Ab packet non surgical 020606.doc

Checklist for Non-surgical abortion Sono: W_____D _____ Patient name _____________________________ Chart # ________________ Patient meets inclusion & exclusion criteria _____________ Possible risk & complications explained Patient instructions & procedure explained _____________ Possible necessity of surgery procedure, In the event that non-surgical procedure 100 mg or 200 mg Mifiprex given to pt to swallow ___________, MD 800 mcg Cytotec given to pt to insert vaginally ___________, MD Patient given Rx for Tylenol #3 or Darvacet N100 20 tablets to take 1-2 tabs every 4-6 hours if needed for cramping Patient given Rx for Cipro 500mg, ____________, MD ___________ Single dose. Patient given Rx for Doxycycline 100mg, _____________, MD ____________ Bid x 7days, 14 tablets Pt told to return for exam on ______________ _______________ _______________ Documentation of patient follow- up phone calls: Medical abortion Inclusion and Exclusion Criteria Name________________________ Date___________ Chart # ________ Inclusion criteria (to qualify, patient must answer yes to all of the following: *sure of decision to terminate pregnancy *willing to have a surgical abortion if necessary *pregnancy no more than 63 days (9 weeks) gestation *agrees to: vaginal ultrasound, venipuncuture, pelvic exam *willing and able to sign informed consent *resident of the US and lives within 2 hours of the clinic *access to a telephone and emergency transportation Exclusion criteria (to qualify, patient must answer no to all of the following:
* acute inflammatory bowel disease yes no * insulin-dependent diabetes mellitus * adnexal mass or tenderness suggestive of PID yes no * ectopic pregnancy or threatened abortion yes no * 35 or older, smokers 20+ cigarettes a day, plus one other risk factor from the following: • Diabetes mellitus, hyperlipidemia, hypertension, family history of ischemic heart disease with * Desire to use any of the following medications: • Salicylates (such as aspirin), anticoagulants (such as coumadin), indomethacinindocin, oxytocics (methergine), antipsychotic medicatins (clozaril, compazine, haldow, mallaril, prolixin, stelazine, thorazine, trilafon) Patient signature _______________________________________ Witness ______________________________________________ CLINIC FORWOMEN
MEDICAL ABORTION TEACHING
Below are instructions for your medical abortion care. A medical abortion is available up to 8 weeks, 6 days
gestation. Please save this sheet to refer to if you have any questions. Call the clinic at 1-800-545-2400 if
you have questions. Our office hours are M-F 9:00am to 5:00pm, and Saturday 7:30am to noon. Our
answering service is available 24 hours a day to have a staff member paged.
Before Your Appointment - Patient Responsibilities
• Buy an easy to read thermometer and a box of sanitary pads.
• Arrive at the clinic at your scheduled time with your full payment.
• You may bring one support person only! (No babies or children please.) Waiting room space is limited.
You may be here 2 - 3 hours for your appointment. Please inform your support person of the wait. If you
prefer, you may come to the clinic by yourself.
Your First Clinic Visit
• You will have a vaginal ultrasound to determine eligibility for a medical abortion.
• A patient advocate will counsel you regarding the medical abortion procedure.
• After being checked in with the medical staff, you will see a doctor to take the Mifeprex. This medication
will cause the pregnancy to stop growing. Mifeprex works by blocking the action of progesterone, a hormone
needed to continue a pregnancy. It is used in combination with misoprostol, a drug that causes the uterus to
contract and expel the pregnancy. After taking Mifeprex the abortion has begun, so if you have any
reservations about your decision please be sure that they are adequately addressed ahead of time. You will
probably feel no different after taking the Mifeprex or the first medication. Bleeding, clotting, and cramping
usually do not occur until after inserting the second medication, misoprostol, into the vaginal canal. Rarely
(4% of cases) women will start to bleed and cramp before the misoprostol is inserted. You will be sent home
with 800 meg (4 tablets) of misoprostol. This medication is to be inserted into the vaginal canal 48 hours
after taking the mifeprex.
• You will also receive a prescription for a pain reliever: Tylenol with codeine. You may want to have your
prescription filled after you leave the clinic so it is available if you need it.
Your Medical Abortion
• Choose a time within the next 48 hours to take the misoprostol. Be prepared to spend this day and
possibly the next at home. You will insert the 4 tablets of misoprostol into your vagina. This medication
is not to be taken orally. (See misoprostol insertion instructions.) You should have someone with you who
is aware that you are having a medical abortion.
• Once the misoprostol is in your vagina you should relax for the next 8 hours. We suggest that you plan on
spending that day and possibly the next day at home. You should experience bleeding and cramping. About
50% of women who have used this method report cramping and bleeding similar to a heavy period. The other
half report cramping and bleeding worse than a heavy period. The heaviest cramping and bleeding usually
occur within a time period of 4-6 hours. . You may also pass large blood clots which could be up to the size
of a fist.
• Plan to take your temperature the day after inserting the misoprostol.
• If you have cramping in your lower abdomen you can take Tylenol (acetaminophen), Advil (ibuprofen),
Aleve (Naproxen Sodium), or Tylenol with codeine.
• Most women expel the pregnancy within 5 hours. 75% of cases expel within 48 hours. A minority of
women may take up to 14 days to completely expel the pregnancy.
• Some patients will experience nausea, vomiting, diarrhea, fever, headaches and chills. • These side effects could last up to two days. • No alcohol or aspirin until your next visit, as they may cause excessive bleeding. • Please watch for any signs of complication. If any of the following occur, please contact us immediately at 1-800-545-2400. 1. Soaking two or more pads per hour for 2 consecutive hours. Soaking means the complete saturation of a pad: front to back, side to side and top to bottom. 2. Having a temperature of 100.4 F. or higher the day after inserting misoprostol. 3. Severe abdominal pain not relieved by prescription pain medication. 5. No bleeding within 24 hours after inserting misoprostol. This may indicate that may need more medication or an evaluation for an ectopic pregnancy. Your Second Clinic Visit

• It is very important that you return to CFW within 6 to 8 days for a follow-up visit. During this
visit you will have a vaginal ultrasound to confirm that you are no longer pregnant and that there are no
complications. If the pregnancy is still inside the uterus, the physician will determine if you will need either a
second dose of misoprostol or a surgical abortion. You may need to return to the clinic a week later for a
repeat ultrasound if the exam is inconclusive.
• You may discuss birth control options with the staff at this time. If you decide to take birth control pills, we will give you a month's supply which you will begin taking the Sunday after your follow-up visit. If you do not return for your follow-up visit, the CFW will attempt to contact you by phone or
certified mail regarding the follow-up exam. It will be stated that the call is from CFW.

Activities
You may resume routine activities such as light housework, climbing stairs, attending classes, etc. as soon as
you feel like it. Avoid strenuous activities such as heavy lifting: do not lift 20 Ibs. or more, including
children. Avoid active sports such as tennis, horseback riding, bowling, etc. for a minimum of 14 days.
Resume activities slowly. If your bleeding or cramping increases with activity, restrict your activities for
several more days.

Preventing Infection

After inserting the misoprostol, do not put ANYTHING into your vagina for 3 weeks. This means no sexual
intercourse, no douching, no swimming, no tub baths, and no tampons. Use sanitary napkins/ pads instead of
tampons.

Menstrual Period
Your normal period should arrive 3-8 weeks after your abortion. Most women will ovulate 2 weeks before each period. The female fertility rate is extremely high following the end of a pregnancy. Remember that bleeding after the misoprostol should not be considered a period. Also, remember that your first period following the abortion may not be "normal" for you. MIFEPREX™ (Mifepristone) Tablets, 200 mg PATIENT A G R E E M E N T MIFEPREX* (mifepristone) Tablets 1. I have read the attached Medication Guide for using Mifeprex and misoprostol to end my pregnancy. 2. I discussed the information with my health care provider (provider). 3. My provider answered all my questions and told me about the risks and benefits of using Mifeprex and misoprostol to end my pregnancy. 4. I believe I am no more than 49 days (7 weeks) pregnant. 5. I understand that I will take Mifeprex in my provider's office. 6. I understand that I will take misoprostol in my provider's office two days after I take Mifeprex (Day 3). 7. My provider gave me advice on what to do if I develop heavy bleeding or need emergency care due to the treatment. 8. Bleeding and cramping do not mean that my pregnancy has ended. Therefore, I must return to my provider's office in about 2 weeks (about Day 14) afte r 1 take Mifeprex to be sure that my pregnancy has ended and that I am well. 9. I know that, in some cases, the treatment will not work. This happens in about 5 to 8 women out of 100 who use this treatment. 10. I understand that if my pregnancy continues after any part of the treatment, there is a chance that there may be birth defects. If my pregnancy continues after treatment with Mifeprex and misoprostol, I will talk with my provider about my choices, which may include a surgical procedure to end my pregnancy. 11. I understand that if the medicines I t a k e do not end my pregnancy and I d e c i d e to have a surgical procedure to end my pregnancy, or if I need a surgical procedure to stop bleeding, my provider will do the procedure or refer me to another provider who will. I have the provider's name, address and phone number. 12. I have my provider's name, address and phone number and know that I can call if I have any questions or concerns. 13. I have decided to take Mifeprex and misoprostol to end my pregnancy and will follow my provider's advice about when to take each drug and what to do in an emergency. 14. I will do the following: - return to my provider's office in 2 days (Day 3) to check if my pregnancy has ended. My provider will give me misoprostol if I am still pregnant. - return to my provider's office about 14 days after beginning treatment to be sure that my pregnancy has Patient Signature: _____________________________________Date: ___________________ Patient Name (print):___________________________________ The patient signed the PATIENT A G R E E M E N T in my presence after I counseled her and answered all her questions. I have given her the Medication Guide for mifepristone. Provider's Signature: ____________________________________Date:____________ Name of Provider (print):_______________________________________________ After the patient and the provider sign this PATIENT AGREEMENT, give 1 copy to the patient before she leaves the office and put I copy in her medical record. Give a copy of the Medication Guide to the patient. 9/28/00 * Mifeprex is a trademark of Danco Laboratories, LLC. Clinic for Women
3607 W. 16th St.
Indianapolis, In. 46222
I ______________________________give my permission for Dr.__________________and/or such associates s/he may elect and supervise to perform a nonsurgical/medical abortion with mifepristone and misoprostol. I understand that I am fewer than nine weeks pregnant, and I have decided to have an abortion with the medications Mifeprex and misoprostol. These medications will cause an abortion by starting vaginal cramping and bleeding similar to a very heavy period or miscarriage. This method allows a pregnant woman to have an abortion without putting instruments into the uterus. Mifeprex is a drug that blocks the action of progesterone, a hormone needed to continue a pregnancy.
Misoprostol is a drug which causes the uterus to contract and empty. When the EDA approved Mifeprex, it
was approved for use in combination with misoprostol. Studies have shown that Mifeprex and misoprostol,
when used together, are approximately 95% effective in causing an abortion in an early pregnancy.
Procedure:
This procedure follows the evidence based regimen- a process that has been thoroughly studied during the
past two years and allows the patient to complete her nonsurgical abortion using less medication than the
PDA regimen. The evidence based regimen has been proven effective, is less expensive, and has fewer side
effects- particularly stomach upset and diarrhea.
• After a thorough medical history I will have an ultrasound to confirm the gestation of the pregnancy to make certain it is less than 9 weeks. • The physician will review my history, ask any questions s/he has, and may perform a pelvic • The physician will give me one 200 mg. Mifeprex tablet to swallow while here in the facility. • I will be given 4 misoprostol tablets with instructions to insert them into the vagina at home between 48 and 72 hours after taking the Mifeprex tablet. • I will plan to stay home for approximately 6-8 hours after inserting the misoprostol tablets into my vagina. I can expect to have moderate to severe cramping and vaginal bleeding in the hours following the insertion of misoprostol. • I will contact my provider at 1-800-545-2400 if I soak one maxi pad per hour for two consecutive hours. 1 will take my temperature daily and contact the Clinic for Women if it exceeds 100.4 degrees. • If I have severe abdominal cramping, I know that 1 can take pain medications • If the cramping persists, I can fill and take the prescription for Tylenol with • I will return to the clinic within 6-8 days for my second visit for the purpose of having a vaginal ultrasound. If the ultrasound is negative, I will be provided with a urine pregnancy test to be administered at home two weeks following the ultrasound. I will notify the clinic with the results, be it negative or positive. • If the pregnancy has not been terminated, I understand that I will need to have a Risks may include:
Incomplete abortion As with surgical abortion, some pregnancy tissue may remain in my uterus. If this occurs, the provider will discuss my treatment options, which may include a surgical abortion. The risk of having very heavy vaginal bleeding after using Mifeprex and misoprostol is about 1/100 or 1%. The risk of needing a blood transfusion after using these medications is about 1/1000 or 0.1 %. Continued pregnancy and birth defects My pregnancy may not end after receiving the medications. If this happens, birth defects are possible. Because of the risk of birth defects, I know that a surgical abortion is strongly recommended to end the pregnancy. The risks of a first-trimester surgical abortion include perforation of the uterus, tearing of the cervix, an adverse reaction to any anesthesia used, infection, excessive bleeding, and failure to remove all of the tissue from the uterus. Side effects The following side effects are possible: nausea, vomiting, diarrhea, fever, headaches, and chills. Most of these side effects last less than a day. I will have cramping in my lower abdomen and I may need pain medication for this reason. Ectopic pregnancy or a pregnancy outside the uterus is a rare condition. It is a complication of pregnancy rather than abortion. I understand that if the pregnancy is in the fallopian tube or outside the uterus, neither surgical abortion nor Mifeprex/misoprostol abortion will remove the pregnancy. Due to the possible threat of rupture of the fallopian tube, hospitalization may be necessary as soon as it is discovered. I will receive medical care for my abortion as described above and information about birth control at a charge of $________. This fee includes payment for a surgical abortion if needed. The fee does not include charges for an emergency room visit or for care at another facility. Voluntary Consent
I have been informed of other choices during early pregnancy including continuing the pregnancy and becoming a parent, continuing the pregnancy and making adoption arrangements, and surgical abortion. I have been informed of the risks involved with a surgical abortion and a medical abortion, and the risks involved with continuing the pregnancy. I understand that I may choose to have a surgical abortion at any time after I start the medical abortion, although I will need to pay for this care if it is not medically necessary. I have fully disclosed my medical history including the date of my last menstrual period, allergies, blood conditions, prior medications or drugs, and reactions to medications or drugs. I certify that I have read this form or it has been read to me. I understand its contents, and any questions have been answered to my satisfaction. I certify that 1 have been given the Mifeprex Patient Agreement and that I have had an opportunity to read it and discuss it with my provider. ________________________________________ ________________________________________ Print Patient's Name and File Number _______________________________________ Instructions for Using Vaginal Misoprostol in Medical Abortion
Some women bleed after taking mifepristone. However, in almost all cases you must use the second medication,
called misoprostol, to complete the abortion. You should use the misoprostol even if you have had bleeding after
taking mifepristone in our office. You will insert 4 misoprostol pills into your vagina. You should use the
misoprostol any time between ___________________and__________________.
(time and date (time and date)
Preparation:

Most women will experience cramping and bleeding within a few hours of inserting misoprostol. The cramping
and bleeding are usually heavier than what you might have during your period. Cramping may start before the
bleeding. Some women expel blood clots that range in size from small (the size of a quarter) to quite large (the
size of a lemon). The bleeding usually decreases after the pregnancy is expelled. About 90% of women expel the
pregnancy within 24 hours of taking vaginal misoprostol. Other side effects that may occur after using
misoprostol include: nausea, vomiting, diarrhea, warmth or chills, headache, and tiredness. These side effects
usually last for a fairly short time and go away on their own. Because of these side effects, it may be a good idea
to insert the misoprostol when you have several hours with no other responsibilities. You will also want to have
plenty of large maxi pads, as well as medication for pain, and other comfort measures, such as a heating pad, hot
water bottle, and warm liquids, ready before you insert the misoprostol. Be sure to drink plenty of non-alcoholic,
caffeine-free beverages (e.g. water, juice, sports drinks) to avoid dehydration.
Some women find that it helps to have a partner or friend with them when they use the misoprostol. Some
women may prefer to have privacy, but have someone they know they can reach if they need help. While it is
rare to have an emergency, it is important that you make plans ahead of time about how to call us and how you
would get to our office or another medical facility if you needed to.
How to Insert the Misoprostol:

1. Empty your bladder.
2. Wash your hands.
3. Push the four misoprostol tablets one at a time up into the vagina as far as you can
4. Your health care provider may recommend that you lie down for about 30 minutes after you insert the Sometimes the tablets come out when your bleeding starts or if you are up and about. If the tablets fall out while you are bleeding, do not worry. In most cases, enough of the medication will have been absorbed. If the tablets fall out before your bleeding starts, you may reinsert them or call us for instructions on what to do. Some women wonder if they will see pregnancy tissue as they bleed. You may see a sac that is white or grayish and looks somewhat like a grape. You may see only blood clots. Typically, the embryo is not visible before about 8 '/z weeks of gestation. Call Us If:
1. You are soaking through two or more large maxi pads each hour for 2 hours in a row, or the bleeding seems heavier than you expected. 2. You have severe pain and pain medication is not helping. 3. You have severe diarrhea or vomiting that lasts several hours 4. You feel faint, lightheaded, or dizzy. 5. You have a fever of 100.4°F or more that lasts several hours. 6. You have a fever that starts a day or more after you take misoprostol. If you have any concerns or questions, please contact us at ______________________. There is someone available to answer your call 24 hours a day. The Days After Using Misoprostol:
You may have some bleeding or spotting for several more clays or a few weeks after using misoprostol. Most women find that their pregnancy symptoms decrease. While you can return to your normal activities, you may be more tired than usual for a few days. You might want to avoid strenuous activities or exercise until your follow-up visit. You can get pregnant very soon after an abortion, even before your next period comes. Most providers recommend that you not have intercourse until after your follow-up visit. Your provider will advise you how and when to begin contraception to avoid unintended pregnancy. Follow-up Visit:
Your follow up visit is scheduled for __________________________ . It is very important for you to return to the office for a check-up to make sure that the abortion is complete. For some women, even if they have had bleeding, the abortion may not be complete. The only way to know for sure is to come back for a check-up. If the pregnancy is still growing at the time of your follow-up visit, it is strongly recommended that you have a surgical abortion (using suction) because the medication can cause birth defects in this pregnancy if it continues. We can also provide you with contraceptive information and arrange for you to have the contraceptive method(s) of your choice at the time of your follow-up, if we haven't done so at your first appointment.

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