Microsoft word - metformin consent.doc

Consent for use of metformin in the preconceptual, and
post-conception period.
Metformin, also known as glucophage, is a medication used alone or in
combination with other medications to treat adults whose diabetes does not requireinsulin. It is thought to act by improving insulin binding thereby making the insulin thatis available more effective and reducing the level of insulin that is needed in circulation.
In the last ten years, the field of reproductive medicine has identified a relationship between polycystic ovarian syndrome (PCOS) and detectable elevations in
the amount of circulating insulin and plasminogen activating inhibitor-1 (PAI-1). PAI-1
inhibits the digestion of fibrin causing an increase in blood clot formation and fibrin
deposition. The use of metformin (as well as an amino acid called N-acetyl cysteine)
in women with PCOS has corrected elevated PAI-1 levels and reversed the
abnormal hormone levels associated with this condition.

The use of metformin prior to conception in women who do not ovulate on a
regular basis, such as is associated with PCOS, has been shown to produce regular
ovulation, menstrual cycles, and pregnancy
. This may be due, in part, to improved
insulin receptor binding of IGF-1 (insulin-like growth factor-1) in the ovarian follicle that
allows follicle stimulating hormone (FSH) from the brain to stimulate the follicle to
grow. Without treatment, a woman with PCOS is 3-5 times more likely to suffer
miscarriage and 2 times more likely to develop preeclampsia or pre-term labor. The
cause of these complications are as yet unexplained, however, excessive fibrin deposition
has been observed on the surface of the placenta in all disorders of reproduction,
including miscarriage, pre-term labor, pregnancy-induced hypertension, intrauterine
growth retardation, placental abruption, and stillbirth. This deposition of fibrin may
block blood flow and cause a compromise in the maternal-fetal exchanges that occur
across the placenta. Fibrin is a natural end-product in the clotting cascade that is
normally kept in check through a balance between the clotting cascade and the
fibrinolytic (fibrin digesting) pathways. Elevations in PAI-1, as is commonly seen in
PCOS, inhibit fibrinolytic pathways and may be a cause of the fibrin deposition seen in
the complications listed above. For these reasons, metformin is currently becoming a
mainstay in the treatment of PCOS and oligoovulation (infrequent ovulation).
At the moment, the most pressing issue is whether to continue to use
metformin once a pregnancy has been established. The package insert for
metformin categorizes it as class B drug suggesting that the merits of the medication
should outweigh the risks when used in pregnancy. This does not suggest that
metformin is teratogenic or harmful to a developing fetus, however, it indicates that
there is essentially no data to support the safety of its use during pregnancy.

During the past 10 years, experience has shown that PCOS patients who have been diagnosed with severe fibrinolytic imbalance benefit from the use of blood thinnerssuch as heparin. While heparin is safe to use in pregnancy, its action is to reduce the clotformation, not to remove or digest fibrin once it is formed. As a result, heparin is a poorchoice when treating the fibrinolytic disorder associated with PCOS. In addition,enormous amounts of heparin have been needed to keep clotting levels (aPTT) within anormal range. Heparin is also associated with bone loss and low platelet levels.
We recommend the use of metformin prior to conceiving and possibly also
during your pregnancy. Our recommendations are based on each individual situation
with consideration being given to such factors as fibrinolytic risk, history of pregnancy
loss, and past perinatal morbidity. Those women most likely to be advised to continue
metformin throughout the pregnancy are those who have demonstrated a significant
fibrinolytic disorder with elevated PAI-1, elevated soluble fibrin monomer, history of
infertility, oligoovulation, miscarriage, pre-term labor, preeclampsia, intra-uterine growth
retardation, placental abruption, or stillbirth. Ultimately, the decision is yours. You
should be aware that your obstetrician may not be comfortable with you taking
metformin during pregnancy and you may have to stop. There is no data to determine
what may happen when the metformin is stopped, perhaps, nothing.
Risks associated with taking metformin during pregnancy:
The decision to take metformin during pregnancy is not a capricious one.
The package insert states that metformin should not be taken during pregnancy.
There is virtually no data about the use of metformin in pregnancy.
The information that is available comes from South African and Dutch studies onnon-insulin dependent pregnant women who took metformin to control theirglucose levels (blood sugars) in pregnancy.
In 3 published studies, there were no reported fetal anomalies.
In one study, women taking metformin showed a higher incidence ofpreeclampsia than women taking insulin or sulfonureas.
In one pilot study, PCOS women who had experienced miscarriage in aprevious pregnancy showed a significantly reduced rate of early miscarriagewhen they took metformin during the first trimester of pregnancy.
Metformin can partially cross the placenta and therefore carries a theoretical risk tothe newborn to have low blood sugars after delivery. This potential problem can beavoided with appropriate planning: either stop metformin one week prior to yourexpected date of delivery, or, inform your pediatrician to monitor your baby s bloodsugar after delivery, so that intravenous glucose can be given if it is needed.
Simple risks associated with the use of metformin:
Diarrhea: usually occurs shortly after eating, especially if the meal contains a lot ofcarbohydrates.
Headaches: tend to occur initially, but resolve within a few days.
Lactic acid build-up or metabolic acidosis: This is serious and potentially fatalcondition. Symptoms include painful, burning muscles, stomach pain, severeheadache, confusion, and rapid breathing.
Death can occur from renal insufficiency or metabolic acidosis due to lactic acidbuild-up if metformin is not discontinued immediately. This is a very rareoccurrence.
No metformin prior to conception or after a positive pregnancy test.
Heparin, aspirin, and/or, superovulation.
I/We have read this consent and understand the information as it applies to me/us.
I/We have had the opportunity to ask questions and obtain answers in simple language.
I am/We are aware of the risks of not taking metformin (conception may be moredifficult and the risk of early miscarriage higher).
I am/We are aware of the known and theoretical risks associated with taking metformin.
I understand that there are no guarantees or warrantees implied or made by my doctor srecommendations.
I/We (do/do not) consent to taking metformin prior to conception.
I/We (do/do not) consent to taking metformin while pregnant.
I/We understand that I may be considered a high-risk pregnancy and may require closeobservation during pregnancy.
______________________________________Witness s signature



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