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The 4-vessel Sampling Approach to Integrative Studies of Human Placental Physiology In Vivo
Published on: August 2, 2017
Systematic review with meta-analysis: the risks of proton pump inhibitors during pregnancy
Cheng Mei Li1,2,3, Alexandra Zhernakova4, Lars Engstrand1,2
1Centre for Translational Microbiome Research, Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
Insights
Maternal use of proton pump inhibitors (PPIs) during pregnancy is linked to a higher risk of congenital malformations in newborns. Further research is needed to confirm these findings and explore specific drug effects.
Area of Science:
- Obstetrics and Gynecology
- Neonatal Health
- Pharmacovigilance
Background:
- Safety concerns exist regarding long-term proton pump inhibitor (PPI) use, including during pregnancy.
- Assessing the potential risks of PPIs on neonatal outcomes is crucial for maternal and child health.
Purpose of the Study:
- To systematically review and meta-analyze the risk of adverse neonatal outcomes associated with maternal intake of PPIs.
- To compare risks between PPI users, Histamine-2 receptor antagonist (H2RA) users, and non-users.
Main Methods:
- A systematic search of PubMed, Web of Science, Cochrane Database, and Embase was conducted.
- Included studies compared pregnant individuals using PPIs or H2RAs with non-users, examining outcomes like congenital malformations, preterm birth, and low birth weight.
- Random-effects modeling was used to pool odds ratios (OR) and 95% confidence intervals (CI).
Main Results:
- Maternal PPI use was associated with an increased risk of congenital malformations (OR 1.28).
- This association was particularly notable in case-control studies (OR 2.04).
- No significant associations were found between PPIs and other adverse outcomes, while H2RA use showed a potential link to increased preterm birth risk.
Conclusions:
- Maternal PPI use during pregnancy is suggested to be associated with congenital malformations.
- The current meta-analysis lacked sufficient power to evaluate specific malformations or individual PPI drugs.
- Further investigation is warranted to clarify the risks associated with PPI use in pregnancy.
Background:
There have been safety concerns considering long-term proton pump inhibitor (PPI) use, also during pregnancy.
Aims:
To assess the risk of adverse neonatal outcomes associated with maternal intake of PPIs by means of systematic review and meta-analysis.
Methods:
The systematic search included PubMed, Web of Science, Cochrane Database and Embase (inception until June 2019). All studies reporting ≥1 adverse pregnancy outcome comparing PPI users to non-users. Histamine-2 receptor antagonists (H2RA) were also compared to both non-users and PPI users. Outcomes included congenital malformations, abortion, stillbirth, neonatal death, preterm birth, small for gestational age and low birth weight. Pooled odds ratios (OR) and 95% confidence intervals (CI) were obtained by random-effects modelling. PROSPERO study-protocol: CRD42018103320.
Results:
In total, 26 observational studies (20 cohort, 6 case-control studies) were identified, of which 19 assessed PPIs and 12 H2RA. PPI use was associated with an increased risk of congenital malformations (OR 1.28, 95% CI 1.09-1.52), especially in case-control studies (OR 2.04, 1.46-2.86). No associations were found between H2RA and congenital malformations. No significant associations were found between PPI use and abortions, stillbirth, neonatal death, preterm birth and low-birth weight, although H2RA use may be associated with an increased risk of preterm birth (OR 1.25, 95% CI 1.02-1.56). Although statistical heterogeneity and the risk of bias were overall low, clinical heterogeneity, information and selection bias may be present in the individual studies.
Conclusions:
This meta-analysis suggests an association between maternal PPI use and congenital malformations in humans, yet power was insufficient to assess specific malformations and drugs.
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