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This document discusses the use of the drug misoprostol (brand name Cytotec) for cervical ripening and labor induction. It notes that Cytotec is not FDA approved for use in pregnant women and carries risks including amniotic fluid embolism, fetal bradycardia, hysterectomy, maternal or fetal death, pelvic pain, retained placenta, severe vaginal bleeding, shock, uterine hyperstimulation, and uterine rupture or perforation. The document is a treatment agreement that must be signed by both the patient and physician acknowledging discussion and consent to the off-label use of Cytotec for cervical ripening/induction of labor despite risks.
This document discusses the use of the drug misoprostol (brand name Cytotec) for cervical ripening and labor induction. It notes that Cytotec is not FDA approved for use in pregnant women and carries risks including amniotic fluid embolism, fetal bradycardia, hysterectomy, maternal or fetal death, pelvic pain, retained placenta, severe vaginal bleeding, shock, uterine hyperstimulation, and uterine rupture or perforation. The document is a treatment agreement that must be signed by both the patient and physician acknowledging discussion and consent to the off-label use of Cytotec for cervical ripening/induction of labor despite risks.
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Attribution Non-Commercial (BY-NC)
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This document discusses the use of the drug misoprostol (brand name Cytotec) for cervical ripening and labor induction. It notes that Cytotec is not FDA approved for use in pregnant women and carries risks including amniotic fluid embolism, fetal bradycardia, hysterectomy, maternal or fetal death, pelvic pain, retained placenta, severe vaginal bleeding, shock, uterine hyperstimulation, and uterine rupture or perforation. The document is a treatment agreement that must be signed by both the patient and physician acknowledging discussion and consent to the off-label use of Cytotec for cervical ripening/induction of labor despite risks.
Copyright:
Attribution Non-Commercial (BY-NC)
Verfügbare Formate
Als PDF, TXT herunterladen oder online auf Scribd lesen
This form is for reference purposes only. It is a general guideline and not a statement of standard of care and should be edited and amended to reflect policy requirements of your practice site(s), CMS and Joint Commission requirements, if applicable, and legal requirements of your individual state(s). C CY YT TO OT TE EC C (Misoprostol)
Misoprostol is a drug used to cause birth induction by uterine contractions and the ripening (effacement or thinning) of the cervix.
Patients Initials
_____ I am aware that Cytotec does not haveFDA approval for use in pregnant women. _____ I am aware that physicians have been using Cytotec for cervical ripening and for induction of labor, as an off-label use of the drug. _____ I am aware that Cytotec is currently contraindicated for use in pregnant women. _____ Alternative methods and therapies, their benefits, material risks and disadvantages have been explained to me. _____ I understand and accept that the most likely material risks and complications of Cytotec have been discussed with me and may include but are not limited to: amniotic fluid embolism fetal bradycardia hysterectomy or salpingo-oophorectomy maternal or fetal death pelvic pain retained placenta severe vaginal bleeding shock uterine hyperstimulation uterine rupture or perforation
_____ I have informed my physician of all previous surgeries. _____ I have informed the doctor of all my known allergies. _____ I have informed the doctor of all medications I am currently taking, including prescriptions, over-the-counter remedies, herbal therapies and supplements, aspirin, and any other recreational drug or alcohol use. _____ I have been advised whether I should avoid taking any or all of these medications on the days surrounding the procedure. _____ I am aware and accept that no guarantees regarding the use of Cytotec have been made by my physician. _____ I have been advised of the probable consequences of declining recommended or alternative therapies. _____ The doctor has answered all of my questions regarding Cytotec.
I certify that I have read and understand this treatment agreement and that all blanks were filled in prior to my signature.
I authorize and direct _________________________________, M.D., to administer the drug
Cytotec (Misoprostol) to me, _______________________________________, for the purpose of (patient name) cervical ripening/induction of labor.
_______________________________ _______________________________ Patient or Legal Representative Signature/Date/Time Relationship to Patient
_______________________________ _______________________________ Print Patient or Legal Representative Name Witness Signature/Date/Time
Continued
3/03 Revised 9/05, 12/05, 1/06, 6/07
This form is for reference purposes only. It is a general guideline and not a statement of standard of care and should be edited and amended to reflect policy requirements of your practice site(s), CMS and Joint Commission requirements, if applicable, and legal requirements of your individual state(s).
I certify that I have explained the nature, purpose, anticipated benefits, material risks, complications, and alternatives to the proposed procedure to the patient or the patients legal representative. I have answered all questions fully, and I believe that the patient/legal representative (circle one) fully understands what I have explained.