(1) EARLY VACUUM ABORTION (EVA) from 3 to 6 wks LMP
(2) MEDICATION ABORTION from 4 to 10 wks LMP using mefipristone (RU-486 abortion pill, brand name is Mifeprex) and misoprostol (Cytotec)
On September 28, 2000 the FDA approved a medicine called mifepristone (Mifeprex), which is also known as RU-486, to end early pregnancy. Initial studies determined that medication abortion works up to 49 days LMP. Base on subsequent studies, the limit has been extended to 70 days LMP.
The original FDA-Approved labeling consists of oral mifepristone 600 mg followed by oral misoprostol 400 micrograms.
The Evidence-Based Alternative Regimen is the currently accepted standard of practice.This regimen is as effective as the FDA-Approved labeling
(a) The dose of Mifepristone is 200 mg (one tablet) instead of 600 mg;
(b) Misoprostol is now administered at home, which is safe, effective and highly acceptable to patients
(c) Misoprostol is administered between 6 - 48 hours after the mifepristone. Lesser than 6-8 hr interval may be associated with up to a 4% loss of efficacy.
How does medication abortion work?
There are three Steps
Step One: our clinician will give you a 200 mg dose of mefipristone in tablet form.This medication blocks the hormone progesterone, causing the lining of the uterus to break down and end the pregnancy. However, the use of mifepristone alone is not effective. You must take the second step.
Step Two: 6 to 24 hr after the mefipristone, you must use a medication called misoprostol in tablet form which causes the uterus to contract and empty, as with a miscarriage. This may feel, to you, like having a heavy period.
Step Three: is your follow-up ultrasound exam in two weeks, to make sure the abortion is complete.
How long does it take?
The process of medication abortion begins immediately after using mifepristone. Some women begin spotting before taking the misoprostol. For most, the bleeding and cramping associated with medication abortion begin after taking misoprosol. After you take the misoprostol you will start to bleed heavily within hours or days. This heavy bleeding usually is the abortion. Heavy bleeding may continue for about 14 days or longer. Spotting can continue for a few more weeks.
How effective is it?
In the single largest trial of medication abortion, the combination mifepristone/misoprostol was 95% effective. This was much better than the 60% effectiveness rate of methotrexate, which is the alternative drug to mifepristone.
Complete abortion occurred within 24 hours after the misoprostol in 90% of patients. More than 50 percent of women will abort within four to five hours after taking misoprostol.
Administration of misoprostol may be buccal (you tuck the 2 tablets of misoprostol on each side of the mouth, between the cheek and gum); sublingual (by placing the tablets under the tongue); vaginal (all the misoprostol tablets must be inserted deeply into the vagina); or oral (the tablets are swallowed immediately).
When misoprostol is used vaginally or sublingually, the gestational limit can be extended to 10 weeks LMP and the medications can be administered as little as 6 to 8 hours apart. Some institutions do not recommend exceeding the limit of 7 weeks LMP because of the increased rate of failures and other complications such as excessive bleeding and infection.
The buccal or sublingual route of misoprostol may be safer than the vaginal administration because of the risk of infection. Infections are rare but may be fatal.
Compared with the vaginal use of misoprostol, the buccal or sublingual route may be associated with more side effects such as nausea, vomiting or diarrhea. However, recent studies have shown that the rates of reported side effects with 400 micrograms (2 tablets) of sublingual misoprostol appear comparable to those associated with regimens using 800 micrograms (4 tablets) of vaginal misoprostol without a significant decline of efficacy.
The interval between mifepristone and misoprostol must be extended to 36-48 hours if the misoprostol is used orally. We do not recommend using misoprostol orally.
What do I need to do to have a medication abortion?
During the first visit, you will need to have counseling, give a medical history, have laboratory test, sign the consent forms, and have a physical exam - including an ultrasound. You will also be given a medication guide to take home with you. You will take the first medication at the clinic. We will provide you with four tablets (800 mg) of misoprostol, oral doxycycline (an antibiotic) and pain pills. If you have prescription insurance coverage, we will give you the prescription for you to fill at the pharmacy.
Why do some women prefer medication abortion?
Women who choose medication abortion usually prefer to get their abortion at home, without having a procedure in a clinic and without anesthesia. Some of these women may feel "more in control"; or may feel better "because of the way it is carried out". Some prefer a medication abortion because it seems that it is less invasive and more natural, like a miscarriage or like having a heavy period. Some women may dislike the idea of “having a procedure” because of moral opposition to abortion.
Women that choose medication abortion are willing to risk the higher rate of bleeding, pain, failed abortion and time loss.
Women are not optimal candidates for medication abortion if they wish to minimize their participation in the abortion; are anxious to have the abortion over quickly and are unwilling to wait for the miscarriage to occur; do not have someone else at home that knows what is happening; do not have a telephone available; or have language barriers that may interfere with her communicating with her doctor; or do not have the ability to deal with emergencies during the first 2 or 3 weeks. We strongly advise that a support person be with the patient or at least be close by and has the means of quickly transport her within the hour to a hospital or to our clinic in the event of hemorrhage or some other emergency.
Medication abortion should be used with caution in women with a serious illness, such as active liver disease, sickle cell or severe anemia, severe heart disease, uncontrolled seizure disorder, Immune Deficiency Disorder/ HIV, or diabetes that is not well controlled; or in women that would find it unacceptable that products of conception and/or clots may be passed at an inconvenient time or place; are unwilling to stop breastfeeding for seven (7) days after the abortion pill; have active alcohol/drug addiction; or have severe vomiting (hyperemesis) or other conditions that cause nausea, vomiting or diarrhea which may be aggravated by misoprostol..
Some women should not have a medication abortion. This includes women who: (a) have a pregnancy that on ultrasound is past 10 wks LMP; (b) have a pregnancy of uncertain location (PUL) particularly if there is no visible gestational sac on ultrasound; have a suspicious pelvic mass, signs or symptoms of a possible ectopic pregnancy; ( c) have an intrauterine device (IUD) in place that will not be removed without invading the uterine cavity (for example, if the IUD string is not visible). However, the medication abortion can be performed if the IUD string is visible and the IUD is first removed; (d) have a bleeding disorder (coagulopathy); (e) take an anticoagulant drug to thin their blood; (f) take certain steroid medicines; (g) have chronic adrenal failure; (h) would not agree to have a vacuum aspiration abortion if the medication abortion fails; (i) do not have access to a telephone, transportation, or back-up medical care. Asthma is not a contraindication
What are the risks and possible complications?.
In rare situations (less than 1%), very heavy bleeding (defined as soaking one pad per hour for longer than 12 hours) and/or severe pain may occur. These symptoms may require hospitalization for emergency D&C or for additional treatment.
Patients are hereby advised that any medical services or tests not received at the All Women's Clinic, including hospital or emergency room care, will be the patient's financial responsibility and at her own financial expense.
Women may rarely experience a delayed second episode of heavy bleeding which may occur several weeks to months after initial medication abortion. This event is distinct from the more commonly experienced heavy first menses which may occur after either a medication abortion or a vacuum abortion.
Infection: In large clinical trials, the infection rate is approximately 0.9%.
Fatal infections with Clostridium sordelli and Clostridium perfringens that have been reported in North America are rare. Serious infections may persist after expulsion of the pregnancy and include weakness, nausea, vomiting, or diarrhea with or without abdominal pain. Patients typically lack a fever but have rapid pulse, low blood pressure and very high red and white cell counts.
Medication Abortion has a 5 - 8% failure rate which may require having a suction curettage either because of ongoing or excessive bleeding; an incomplete abortion (tissue remaining in the uterus but there is no growing embryo); or an ongoing viable pregnancy (a growing pregnancy which occurs in less than 1% of cases).
We will provide the suction curettage at the All Women's Clinic at no additional charge.
Patients are precluded from changing their mind after taking the medications, even if the medication abortion fails due to drug failure. The abortion must be surgically completed because these medications may cause congenital malformations.
Compared to EVA, the bleeding and cramping with a medication abortion may be more severe, and may be comparable to a heavy menstrual period because the woman is having a miscarriage. Bleeding, cramping and passing clots are a normal part of the medication abortion process. However, some patients say that their bleeding wasn’t as heavy as expected. Bleeding and/or spotting lasts on average 9-16 days but may continue for as long as six weeks.
EVA offers the following advantages over Medication Abortion:
a) EVA will efficiently complete the abortion in a matter of minutes - in a single-step office visit - and entails less time lost from work and other activities than medication abortion, which may take days or even weeks to be completed.
b) the rate of failed abortion is practically zero when a gestational sac is visible on ultrasound. The ultrasound may be performed before and after the suction- while the patient is still on the operating table - to immediately verify the success of the procedure and prevent abortion failures. In comparison, the failure rate with medication abortion is 5-8% The failure is usually discovered by ultrasound, after 7 - 14 days.
c) EVA provides more certainty to the question of an undiagnosed, early ectopic pregnancy. Medication abortion carries a higher probability of missing an ectopic pregnancy because it relies only on the ultrasound which, in some early pregnancies, is not diagnostic. Ectopic pregnancy may be accompanied by an intrauterine decidual reaction that may mimic the appearance of an early uterine gestational sac; and similar images may be present in non pregnant patients with infections, myomas and/or bleeding disorders. If the ultrasound exam is not diagnostic of uterine pregnancy, the patient may require to have two blood hCG titers performed 3-4 days apart from each other to verify that the pregnancy has been terminated and is not an ectopic pregnancy.
d) EVA can be performed earlier - even when a gestational sac is not found on ultrasound - as long as we confirm the positive pregnancy test. In comparison, the medication abortion must be cancelled if a visible ultrasound gestational sac is not found, because neither mifepristone nor misoprostol are effective in treating ectopic pregnancy.
e) Patients may experience less bleeding or pain; and recover faster after an EVA. EVA is performed under intravenous moderate sedation that enhances the patient's comfort and decreases her recollection of the events surrounding the procedure.
Before choosing to have a medication abortion, you and the counselor will discuss the Patient Information Notebook and other documents explaining to the pros and cons of medication abortion versus aspiration (vacuum) abortion.
Please be advised that you will be given the Evidence-Based Regimen which is different than the FDA-Approved labeling, as discussed earlier.
On the first visit (Day 1) the doctor will do a sonogram to accurately determine the stage of pregnancy; perform blood work; administer you with a shot of Rhogam if your blood type is Rh-negative; have you swallow one pill of Mifeprex; and provide you with four small misoprostol tablets to take home. The next day (Day 2), you will tuck the 4 tablets of misoprostol between the cheek and gum (buccal administration), or under the tongue (sublingual administration). Any remnants of the tablets are to be swallowed after 30 minutes. You can have a meal one hour after taking the misoprostol. Since you can expect cramping and bleeding and perhaps vomiting and dearhea, and a rise in temperature, you should drink plenty of fluids and eat lightly and avoid spicy or fried foods the day before and the day you use the misoprostol tablets.
The recommended dose of mifepristone is one 200 mg tablet followed 24 hours later by 800 micrograms (4 tablets) of buccal misoprostol. Given buccally, the four mifepristone tablets are tucked between the cheek and gum, two tablets on each side of the mouth. Alternatively, 400 micrograms (two tablets) of misoprostol may be placed sublingually (under the tongue). The tablets are allowed to dissolve in place for 30 minutes after which the remaining fragments are swallowed.
The interval between mifepristone and misoprostol must be extended to 36-48 hours if the misoprostol is used orally and is swallowed immediately. We do not recommend administering misoprostol this way.
Stay at home at least 8 hours after using the misoprostol. The mayority of women will have miscarried in 8 hours but it may take longer. If you have children, someone must be able to watch your children for you.
You may use Ibuprofen 800 mg every 4 hours for pain relief. Do not exceed three ibuprofen tables within 24 hours.
If you do not have substantial bleeding, you will need to come back for a visit and repeat the dose of misoprostol in 24 hours. If you fail to bleed after the second dose of misoprostol, you should promptly return for another visit because this may indicate that you may have an undiagnosed ectopic pregnancy.
Call us if you soak more than two maxi pads an hour or pass clots larger than lemons for two hours in a row; bleed heavily for more than 12 hours in a row; run a temperature over 100.4 degrees for more than four hours; feel strong nausea or throw up for more than four hours; are in pain, even with painkillers; or have an allergic reaction to the medicine. In case of a medical emergency, or if you can not reach the clinic, call 911 and report to the closest hospital emergency room.
YOUR FOLLOW UP EXAM
It is very important that you come back in two weeks for a repeat vaginal ultrasound to find out if the medication abortion was successful or not. The importance of the follow-up visit to confirm complete abortion can’t be stressed enough, because of the possibility of a continued pregnancy in the absence of bleeding (or even after bleeding); and the risk of fetal malformations after using misoprostol and doxycycline during the first trimester of pregnancy.
INFORMED CONSENT TO ABORTION WITH MIFEPREX (MIFEPRISTONE or RU-486) AND CYTOTEC (MISOPROSTOL)
1) I, (print name of patient)_________________________________, age______, request and consent of my own free will to the performance upon me of a medication (chemical) abortion at home, under the direction of Theodor Lehrer, M.D. or by an associate designated by him at the All Women’s Clinic located at 2100 East Commercial Blvd, Fort Lauderdale, Florida.
2) I have read and understand the Abortion Fact Sheet, the Mifeprex Medication Guide and the Patient Agreement forms; had a private opportunity to have all my questions answered to my complete satisfaction; and have discussed with a counselor the risks of the drugs mifeprestone and misoprostol when used to terminate a pregnancy and cause a miscarriage; the alternative use of methotrexate instead of mifeprestone; and the alternatives to medication abortion, namely, Early Vacuum Aspiration (a mini-suction curettage); suction curettage (if I choose to delay the procedure a few weeks); parenting; adoption; or foster care. I understand that the most accepted procedure to terminate a pregnancy is suction curettage which, compared to the 95% effectiveness rate for medication abortion, is over 99% effective. Also, suction abortion is more efficient and has a faster recovery time. For a comparison of the advantages and disadvantages of the various techniques for early pregnancy termination, I agree to read about it at allwomensclinic.com and in the Abortion Fact Sheet. I understand that I can reschedule my appointment and/or return for additional counseling if I feel extreme indecision or severe conflict regarding choosing the best option regarding this pregnancy. I understand that the length of an early pregnancy is best determined by a vaginal sonogram.
3) I have been advised it would be unsafe to get a medication abortion if I have any of the following conditions: (a) if my pregnancy exceeds 49-63 days, depending on the protocol being used; (b) if my pregnancy is, or may be, outside of the uterus (For instance, if the preliminary sonogram shows no intrauterine gestational sac or I have an undiagnosed adnexal mass, vaginal bleeding or pain); (c) if I have an intrauterine device , unless the device is removed before taking Mifeprex; (d) if I have chronic adrenal failure or have been chronically taking corticosteroids; (e) if I have inherited porphyria; (f) if I have a bleeding disorder or currently use anticoagulant therapy; (g) if I am allergic to mifepristone, to misoprostol, or to medicines that contain misoprostol, such as Cytotec or Arthrotec; (h) if I am unable to return to All Women’s Clinic for follow up visits or for additional care; (i) if I cannot get medical help during the first two weeks after taking Mifeprex, for any reason such as not having a telephone, not having immediate access to transportation 24-hours a days, living more than two hours away from All Women’s Center and/or more than one hour away from a 24-hour Emergency Room; (j) if I currently misuse or abuse alcohol and/or recreational drugs; (k) if I would not agree to get a surgical suction abortion if the medication abortion fails. I hereby state none of the above conditions or circumstances apply to me.
4) If I am eligible for a medication abortion, I agree to use the evidence-based regimen that modifies the FDA-approved regimen that is outlined in the Patient Agreement. I understand that I will be prescribed the evidence-based regimen that follows because it is safe and effective and it is associated with less stomach upset and less expense than the FDA-approved regimen. On Day-1 (today) I will take Mifeprex 200mg (1 tablet) orally; and on Day-2 (tomorrow) I will use 4 tablets of misoprostol (Cytotec) as instructed by my doctor, either vaginally or buccally (by placing for 30 minutes two tablets of misoprostol on each side of my mouth, between my teeth and my cheek and then swallowing the residual medication with water). On day 14, I agree to return for a pelvic exam and a sonogram free of charge to make sure that the abortion has been successfully completed. If advised by the physician, I also agree to have additional follow up visits and blood testing, if indicated. I understand that these tests may result in additional cost to me. If I am found to have Rh negative blood, I also agree to receive today an injection of anti-D immune globulin and to pay the additional charge for this medication that is listed under the service fees.
5) I understand that the drugs Mifeprex and misoprostol will cause an abortion by producing uterine contractions; and that I will experience cramping and vaginal bleeding which may be similar or heavier than a prolonged heavy period. I understand that I may pass large clots without passing the pregnancy tissue; the bleeding may last as long as six weeks; and the cramping or pain may be severe. In rare but possible situations, heavy bleeding may require blood transfusions and an emergency surgical abortion in a hospital setting. Other medical complications that may require emergency treatment and/or hospitalization may include, but are not limited to, allergic reactions; infections of the uterus, tubes and/ or ovaries; and incomplete abortion. Any of these complications may be severe and very rarely may cause seizure, multi-organ failure, cardiac arrest and/or death. Other possible side effects which usually last less than a day are nausea, vomiting, diarrhea, fever, headaches, and chills. I will contact my provider at 954-772-0933 if: I soak 2 or more maxipads per hour for two consecutive hours, or 1 pad per hour for longer than 12 hours during or after the miscarriage process; I have no bleeding within 24 hours after misoprostol; I have a fever (100.4°F) or if a fever starts a few days after using misoprostol, which may be due to infection; I have severe abdominal pain not relieved by pain medication; and/or I have severe and persistent vomiting or diarrhea. Any of the above may require additional medications or evaluation. I understand that any medical services or tests not received by All Women’s Clinic, including hospital or emergency room care, will be of my responsibility and my own financial expense.
I acknowledge that no guarantee has been made to me as to the results of the medication abortion or a surgical abortion and that complications may arise which may require additional treatment or hospitalization which will be at my own expense.
6) I understand that I may pass the embryo from 24 hours to four (4) weeks after the start of the bleeding, at an unpredictable or inconvenient time or place, and that I may see the embryo. I also understand that following a medication abortion, I may experience many emotional reactions, feelings, and thoughts, including but not limited to emotional distress, regret, grief, loss, ambivalence, flashbacks to the abortion, guilt, anxiety, and depression, as well as relief, self-empowerment, closure, and self-affirmation. I understand these emotional reactions may be short-term or long-term. I further realize that these varied feelings may be normal and also may occur after a woman delivers a baby. I agree to contact All Women’s Clinic for counseling and/or referral should these feelings persist and become difficult for me to cope with.
7) I understand that approximately 5% to 8% of the time, a medically-induced abortion fails to terminate the pregnancy; and that both Mifeprex and misoprostol can cause severe birth defects. I agree to have a surgical suction abortion without delay in the event of failure of the medication abortion. If, against medical advice, I decide to carry the continued pregnancy to full term, I agree to release All Women’s Clinic’s staff and physicians from any and all liability and responsibility of any nature whatsoever which may result from the costs, expenses or complications of childbirth or from the birth of an infant or infants normal or abnormal in any respect, including but not limited to the costs of child-rearing and medical care. A surgical suction curettage is required in about 5% to 8% of patients undergoing a medication abortion, when the chemical abortion fails and the pregnancy continues; or if incomplete abortion or excessive bleeding occurs. I have been provided with an informed consent for abortion by suction curettage; understand its risks and side effects; and agree to have the surgical abortion procedure without delay, should it become indicated by the physician at All Women’s Clinic.
8) I understand that I may be carrying an undetected ectopic pregnancy (a pregnancy outside the uterus, most commonly in the fallopian tube) which may later rupture (burst) and may require emergency surgery at the hospital with removal of the involved tube or ovary and blood transfusions. I acknowledge having received the list of warning signs and symptoms of a ruptured ectopic pregnancy (sharp or severe abdominal pain, shoulder pain, fainting, dizziness, abdominal distension). If I notice any of these signs or symptoms, I acknowledge having been instructed to call 911 and to report to the nearest emergency room. For Emergency Services the Center is available 24-hours a day, 7-days a week. When you call, we may ask you for the phone number of your nearest pharmacy, so please first make sure that the pharmacy is open. Our doctor has staff membership at Broward General Hospital. I acknowledge receiving instructions on how to contact All Women’s Clinic at its 24-hour Hotline 954/772-0933 or toll free at 1-800-867-1693. I am fully aware that the most up-to-date information on medication abortion and follow up instructions are available 24 hours a day at the All Women’s Clinic website www.allwomensclinic.com.
9) In order to ensure the best possible care, I authorize All Women’s Clinic, LLC to release my medical records to any other provider of medical services that I may need as a result of this abortion procedure. I also authorize any provider of medical care that may be necessary after my abortion to release my complete records to All Women’s Clinic, LLC.
10) I understand that this Informed Consent is a legal document, which is binding upon me. This document reflects my personal choices. If any part of this document is held invalid, I desire and agree that all other parts shall continue in force. I certify that I have read, or have had read to me, and fully understand the information in this Informed Consent Form and in all the forms that I have signed. The explanations therein referred to were made to me and all blanks or statements requiring insertion were filled in. I accept responsibility for ensuring that all my questions are answered to my complete satisfaction before the termination of pregnancy is performed. My signature also attests to the fact that I voluntarily accept the risks associated with the medication abortion or with the surgical termination of my pregnancy.
Patient Signature ____________________________________________ Date ___________________________
I witness the fact that the patient received, read and said she understood the above referred documents:
Witness Signature ___________________________________________ Date ___________________________
I hereby authorize and release Theodor Lehrer, M.D., his associates and staff, to transmit my records for review to: ________________________________________________________________________________________________________
Patient Signature ________________________________________________ Date __________________________ Translated by ______________________________________________ Check mark if no need for translation _________ CONTRACEPTION AFTER THE MEDICATION ABORTION
Contraception may be safely initiated at any time after a medication abortion, preferably on the first Sunday after taking misoprostol.
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You may contact All Women's Clinic at any of the following numbers: Toll Free Phone: (800) 867-1693. Local calls: (954) 772-HELP (4357) or (954) 772-0933 You also may text your message to: (954) 805-5821
All calls are kept strictly confidential
Our address is: 2100 E Commercial Blvd, Fort Lauderdale, Florida 33308-3822
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