SAFETY OF IMAGING DURING PREGNANCY

Teratogenesis after radiation exposure

Organogenesis occurs predominantly between 2 and 15 weeks gestation. This is the

period when the fetus is most susceptible to the teratogenic effects of ionizing radiation,
which include microcephaly, microphthalmia, mental retardation, growth retardation,
behavioral defects, and cataracts. Teratogenic effects are extremely unlikely in fetuses
before 2 weeks of gestation and after 15 weeks of gestation [1]. The radiation dose
below which no teratogenic effects occur is not known, but is estimated to range from 5
to 15 rad [2]. The radiation dose to the fetus from a spiral CT study of the maternal
pelvis using typical technical parameters is 5 to 10 rad [3]. Therefore, the radiation dose
of pelvic CT is at the estimated threshold level for induction of congenital malformations.
In practice, studies have shown the incidence of malformations is not measurably
increased after in utero irradiation in humans [4].

Carcinogenesis after radiation exposure

The risk of childhood malignancy after in utero irradiation was first reported in 1956 [5],
though the association was not widely accepted until the early 1960s. The existing data,
derived from different sources, are relatively consistent. These data (which utilize
several different end-points) are shown below:

End-point Risk

Baseline risk of childhood cancer 19/10,000

Baseline risk of fatal childhood (0-15 yrs) cancer [6] 5/10,000

Excess risk of fatal childhood cancer per rad of fetal whole body dose [7] 4.6/10,000

Excess risk of childhood cancer per rad of fetal whole body dose [8] 6.4/10,000

Excess risk of childhood cancer per rad of fetal whole body dose [9]: 6/10,000

Relative risk of childhood cancer after fetal radiation exposure of 5 rad [10]: 2

Using a fetal dose estimate of 5 to 10 rad, this implies an increased risk of childhood
cancer of 2 to 4 times baseline for a standard pelvic CT. The relationship between the
risk of carcinogenesis and gestational age at the time of radiation exposure is more
controversial [11]. The OSCC study suggests the risk is higher with exposure in the first
trimester than with exposure in the second or third trimesters, with relative risks of 3.19,
1.29 and 1.30, respectively [12]. However, this may be an artifactual result, since

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radiographic studies in the first trimester may have included a disproportionately high
fraction of high dose non-obstetric studies such as IVPs and barium enemas. Also,
experimental work in dogs suggests exposure later in gestation is more carcinogenic
[13]. Nonetheless, the possibility of pre-malignant change in the first trimester remains,
leading the NRPB to assume that some risk exists after irradiation in the first weeks of
pregnancy.

Avoiding exposure in pregnancy

No law or professional standard requires that radiologists determine in advance whether

a patient of childbearing-age is pregnant [2]. However, it is clearly good practice to
implement the following guidelines:

Signs should be prominently displayed in all radiology departments asking each

patient to notify a technologist or physician if she is, or thinks she could be,
pregnant.

All technologists should ask women of childbearing-age if they might be pregnant

prior to performing a radiologic procedure.

Radiology requisition forms filled out by referring physicians should include a section
dealing with the possibility of pregnancy.

No radiological procedure involving exposure to the pelvis should be undertaken in a

patient who declares she may be pregnant without consultation with a radiologist.
The radiologist should discuss risks and benefits with the patient, and determine if it
is appropriate to proceed, perform an alternative procedure, or delay the study to
allow performance of a pregnancy test.

It should be noted that current recommendations do not recognize a safe period during
the menstrual cycle, and so the concept of the ten day rule is obsolete.

Managing pregnant patients who are irradiated

Relative agreement exists on when to recommend termination of pregnancy after

radiation exposure. The so-called Danish rule was offered in 1959 by Hammer-
Jacobsen, who suggested termination was advisable for a fetal dose of over 10 rads
[14]. This guideline has been widely followed. Wagner et al suggest termination should
only be considered if a radiation dose of over 5 rad occurs between 2 and 15 weeks of
gestation, and is probably indicated only for doses over 15 rad. Hall suggests
termination may be considered for a radiation of over 10 rad received between a
gestational age of 10 days and 26 weeks [15].

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In practice, it is exceptionally unlikely that any single radiological study would deliver a
radiation dose sufficient to justify termination. Nonetheless, it is helpful to be aware of
the expected radiation dose from common procedures [3, 16], and the magnitude of risk
to the fetus per unit dose. This information, which is listed below, can be used to
counsel pregnant patients who require a study involving ionizing radiation to the pelvis,
or who inadvertently undergo such a study at a time when pregnancy is unsuspected.

Procedure Conceptus radiation dose (rads*)

AXR 0.25

IVU 0.8

BE 0.8

L spine 0.6

CT pelvis 1-10

Note: 1 rad = 1 cGy = 10 mGy = 10,000 Gy

Iodinated contrast media in pregnancy

In general, intravascular contrast media should be avoided in pregnancy, in order to

avoid any possible hazard to the fetus. In vitro experiments have shown iodinated
contrast to be mutagenic to human cells [17]. Reassuringly, animal studies have failed
to show an in vivo teratogenic effect [18, 19]. The iodine content of contrast media has
the potential to produce neonatal hypothyroidism, and this has been observed after the
direct instillation of ionic contrast into the amniotic cavity during amniofetography [20].
The intravascular use of non-ionic contrast media has been reported to have no effect
on neonatal thyroid function [21].

Safety of MRI during pregnancy

The current guidelines of the FDA require labeling of the MRI devices to indicate that
the safety of MRI with respect to the fetus has not been established. Safety concerns
arise with respect to both mother and fetus. Maternal safety concerns are the same as
for a non-pregnant patient, and are addressed by pre-scan screening. Fetal concerns
are twofold; first, the possibility of teratogenic effects, and second, the possibility of
acoustic damage. Most studies evaluating MRI safety during pregnancy show no ill
effects [22-25]. However, a number of studies have raised the possibility of teratogenic
effects of MRI exposure in early pregnancy. A reduction in crown-rump length was seen
in mice exposed to MRI in midgestation [26]. Exposure to the electromagnetic fields

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simulating a clinical study caused eye malformations in a genetically predisposed
mouse strain [27]. Several hours of exposure of chick embryos in the first 48 hours of
life to a strong static magnetic field and rapid electromagnetic gradient fluctuations
resulted in an excess number of dead or abnormal chick embryos, when examined at
day 5 [28]. Possible mechanisms for apparent deleterious effects include the heating
effect of MR gradient changes, and direct non-thermal interaction of the electromagnetic
field with biological structures. Tissue heating is greatest at the maternal body surface,
and approaches negligible levels near the body center [29], making it unlikely that
thermal damage to the fetus is a serious risk. A possible criticism of many of these
studies is that they are not applicable to humans. However, they provide sufficient
cause for concern such that a cautionary approach should be taken regarding fetal MRI
in the first trimester. Accordingly, the guidelines of the National Radiological Protection
Board in the United Kingdom is that it might be prudent to exclude pregnant women
during the first three months of pregnancy [30]. An additional concern in the first
trimester is the underlying relatively high rate of spontaneous abortion in this period. An
MRI study could be coincidentally followed by a spontaneous abortion, but might give
rise to parental concerns regarding causal effect. From a practical viewpoint, first
trimester MRI will usually be performed for maternal rather than fetal indications, and in
this context MRI is still preferable to any imaging study involving ionizing radiation [31].
A less obvious concern is the potential risk of acoustic damage to the fetus, due to the
loud tapping noises generated by the coils of the MR scanner as they are subjected to
rapidly oscillating electromagnetic currents, especially with EPI, which is the noisiest
sequence in current clinical use. In a follow-up study of 18 patients who had undergone
EPI as fetuses, 16 passed their 8 month hearing test, compared to 16.7 expected [32].
In a second study, a microphone was passed through the esophagus into the fluid filled
stomach of a volunteer [33]. The aim was to simulate the acoustic environment of the
gravid uterus. The sound intensity in the stomach was measured during MRI scanning
across a range of radiofrequencies. The attenuation of the transmitted sound was
greater than 30 dB, sufficient to reduce sound intensity from near the dangerous level of
120 dB to an acceptable level of under 90 dB. The results of these studies provide
reassuring clinical and experimental evidence that there is no significant risk of acoustic
injury to the fetus during prenatal MRI. In summary, pregnant women in the second and
third trimester can be reassured that MRI poses no known risk to the fetus. Any hazard
appears negligible, and is outweighed by the possible diagnostic benefit of the study. A
more cautious approach should be taken in those cases where a MRI scan is required
in the first trimester. It should be noted that intravenous gadolinium is teratogenic in
animal studies, but at very high doses [34]. Nonetheless, intravenous gadolinium is
contra-indicated in pregnancy, and should only be used if absolutely essential, and only
after discussion of risks and benefits with the patient and referring clinician.

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1. References

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28. Yip YP, Capriotti C, Talagala SL, Yip JW. Effects of MR exposure at 1.5T on early
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29. Kanal E, Shellock FG, Talagala L. Safety considerations in MR imaging. Radiology
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34. Omniscan package insert, Nycomed, Princeton, NJ.

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