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AMNIOCENTESIS INFORMED CONSENT

PATIENT NAME: ______DATE: ______TIME: ______

The diagnosis requiring this procedure is: To determine whether there are detectable birth defects in this pregnancy or to determine the maturity of the baby’s lungs or to rule out infection in the amniotic fluid.

The nature of the procedure is: To withdraw a sample of the fluid surrounding the baby by inserting a needle through the abdominal wall into the uterine cavity.

The purposes of this procedure are

1. To determine whether there are birth defects detectable by the study of the amniotic fluid.

  1. To test for fetal lung maturity (whether the baby’s lungs are mature).
  2. To test for infection in the amniotic fluid.

This procedure involves the material risk of infection, allergic reaction, severe loss of blood, loss or loss of function of any limb or organ, paralysis, paraplegia or quadriplegia, disfiguring scar, brain damage, cardiac arrest or death.

ADDITIONAL RISKS: In addition to the material risks listed above, there may be other potential risks involved in this procedure including, but not limited, to the following:

  • Amniocentesis may, on occasion be followed by a miscarriage or fetal loss.
  • There is a possibility of injuring the baby with the needle.
  • Lack of success in withdrawing the fluid or lack of growth of the fetal cells in a culture. This would mean that the procedure would have to be repeated.
  • Leakage of fluid from the vagina. This may be blood tinged and is not considered to be a significant occurrence.
  • Due to the location of the placenta, it may be necessary to pass the needle through the placenta in order to obtain the fluid. This increases the risk of the procedure slightly.

The likelihood of success of this procedure is: good  fair poor

THE PRACTICAL ALTERNATIVES TO THIS PROCEDURE ARE:

Not to have the test done.

If I choose not to have the above procedure, my prognosis (future medical condition) is:

Not affected, however the baby may be delivered with undiagnosed birth defects/immature lungs, requiring treatment in the Neonatal Intensive Care Unit or death of the baby.

I understand that during the course of the procedure described above, it may be necessary or appropriate to perform additional procedures that are unforeseen or not known to be needed at the time this consent is given. I consent to and authorize the persons described herein to make the decisions concerning such procedures. I also consent to and authorize the performance of such additional procedures, as they deem necessary or appropriate.

I consent to diagnostic studies, tests, x-ray examinations and any other treatment or courses of treatment relating to the diagnosis or procedures described herein.

I consent to the use of sedation and/or anesthesia as planned by my treating physician. The risks, benefits and alternatives of such sedation/anesthesia have been explained to me. I understand that specific risks of anesthesia/sedation include, but are not limited to, changes in blood pressure, allergic reaction, difficulty breathing, cardiac or respiratory arrest, seizure, coma and death.

I consent to the use of blood and blood products as deemed necessary, both during and after surgery for this hospitalization. The risks of exposure to AIDS, hepatitis or other infectious diseases as well as the need for and available alternatives have been explained to me. (Cross through if this does not apply)

I consent that any tissues, specimens, organs or limbs removed from my body in the course of any procedure may be tested or retained for scientific or teaching purposes and then disposed of within the discretion of the physician, facility or other health care provider.

I understand that the physician, medical personnel and other assistants will rely on statements about the patient, the patient's medical history, and other information in determining whether to perform the procedure or the course of treatment for the patient's condition and in recommending the procedure which has been explained.

I understand that the practice of medicine is not an exact science and that NO GUARANTEES OR ASSURANCES HAVE BEEN MADE TO ME concerning the results of this procedure.

By signing this form, I acknowledge that the risks, benefits and alternatives to the above procedure have been explained to me, that I have read or had this form read and/or explained to me in general terms, that I fully understand its contents, that I have been given ample opportunity to ask questions and that any questions have been answered satisfactorily. All blanks or statements requiring completion were filled in and all statements I do not approve of were stricken before I signed this form. I also have received additional information, including but not limited to the materials listed below, related to the procedure described herein.

I hereby voluntarily request and consent for Dr. ______, as my physician, and any other physician(s), and such associates, assistants or other medical personnel involved in performing such procedure(s), to perform the procedure(s) described or referred to herein. I further consent to the presence of device or supply manufacturer’s representatives in the operating room as may be deemed appropriate by my physician.

Additional materials used, if any, during the informed consent process for this procedure include:

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Witnessed by:

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Responsible PhysicianPerson giving consent

Relationship to patient if not the patient:

______

Sequence #Patient unable to sign because:

Initiated 6/2001

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