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Study Title and Description

Use of ondansetron during pregnancy and the risk of major congenital malformations: A systematic review and meta-analysis.



Key Questions Addressed
4 Indirect Evidence (Systematic Reviews): 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 Use of ondansetron during pregnancy and the risk of major congenital malformations: A systematic review and meta-analysis.
Author Kaplan YC., Richardson JL., Keskin-Arslan E., Erol-Coskun H., Kennedy D.
Country Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Center, Izmir, Turkey; Izmir Katip Celebi University School of Medicine, Department of Pharmacology Izmir, Turkey.
Year 2019
Numbers Pubmed ID: 30849498

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction Form for Indirect Evidence (Systematic Reviews)
Arms
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
How many DATABASES did the authors search? 3
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What was the YEAR of the last search? 2016
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How many STUDIES were included in the review? 8
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What INTERVENTIONS were addressed? Antiemetics: 5HT3 Antagonists
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Ondansetron
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Were MATERNAL adverse events reported? No
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Were FETAL/CHILD adverse events reported? Yes
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AMSTAR Item 1 - Did the authors specify the research questions and inclusion criteria for the SR? Yes
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AMSTAR Item 4 - Did the SR authors use a comprehensive literature search strategy? Yes
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AMSTAR Item 5 - Did the SR authors perform study selection in duplicate? Yes
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AMSTAR Item 6 - Did the SR authors perform data extraction in duplicate, either independently or through verification? Yes
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AMSTAR Item 8 - Did the SR authors describe the included studies in adequate detail? Yes
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AMSTAR Item 9 - Did the SR authors use a satisfactory technique for assessing the risk of bias in individual studies that were included in the SR? Yes
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AMSTAR Item 12 - Did the SR authors assess the potential impact of risk of bias in individual studies on the summary results, interpretation, discussion? No
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AMSTAR Item 11 - If meta-analysis (MA) was performed did the SR authors use appropriate methods for statistical combination of results? Yes
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AMSTAR Item 14 - Did the SR authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the SR? Yes
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AMSTAR Item 16 - Did the SR authors report the lack of significant potential of conflict of interest (COI) regarding conducting the SR? Yes
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What was the OVERALL QUALITY OF THE SYSTEMATIC REVIEW High
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MATERNAL Adverse Events - ANTEPARTUM
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MATERNAL Adverse Events - POSTPARTUM
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MATERNAL Adverse Events - DELIVERY
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MATERNAL Adverse Events - TIMING NOT REPORTED
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FETAL/CHILD Adverse Events - IN UTERO
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FETAL/CHILD Adverse Events - PERINATAL
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FETAL/CHILD Adverse Events - NEONATAL
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2
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OR
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1.66
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0.30
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9.09
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NS
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4
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OR
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1.55
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0.89
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2.69
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NS
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4
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OR
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1.61
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0.69
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3.75
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NS
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2
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OR
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1.21
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0.56
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2.58
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NS
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3
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OR
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0.89
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0.32
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2.50
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NS
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FETAL/CHILD Adverse Events - CHILD
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Baseline Characteristics
No baseline characteristics have been defined for this extraction form.



Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments

Quality Dimensions
No quality dimensions were specified.

Quality Rating
No quality rating data was found.