Advanced Search

Study Preview



Study Title and Description

Pregnancy outcome after anti-migraine triptan use: A prospective observational 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?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Pregnancy outcome after anti-migraine triptan use: A prospective observational cohort study.
Author Spielmann K., Kayser A., Beck E., Meister R., Schaefer C.
Country 1 Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Berlin, Germany.
Year 2018
Numbers Pubmed ID: 28758416

Secondary Publication Information
UI Title Author Country Year
https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00007660
  • Comments Comments (
    0
    ) |



Extraction Form: Extraction form for Direct Evidence (Primary Studies)
Arms
Number Title Description Comments
1 Triptans: Any
  • Comments Comments (
    0
    ) |
2 Triptans: None (before or during pregnancy)
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Which KEY QUESTION (KQ) does this study address? KQ2: Treatment of primary headache
  • Comments Comments (
    0
    ) |
What is the STUDY DESIGN? Nonrandomized comparative study (NRCS)
  • Comments Comments (
    0
    ) |
What was the ANALYTIC METHOD used to control for differences between study groups? Multiple regression
  • Comments Comments (
    0
    ) |
What was the DIRECTIONALITY of the study? Retrospective
  • Comments Comments (
    0
    ) |
In what COUNTRY was the study done? ... Other, specify ... Germany
  • Comments Comments (
    0
    ) |
What was the FUNDING SOURCE of the study? Explicitly reported that the study was not funded.
  • Comments Comments (
    0
    ) |
Does the study have a NAME or ACRONYM? No/not reported
  • Comments Comments (
    0
    ) |
Does the study have a CLINICALTRIALS.GOV IDENTIFICATION NUMBER? No/not reported
  • Comments Comments (
    0
    ) |
What were the START and END YEARS of the study? 1999
  • Comments Comments (
    0
    ) |
2014
  • Comments Comments (
    0
    ) |
What were the study INCLUSION criteria? Migraine
  • Comments Comments (
    0
    ) |
What were the study EXCLUSION criteria? NR
  • Comments Comments (
    0
    ) |
Do you have any NOTES regarding the design or any overall aspects of this study?
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Triptans: Any Triptans: None (before or during pregnancy) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 432 475 907
  • Comments Comments (
    0
    ) |
What were the RACE/ETHNICITY of the women in the study? Not reported Not reported Not reported
  • Comments Comments (
    0
    ) |
What was the AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Median 33 Median 32 Not reported
  • Comments Comments (
    0
    ) |
IQR 30, 37 IQR 29, 36
  • Comments Comments (
    0
    ) |
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? 1st trimester...% NR 1st trimester...% NR Not reported...%
  • Comments Comments (
    0
    ) |
2nd trimester...% NR 2nd trimester...% NR
  • Comments Comments (
    0
    ) |
3rd trimester...% NR 3rd trimester...% NR
  • Comments Comments (
    0
    ) |
What was the GESTATIONAL AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Median 8 Median 9 Not reported
  • Comments Comments (
    0
    ) |
IQR 6.3, 12 IQR 6.3, 13
  • Comments Comments (
    0
    ) |
What was the UNIT for the gestational age you answered in the previous question? Weeks Weeks
  • Comments Comments (
    0
    ) |
What was the GRAVIDITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported Not reported
  • Comments Comments (
    0
    ) |
What was the PARITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported Not reported
  • Comments Comments (
    0
    ) |
What were the TYPES of PRIMARY HEADACHE in the women in the study? Migraine...% 100 Migraine...% 100 Migraine...% 100
  • Comments Comments (
    0
    ) |
What percentage of the women in the study had a HISTORY OF PRIMARY HEADACHE? Not reported Not reported Not reported
  • Comments Comments (
    0
    ) |
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 - Congenital anomalies or other newborn abnormalities      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 372 431 1.00
Counts 25 28 0.51
Percentage 6.7 6.5 2.1
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 438
Counts 24
Percentage 7.3
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429 1.01
Counts 9 12 0.3
Percentage 2.5 2.8 3.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 323
Counts 8
Percentage 2.5
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy) Comparison Measure Triptans: None (before or during pregnancy) vs. Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 364 427 1.48
Counts 11 12 0.5
Percentage 3.0 2.8 4.4
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 320
Counts 11
Percentage 3.4
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 369 429 1.10
Counts 5 4 0.2
Percentage 1.4 0.9 6.6
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 325
Counts 5
Percentage 1.5
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


Not reported N/A

N Analyzed 432 475 1.41
Counts 50 37 0.9
Percentage 11.6 7.8 2.2
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Not reported N/A

N Analyzed 387
Counts 49
Percentage 12.7
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 432 475
Counts 1 1
Percentage 0.2 0.2
Outcome: Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death      Population: 1st trimester
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 387
Counts 1
Percentage 0.3
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Adverse events - Maternal - Elective or induced abortion      Population: All Participants Between-Arm Comparisons
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy) Comparison Measure Triptans: Any vs. Triptans: None (before or during pregnancy)


Not reported N/A

N Analyzed 432 387 1.58
Counts 23 23 0.8
Percentage 5.3 5.9 3.0
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3
Outcome: Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities      Population: All Participants
Time Point Measure Triptans: Any Triptans: None (before or during pregnancy)


Delivery N/A

N Analyzed 367 429
Counts 1
Percentage 0.3


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
  • Comments Comments (
    0
    ) |
Q2: Did the study divide the follow up time of each individual participant into the different interventions? No
  • Comments Comments (
    0
    ) |
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? Yes
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? No
  • Comments Comments (
    0
    ) |
Q6: Risk of bias judgement for BIAS DUE TO CONFOUNDING Low
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
  • Comments Comments (
    0
    ) |
Q11: Did the start and follow up calendar years coincide for most participants in the study?
  • Comments Comments (
    0
    ) |
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?
  • Comments Comments (
    0
    ) |
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
  • Comments Comments (
    0
    ) |
Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence
  • Comments Comments (
    0
    ) |
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
  • Comments Comments (
    0
    ) |
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study
  • Comments Comments (
    0
    ) |
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.
  • Comments Comments (
    0
    ) |
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.
  • Comments Comments (
    0
    ) |
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.
  • Comments Comments (
    0
    ) |
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
  • Comments Comments (
    0
    ) |
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data High Large loss to followup - 162/594 women.
  • Comments Comments (
    0
    ) |
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Low
  • Comments Comments (
    0
    ) |
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
  • Comments Comments (
    0
    ) |
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? No A variety of doses across the study participants
  • Comments Comments (
    0
    ) |
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
  • Comments Comments (
    0
    ) |

Quality Rating
Guideline Used Overall Rating