Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: A systematic review and meta-analysis. 2022

Laura J O'Byrne, and Safi G Alqatari, and Gillian M Maher, and Aoife M O'Sullivan, and Ali S Khashan, and Grainne P Murphy, and Fergus P McCarthy
INFANT Research Centre, University College Cork, Cork, Ireland.

Biologic medications, specifically tumour necrosis factor-α (TNF-α) inhibitors, have become increasingly prevalent in the treatment of chronic inflammatory disease (CID) in pregnancy. To determine pregnancy outcomes in women with CID exposed to biologics during pregnancy. PubMed and EMBASE databases were searched through January 1998-July 2021. Peer-reviewed, English-language cohort, case-control, cross-sectional studies, and case series that contained original data. Two authors independently conducted data extraction. A meta-analysis of proportions using a random-effects model was used to pool outcomes. Linear regression analysis was used to compare the mean of proportions of outcomes across exposure groups using the 'treated' group as the reference category. All studies were evaluated using an appropriate quality assessment tool. The GRADE approach was used to assess the overall certainty of evidence. Thirty-five studies, describing 11 172 pregnancies, were eligible for inclusion. Analysis showed pooled proportions for congenital malformations as follows: treated 0.04 (95% CI 0.03-0.04; I2  = 77) versus disease-matched 0.04 (95% CI 0.03-0.05. I2  = 86; p = 0.238); preterm delivery treated 0.04 (95% CI 0.10-0.14; I2  = 88) versus disease-matched 0.10 (95% CI 0.09-0.12; I2  = 87; p = 0.250); severe neonatal infection: treated 0.05 (95% CI 0.03-0.07; I2  = 88) versus disease-matched 0.05 (95% CI 0.02-0.07; I2  = 94; p = 0.970); low birthweight: treated 0.10 (95% CI 0.07-0.12; I2  = 93) versus disease-matched 0.08 (95% CI 0.07-0.09; I2  = 0; p = 0.241); pooled miscarriage: treated 0.13 (95% CI 0.10-0.15; I2  = 77) versus disease-matched 0.08 (95% CI 0.04-0.11; I2  = 5; p = 0.078); pre-eclampsia; treated 0.01 (95% CI 0.01-0.02; I2  = 0) versus disease-matched 0.01 (95% CI 0.00-0.01; I2  = 0; p = 0.193). No statistical differences in proportions were observed. GRADE certainty of findings was low to very low. We demonstrated comparable pregnancy outcomes in pregnancies exposed to biologics, disease-matched controls and CID-free pregnancies using the GRADE approach.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D011256 Pregnancy Outcome Results of conception and ensuing pregnancy, including LIVE BIRTH; STILLBIRTH; or SPONTANEOUS ABORTION. The outcome may follow natural or artificial insemination or any of the various ASSISTED REPRODUCTIVE TECHNIQUES, such as EMBRYO TRANSFER or FERTILIZATION IN VITRO. Outcome, Pregnancy,Outcomes, Pregnancy,Pregnancy Outcomes
D011295 Prenatal Care Care provided the pregnant woman in order to prevent complications, and decrease the incidence of maternal and prenatal mortality. Antenatal Care,Care, Antenatal,Care, Prenatal
D003430 Cross-Sectional Studies Studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time. This contrasts with LONGITUDINAL STUDIES which are followed over a period of time. Disease Frequency Surveys,Prevalence Studies,Analysis, Cross-Sectional,Cross Sectional Analysis,Cross-Sectional Survey,Surveys, Disease Frequency,Analyses, Cross Sectional,Analyses, Cross-Sectional,Analysis, Cross Sectional,Cross Sectional Analyses,Cross Sectional Studies,Cross Sectional Survey,Cross-Sectional Analyses,Cross-Sectional Analysis,Cross-Sectional Study,Cross-Sectional Surveys,Disease Frequency Survey,Prevalence Study,Studies, Cross-Sectional,Studies, Prevalence,Study, Cross-Sectional,Study, Prevalence,Survey, Cross-Sectional,Survey, Disease Frequency,Surveys, Cross-Sectional
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001688 Biological Products Complex pharmaceutical substances, preparations, or matter derived from organisms usually obtained by biological methods or assay. Biologic,Biologic Drug,Biologic Product,Biological,Biological Drug,Biological Medicine,Biological Product,Biologics,Biopharmaceutical,Natural Product,Natural Products,Biologic Drugs,Biologic Medicines,Biologic Pharmaceuticals,Biologic Products,Biological Drugs,Biological Medicines,Biologicals,Biopharmaceuticals,Products, Biological,Drug, Biologic,Drug, Biological,Drugs, Biologic,Drugs, Biological,Medicine, Biological,Medicines, Biologic,Medicines, Biological,Pharmaceuticals, Biologic,Product, Biologic,Product, Biological,Product, Natural
D047928 Premature Birth CHILDBIRTH before 37 weeks of PREGNANCY (259 days from the first day of the mother's last menstrual period, or 245 days after FERTILIZATION). Preterm Birth,Birth, Premature,Birth, Preterm,Births, Premature,Births, Preterm,Premature Births,Preterm Births

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