NCT07855237

Brief Summary

Cadmium is a toxic heavy metal naturally present in the environment, whose human exposure has increased over recent decades due to diffuse anthropogenic contamination, particularly related to industrial activities and the use of mineral phosphate fertilizers in agriculture. Cadmium is characterized by its bioaccumulative properties and well-established toxicity, including renal and bone damage and carcinogenic effects. In pregnant women, several animal and human cohort studies have shown that cadmium can cross the placental barrier and accumulate in placental tissue. Placental cadmium exposure has been associated with impaired placental function and adverse perinatal outcomes, including fetal growth restriction and increased neonatal morbidity. In the general population without occupational exposure, diet represents the main source of cadmium exposure, apart from tobacco smoking. Fetal growth, commonly assessed through birth weight adjusted for gestational age, is a major determinant of neonatal and long-term health outcomes. This monocentric prospective pilot study aims to assess fetal exposure to cadmium during pregnancy using placental cadmium concentration as a biomarker. Placental samples will be collected at delivery from women giving birth at Amiens University Hospital, and cadmium levels will be measured using inductively coupled plasma mass spectrometry. The association between placental cadmium concentration and fetal growth will be explored. Fetal growth will be evaluated using birth weight adjusted for gestational age, expressed as a standardized z-score. Maternal urinary and blood cadmium concentrations will also be measured to characterize maternal exposure and explore correlations between biological matrices. Placental efficiency, defined as the fetal-to-placental weight ratio, will be assessed as an indicator of placental function. The results of this pilot study will provide preliminary data to inform future larger-scale epidemiological and mechanistic studies on prenatal cadmium exposure and pregnancy outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Sep 2026Dec 2026

Study Start

First participant enrolled

September 21, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

biomonitoringenvironmental exposurebirth weightfetal growthPlacentaCadmium

Outcome Measures

Primary Outcomes (1)

  • association between placental cadmium levels and fetal growth

    investigate the association between placental cadmium levels and fetal growth.

    at 2 months

Secondary Outcomes (4)

  • Association between maternal urinary cadmium concentration and fetal growth

    at 2 months

  • Association between maternal blood cadmium concentration and fetal growth

    at 2 months

  • Association between placental cadmium concentration and placental efficiency

    at 2 months

  • Association between maternal dietary patterns and estimated dietary cadmium intake and cadmium concentrations measured in placental tissue

    at 2 months

Interventions

maternal blood samples are collected at admission for delivery as part of standard obstetric care.

Placental tissue samples are collected at delivery,

maternal urine samples are obtained during routine prenatal visits,

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgestational mother
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women delivering at term or preterm who are patients at Amiens University Hospital,

You may qualify if:

  • Pregnant women aged 18 years or older
  • Singleton pregnancy
  • Planned delivery at the maternity unit of Amiens University Hospital (CHU Amiens)
  • Ability to receive study information and provide informed non-opposition/consent according to French regulations for non-interventional research

You may not qualify if:

  • Women under legal protection measures, including guardianship, curatorship, or judicial safeguard
  • Inability to understand the study objectives or the constraints of the protocol (language barrier, cognitive impairment, or other reasons)
  • Lack of affiliation to a social security system, as required by French regulations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start

September 21, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations