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Randomized Controlled Trial
. 2025 Aug 8;25(1):830.
doi: 10.1186/s12884-025-07980-8.

Maternal phthalate exposure, gestational length, and preterm birth risk: a prospective cohort study nested within a randomised trial

Karen P Best  1   2 , Lisa N Yelland  3   4 , Liu Ge  3 , Zumin Shi  5 , Shalem Leemaqz  3 , Robert Gibson  3   6 , Maria Makrides  3   7 , Philippa Middleton  3   4
Affiliations
Randomized Controlled Trial

Maternal phthalate exposure, gestational length, and preterm birth risk: a prospective cohort study nested within a randomised trial

Karen P Best et al. BMC Pregnancy Childbirth. .

Abstract

Background: Preterm birth (< 37 weeks gestation) is a leading cause of infant morbidity and mortality, yet the underlying causes remain unknown in many cases. Environmental exposures, including endocrine-disrupting chemicals such as phthalates, have been implicated in preterm birth risk. Phthalates are commonly used as plasticisers in consumer products, resulting in widespread human exposure. While some studies suggest an association between maternal phthalate exposure and reduced gestational length, findings remain inconsistent. This study aimed to investigate the relationship between urinary phthalate metabolite concentrations and gestational length in an Australian pregnancy cohort.

Methods: This prospective cohort study was nested within the Omega-3 to Reduce the Incidence of Prematurity (ORIP) trial. A total of 605 women with singleton pregnancies from South Australia provided urine samples between 22- and 26-weeks' gestation for phthalate metabolite analysis. Thirteen phthalate metabolites were quantified using liquid chromatography-tandem mass spectrometry. Gestational age at birth was determined from medical records. Linear regression models assessed associations between phthalate concentrations and gestational length, adjusting for maternal characteristics including age, BMI, socioeconomic status, education, smoking, and alcohol consumption.

Results: Phthalate metabolites were detected in > 99% of urine samples, with the highest concentrations observed for mono-ethyl phthalate (MEP), mono-isobutyl phthalate (MiBP), and mono-butyl phthalate (MBP). There was no evidence of an association between phthalate exposure and gestational length in either unadjusted or adjusted analyses. No significant association was found between phthalate exposure and preterm birth risk.

Conclusions: Despite widespread phthalate exposure, no clear link was identified between maternal phthalate levels and shortened gestation in this Australian cohort. However, continued surveillance is needed to monitor emerging plasticiser exposures and inform public health policies on maternal and infant health.

Trial registration number: Australian New Zealand Clinical Trials Registry number, ACTRN12613001142729. Date of registration: 27/09/2013.

Keywords: Endocrine disrupting chemicals; Environment; Exposure; Phthalates; Pregnancy; Prematurity; Prenatal.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Ethics approval for this study was granted by the Women’s and Children’s Health Network Human Research Ethics Committee (HREC/16/WCHN/80). All participating women provided informed consent prior to inclusion in the study. The study adhered to the principles of the Declaration of Helsinki and complied with all applicable national guidelines and regulations. Consent for publication: Not applicable. This manuscript does not contain any individual person’s data in any form (including individual details, images, or videos). Competing interests: MM was President of the International Society for the Study of Fatty Acids and Lipids (ISSFAL), 2021–2024. No payments have been received in relation to this role. All other authors report no competing interests.

Figures

Fig. 1
Fig. 1
Participant flow for phthalate analysis nested within the ORIP Trial. ORIP, Omega-3 to reduce the incidence of preterm birth
See this image and copyright information in PMC

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