Lupus & antiphospholipid syndrome
First trimester exposure to hydroxychloroquine during pregnancy and major congenital malformations: a systematic review and meta-analysis
Pooled result · Any MCMResult — go to the resultOdds ratio 1.27 95% CI 1.11–1.45Authors' conclusion
A slight association between HCQ exposure and MCM was observed, with low certainty of evidence. Given the well-established maternal/fetal benefits of HCQ in systemic lupus erythematosus, these results do not support changes in current clinical practice regarding its use during pregnancy. For other indications where alternatives exist, its use during pregnancy should be considered on a case-by-case basis.
Study context
- Population
- Pregnancies with or without hydroxychloroquine exposure during the first trimester18 cohorts, 1 case-control and 1 RCT, 4260 hydroxychloroquine (HCQ)-exposed and 361,802 unexposed-pregnancies, from 4311 records · cohorts 18 · case-control 1 · RCT 1
- Participants
- 20 studies participants
- Comparison
- HCQ use during the first trimester of pregnancy vs no exposure
- HCQ-EXPOSEDn = 4,260
- UNEXPOSEDn = 361,802reference
- Outcome
- Any MCM
Methodological detailsrandomised controlled trials (RCTs) and comparative observational studies included, fixed-effects and random-effects models (REM) based on adjusted or crude ORs
- Randomised controlled trials (RCTs) and comparative observational studies included
- Fixed-effects and random-effects models (REM) based on adjusted or crude ORs
Pooled result
As reported in the abstract
Odds ratio
1.27
95% CI 1.11–1.45
HCQ-EXPOSEDvs UNEXPOSED
OR 1.27 (95% CI 1.11–1.45)
Further pooled results
| Outcome | aOR (95% CI) | |
|---|---|---|
| Any MCM, pooled adjusted ORREM, I²=0.0%, Tau2=0, n=8 | 1.29 (1.09–1.53) | |
| 0.512Adjusted odds ratio (log scale) |
Risk of bias
- Serious
- n=4
- Critical
- n=15
- 'some concern' (RCT)
- n=1
Original publication
First trimester exposure to hydroxychloroquine during pregnancy and major congenital malformations: a systematic review and meta-analysis. RMD Open. Published 26 October 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →