News | Women's Health | August 20, 2019

Some Pregnant Women Are Exposed to Gadolinium in Early Pregnancy

New study suggests ways to enhance pregnancy screening measures to limit fetal exposure to controversial contrast agent

Some Pregnant Women Are Exposed to Gadolinium in Early Pregnancy

August 20, 2019 — A small but concerning number of women are exposed to a commonly used magnetic resonance imaging (MRI) contrast agent early in their pregnancy, likely before many of them are aware that they are pregnant, according to a study published in the journal Radiology.1 The results support adherence to effective pregnancy screening measures to help reduce inadvertent exposures to these contrast agents during early pregnancy.

Gadolinium-based contrast agents (GBCAs) are used in as many as 45 percent of MRI exams in the United States to improve the visualization of organs and tissue. Recent evidence shows that trace levels of gadolinium may be retained in the body after the MRI, although the implications of this are not yet understood.

Gadolinium can cross the placenta and enter the fetal circulation. The safety of GBCAs in pregnant women has not been established, and their use during pregnancy is not recommended unless essential to the health of the woman or fetus. Available data from cohort studies and case reports have revealed inconsistent findings regarding the association between gadolinium and adverse fetal outcomes.

To obtain a more precise idea of the prevalence of GBCA exposure among pregnant women, study lead author Steven Bird, Pharm.D., Ph.D., of the U.S. Food and Drug Administration’s (FDA) Division of Epidemiology, and colleagues analyzed data on U.S. pregnancies resulting in live births between 2006 and 2017. The data was collected from 16 partners of the FDA’s Sentinel System, a program that allows for active surveillance of healthcare data from multiple sources to monitor the safety of regulated medical products.

The data revealed exposures to GBCAs in 5,457 of 4,692,744 live births, a number corresponding to one in 860 pregnancies. Most of the exposures came from contrast MRI examinations of the head, although the number of pelvic and abdominal MRIs were also noteworthy. Almost three-quarters of exposures occurred during the first trimester. The results strongly suggested that inadvertent exposure to GBCAs may occur before pregnancy is recognized.

“Unintended fetal exposures to gadolinium can occur during early pregnancy among women who are not yet aware they are pregnant. Increased attention to existing pregnancy screening measures may help reduce inadvertent exposures to gadolinium contrast,” Bird said.

The FDA has advised all MRI centers to provide a medication guide to outpatients during their first gadolinium contrast administration, stating that pregnant women and young children may be at increased risk from gadolinium staying in the body.

The researchers suggested several ways radiology imaging centers might avoid inadvertent administration of GBCAs to pregnant women. Among the tools are: 

  • A safety screening form asking about the potential for pregnancy; 
  • Direct questioning of women by radiologic technologists regarding pregnancy; 
  • Prominently displayed signs asking women to notify radiology staff if they may be pregnant; and 
  • Pregnancy testing when appropriate.

The FDA is continuing to monitor reports of adverse events associated with gadolinium exposure in utero. While this study was not designed to assess health outcomes of this early exposure for women and/or infants, the FDA is collaborating on and funding a study to evaluate potential risk for stillbirth and other neonatal adverse effects following in utero exposure to gadolinium in a large group of pregnant Medicaid beneficiaries.

For more information: www.pubs.rsna.org/journal/radiology

 

Reference 

1. Bird S.T., Gelperin K., Sahin L., et al. First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies. Radiology, published online Aug. 20, 2019. https://doi.org/10.1148/radiol.2019190563

Related Content

Chief among the myriad practical updates to minimize risks for patients and imaging personnel alike is a tiered approach for delaying both outpatient and inpatient cross-sectional interventional procedures

For procedural delays that will not adversely affect patient outcome, Fananapazir and colleagues proposed the following tiered approach for both outpatient and inpatient scenarios: urgent procedures, procedures that should be performed within 2 weeks, procedures that should be performed within 2 months, and procedures that can safely be delayed 2 or 6 months. Courtesy of American Journal of Roentgenology (AJR)

News | Coronavirus (COVID-19) | June 05, 2020
June 5, 2020 — An...
Early diagnosis of cancer is one of the highest-priority problem for the healthcare system, because it is critical for overall treatment success and saving patients' lives. Diffusion-weighted magnetic resonance imaging (DWI) may be used to detect a malignancy in various tissues and organs. It has the advantage of providing insight into the diffusion of water molecules in body tissues without exposing patients to radiation.

DWI of the phantom with polyvinylpyrrolidone (PVP) solutions (b value 500 s/mm2). Image courtesy of Kristina Sergunova et al.

News | Magnetic Resonance Imaging (MRI) | June 02, 2020
June 2, 2020 — Early diagnosis of cancer is one of the highest-priority problem for the healthcare system, because it
Developed by medical AI company Lunit, Software detects breast cancer with 97% accuracy; Study in Lancet Digital Health shows that Lunit INSIGHT MMG-aided radiologists showed an increase in sensitivity

Lunit INSIGHT MMG

News | Artificial Intelligence | June 02, 2020
June 2, 2020 — Lunit announced that its artificia...
The FDA has approved Lilly’s TAUVID (flortaucipir F 18 injection), a radioactive diagnostic agent, for PET imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease

Getty Images

News | Contrast Media | June 01, 2020
June 1, 2020 — TAUVID, a radioactive diagnostic agent, has been approved by the FDA for...
AIR Recon DL delivers shorter scans and better image quality (Photo: Business Wire)

AIR Recon DL delivers shorter scans and better image quality (Photo: Business Wire).

News | Artificial Intelligence | May 29, 2020
May 29, 2020 — GE Healthcare announced U.S.
Largest case series (n=30) to date yields high frequency (77%) of negative chest CT findings among pediatric patients (10 months-18 years) with COVID-19, while also suggesting common findings in subset of children with positive CT findings

A and B, Unenhanced chest CT scans show minimal GGOs (right lower and left upper lobes) (arrows) and no consolidation. Only two lobes were affected, and CT findings were assigned CT severity score of 2. Image courtesy of American Journal of Roentgenology (AJR)

News | Coronavirus (COVID-19) | May 29, 2020
May 29, 2020 — An investigation published open-access in the ...
AI has the potential to help radiologists improve the efficiency and effectiveness of breast cancer imaging

Getty Images

Feature | Breast Imaging | May 28, 2020 | By January Lopez, M.D.
Headlines around the world the past several months declared that...
United Imaging's uMR OMEGA is designed to provide greater access to magnetic resonance imaging (MRI) with the world’s first ultra-wide 75-cm bore 3T MRI.
News | Magnetic Resonance Imaging (MRI) | May 27, 2020
May 27, 2020 — United Imaging's...
There were several new developments in digital radiography (DR) technology at the 2019 Radiological Society of North America (RSNA) annual meeting. These trends included integration of artificial intelligence (AI) auto detection technologies, more durable glassless detector plates, and technologies to pull more diagnostic data out of X-ray imaging. Some vendors also have redesigned their DR systems to make them more user-friendly and ergonomic. 
Feature | Digital Radiography (DR) | May 26, 2020 | By Dave Fornell
There were several new developments in digital rad...