Maternal Treatment With Opioid Analgesics First Jouurnal Reading FDA EDIT Tayang

8/3/2019 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


Often used insevere pain

SometimesCombined with

NSAID Some in low

doses used ascoughsuppresant


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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Documents

Maternal Treatment With Opioid Analgesics First Jouurnal Reading FDA EDIT Tayang