Safety of care
Could the patient be pregnant?
An article for physicians by physicians
Originally published March 2011
Certain investigations, medical treatments and surgical procedures are potentially harmful to a fetus. If a pregnancy is detected before any of these are started, then the physician and patient can have a meaningful discussion about the possible physical risks to the fetus, and the possible physical and emotional risks to the mother.
Risk management suggestions
Any physician contemplating an investigation or treatment for a female patient should consider the following:
- Is it possible the patient is pregnant? If it is a possibility, then has it been ruled out with an appropriate test at an appropriate time? Should the test be repeated during the course of the intervention?
- Have outstanding tests been reviewed?
- Has there been a discussion with the patient about the importance of effective contraception?
- Has the patient been informed of the risks and benefits of the proposed investigation or treatment for herself and the fetus?
- Are the limitations and sensitivity of the pregnancy tests known?
- If a female patient has been exposed to an investigation or treatment with the potential to harm a fetus and it is later discovered that she is pregnant, has there been a discussion with the patient to evaluate the risks and benefits of either continuing or terminating the pregnancy?
- Are protocols in place to address the possibility of pregnancy? If not, is there a need for protocols?
CMPA members should call the Association for advice if they have any medico-legal concerns regarding similar situations.
- Case review: From its medico-legal cases that closed between 2004 and 2010, the CMPA identified 19 cases related to pregnancies that were undiagnosed before investigations or treatments were ordered or performed. More about case reviews...
- Experts' opinions: The peer experts who reviewed the medical records in cases involving undiagnosed pregnancies had the following findings and observations. More about experts' opinions...
- Clinical scenario: A 27-year-old female was being treated by a gynecologist for cervical dysplasia and mastalgia. More about this clinical scenario...
Of the 19 cases, 11 were legal actions, one was a legal threat, and seven were medical regulatory authority (College) complaints. Of the legal actions and threats, six were dismissed and six were settled. The College dismissed one case but issued a caution or referred the matter to a committee in the remaining six.
The majority of physicians named in the study were obstetrician-gynecologists. Patients ranged in age from 15 to 39.
Nine patients underwent surgical procedures including laparoscopy, hysterectomy, IUD insertion, endometrial biopsy, and gastric banding; the remaining nine either underwent investigation or started medical treatment such as hormonal, dermatological, or chemotherapy.
One case was related to diagnostic imaging.
In three cases, a pregnancy test was done but the result was unknown to the most responsible physician prior to the intervention.
Five patients elected to continue their pregnancy; six chose therapeutic abortion; four miscarried; three were diagnosed at the time of hysterectomy, and one had an unknown outcome.
- Physicians lacked awareness of the hospital's policies requiring testing for pregnancy prior to starting certain investigations and treatments.
- Communication between health care providers about a patient's pregnancy status was inadequate.
- Documentation of the clinical evaluation, treatment options, and consent discussion was inadequate.
- There was a lack of awareness that there might be a significant delay between conception and a positive serum or urine pregnancy test. Even if a pregnancy test was performed, if a physician still suspected that a patient might be pregnant, he or she should have considered repeating the appropriate test.
- Before starting any investigations or treatments with the potential for teratogenesis or fetal harm, the possibility of pregnancy should have been assessed and the risks of becoming pregnant should have been discussed with the patient.
- Contraceptive methods should have been evaluated before any investigations or treatments were started. If the current method was not considered efficacious, alternatives should have been discussed with the patient.
- If contraception was stopped before an investigation or treatment was started, the physician should have considered discussing alternative forms of birth control with the patient.
- If the fetus had been exposed to a potentially harmful investigation or treatment, and the patient chose to proceed with the pregnancy, it may have been advisable to initiate appropriate investigations to assess the fetus on an ongoing basis. Consultation is often necessary.
Her gynecologist was aware that her only method of contraception was a spermicidal gel. They briefly discussed more effective birth control methods, which the patient declined. A recent Pap test demonstrated carcinoma in situ (HSIL) and the patient underwent a loop electrosurgical excision procedure (LEEP) with procedural sedation. Danazol (Cyclomen) therapy for the mastalgia was started three weeks before the LEEP procedure.
Six weeks after the procedure, the patient was seen in an emergency department with lower abdominal pain. An ultrasound showed a viable 15-week-old fetus. After a discussion with her gynecologist, the patient elected to terminate the pregnancy.
A legal action was launched against the gynecologist alleging failure to rule out pregnancy before initiating the danazol treatment and performing the LEEP procedure. Several peer experts stated that neither the LEEP procedure nor the procedural sedation posed significant risks to the fetus. However, they were uniformly critical of the following:
- The lack of a consent discussion on the risks of danazol.
- The decision to begin danazol treatment without checking whether the patient was pregnant.
- Not properly advising the patient of the importance of effective contraception.
In the absence of peer expert support, a payment was made by the CMPA to the patient on behalf of the member-gynecologist.