maternal treatment with opioid analgesics first jouurnal reading fda edit tayang
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Maternal treatment withopioid analgesics
and risk for birth defects
Presenter :dr Fista Divi AmesiaModerator :dr H. Hatta Ansyori SpOG (K)
1st Journal Reading
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Introduction
Treatment withopioid
Major birthdefects affectabout 3% of the4 million US live
births each yearand are aleading cause ofinfant mortality
1 % in US birth
Treatment withopioid
Often used insevere pain
SometimesCombined with
NSAID Some in low
doses used ascoughsuppresant
Treatment withopioid
In first trimesterthe effect todevelopmentfetus during
pregnancy arenot fullyunderstood
Mostly relatedwith CHD
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MATERIALS AND METHODS
Data from the National BirthDefects Prevention Study(NBDPS)
for infants born Oct 1, 1997,through Dec 31, 2005.
Study LocationArkansas, California,Georgia, Iowa, Massachusetts, NewJersey, New York, North Carolina,
Texas, and Utah
The study was approved by institutionalreview boards of the Centers forDisease Control and Prevention.
The subjects birth defect withunknowns etiologies ; birth defect withknown etiologies is excluded from this
study, mothers with preexistingdiabetes and opioid exposure in the
form of illicit drugs are excluded
an ongoing population-based case-control study.
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Results
Result
Therapeutic opioid use was reported by 2.6% of 17,449 casemothers and 2.0% of 6701 control mothers.
result
Treatment was statistically significantly associated withconoventricular septal defects (OR, 2.7; 95% CI, 1.1 6.3),atrioventricular septal defects (OR, 2.0; 95% CI, 1.23.6),hypoplastic left heart syndrome (OR, 2.4; 95% CI, 1.44.1),spina bifida (OR, 2.0; 95% CI, 1.33.2), or gastroschisis (OR,
1.8; 95% CI, 1.12.9) in infants.
result
associations between maternal therapeutic use of opioidmedications in early pregnancy and several types of CHD
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Associations between maternal opioid
analgesic treatment and specific major
birth defectsBirth defect Total no No. exposed aOR (95% CI)
Hypothesis-testing analysis
Controls 6701 134 Referent
Anencephaly/craniorachischis 340 9 1.7 (0.843.4)
Spina bifida 718 26 2.0(1.33.2)
Any of included heart defects 7724 211 1.4 (1.11.7)
Laterality defects with CHD 198 4 1.2 (0.423.2
Atrioventricular septal defect 175 9 2.4 (1.24.8)
Anomalous pulmonary venous
return
206 4 0.71 (0.222.3)
Sin le ventricle/com lex 201 4 1.1 0.423.2
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Associations between maternal opioid
analgesic treatment and specific major
birth defects
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Conclusion
Maternal opioid analgesictreatment early in pregnancy wasassociated with certain types ofbirth defects in infants, includingsome types of CHD,which are
important contributors to infantmorbidity and mortality.
Identification of a biologicallyplausible mechanism supports
this finding, although betterpathogenetic understanding isneeded to explain why opioid
analgesic treatment isassociated with some defects but
not others.
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Was a defined, representative sample of
patients assembled at a common (usuallyearly) point in the course of their disease?
Yes, they all used
opioid treatmentduring earlypregnancy
Was the follow-up of these patientssufficientlylong and complete?
Yes, all patientsfollow up from thesame time
Was outcome criteria assessed by blind ? Yes
If there was found subgroup with differentprognosis, Was there adjustment forimportant prognostic factors?
No, all result thesame
CRITICAL APPRAISAL PROGNOSTIC
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Was this result of this study important? Yes, especially formaternal treatment withopiod to prevent birthdefect in the future
How likely are the outcomes over time? Yes
How accurate prognostic prediction? 95% CI
Were the study patients similar to yourpatient?
Yes , many patient in ourcountry used the same
medications
Will the evidence make a clinicallyimportant impact on your conclusions
about what to offer or tell your patient?
Yes
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