% CI low 95% CI high Adjusted Mean Difference
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


5 years

N Analyzed 348 NR 1480 -2.08
Mean 50.1 NR 50.5 0.65
SD 10.0 NR 10.1 -0.71
95% CI low 95% CI high Adjusted Mean Difference
Outcome: Adverse events - Fetal/Infant - Behavioral/Social      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: Any (before pregnancy only) Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


5 years

N Analyzed 349 NR 1492 -0.30
Mean 51.0 NR 49.6 3.02
SD 10.4 NR 10.5 1.66


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 High High losses to follow up for various outcomes
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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 Doses were not well described
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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.