THE QUINACRINE METHOD PROCEDURE MANUAL
Chapter 1 Introduction
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 Learning ObjectivesAt the end of this lesson, you will be able to:
Female SterilizationMillions of women throughout the industrialized and developing world have chosen sterilization; it is one of the most preferred methods of family planning for women who have decided not to have any more children. Although women remain fertile into their late 40s or early 50s, many have already had all the children they want during their 20s or 30s.Surgical sterilization has been practiced for 170 years. Thirty years ago, scientists began experimenting with nonsurgical sterilization. Quinacrine sterilization, the focus of this manual, has thus far produced the best and safest results among nonsurgical methods. How Does Female Sterilization Work?Every month, one of a woman's ovaries releases an egg. This egg moves down one of the fallopian tubes to the uterus. If sperm is present in the fallopian tubes to fertilize the egg, conception may occur. Female sterilization is done by permanently closing the fallopian tubes to prevent the union of the egg and sperm, and consequently prevent conception.In surgical sterilization, the fallopian tubes are closed primarily through one of several methods; fastening a little clamp or elastic band onto each fallopian tube to close it off, by cutting each tube and then tying the open ends, by tying off a loop of each tube, or cauterizing the tubes. |  | |  |
In nonsurgical sterilization, the drug Quinacrine is inserted into the uterus. This drug causes inflammation of the fallopian tubes and the formation of a scar. The scar tissue is primarily in the intramural segment of the tubes and permanently blocks the fallopian tubes. Quinacrine Female Voluntary Nonsurgical SterilizationQuinacrine, also known as Atabrine or mepacrine, is a drug that was originally introduced in 1931 to prevent and cure malaria, and has subsequently been used by millions of people. Today it continues to be prescribed for giardiasis.In the 1970s, scientists began to experiment with quinacrine, and other drugs with scarring properties, as an alternative to surgical sterilization. Quinacrine pellets produced the best and safest results. Since then, over 125,000 women in over thirty countries have used quinacrine as a method of nonsurgical sterilization. In the 1970s and 1980s, clinical trials with quinacrine pellets were conducted in several countries. Those with the most cases were Chile (Zipper et al., 1980), Egypt (El Kady et al., 1993), India (Bhatt and Waszak, 1985), Pakistan (Bashir, 1993), Vietnam (Hieu et al., 1993), and Indonesia (Agoestina and Kusuma, 1992 and Suhadi et al., 1998). QS is a simple procedure, very similar to the insertion of an IUD, which requires no hospitalization, has a short recovery period and has a much lower risk of infection than that associated with surgical sterilization. Some countries have postponed including QS in their family planning programs. In other countries, including the United States, official trials are in progress and some nongovernmental organizations (NGOs) offer QS in their family planning programs. How Does Quinacrine Sterilization (QS) Work? | ||
1. Two doses, each consisting of 252 mg of quinacrine hydrochloride in the form of pellets, are inserted one month apart, into the uterine cavity. The pellets are inserted using a modified intrauterine device (IUD) inserter during the proliferative phase of the menstrual cycle (days 6 to 12 after the onset of menstruation). Correct placement of the pellets at the top of the uterus (fundus) is one of the most important steps of the procedure. | |  |
2. The quinacrine pellets dissolve within about 30 minutes. The liquid quinacrine flows throughout the fundal portion of the uterine cavity and into the fallopian tubes. Excess quinacrine is either discharged into the vagina or absorbed through the endometrium. (Note: Damage to the endometrium recovers within a few cycles, and normal menstrual periods then resume.) | |  |
3. Over a period of several hours to several days, this produces partial necrosis of the endometrial lining of the uterus and the mucosal lining in the intramural segment of the fallopian tubes. Although the endometrium regenerates itself over a period of one or more menstrual cycles, inflammation of the tubes progresses into the inner muscular layer, preventing regeneration of tubal mucosa. | |  |
4. Over the next 6-12 weeks, a small fibrous mass forms, joining the walls of the intramural tube and occluding or filling the lumen. The inflammation of the fallopian tubes subsides and a plug of scar tissue remains. Because scarring requires 6-12 weeks, women are counseled to use a backup method of contraception for 12 weeks. | |  |
EfficacyStudies conducted 10-20 years ago reported higher failure rates than we see today. As a result of the work of Hieu et al. (1993), the cause of many of the failures was discovered and the importance of placing all of the pellets at the fundus (near the tubal ostia) established. Since the adoption of a new insertion technique in 1993, the failure rates reported have been 2 out of 100 women or less after 2 years. Because of improvements in the technique, it is estimated that after 10 years, fewer than 5 of 100 women will become pregnant (Soroodi, 1996; Bairagi, et al., 1995; Sarin, 1999; Ferreira et al., 2000).SafetyEven though QS has been widely used, questions about its safety and efficacy still remain. Safety can be thought of in terms of short-term or long-term complications of a contraceptive method. It is well documented that, in terms of short-term effects, QS is very safe and definitely safer than surgical sterilization. Approximately 125,000 quinacrine sterilizations have been performed without a fatality, whereas case-fatality for surgical sterilizations ranges from 2 per 100,000 in industrialized countries to 20 per 100,000 in some developing countries. Major complications are also lower for QS, reported at a rate of 0.03% compared to 1.7% for laparoscopic sterilization. This difference is exaggerated for some patients, such as diabetics, those needing a general anesthetic, those with a history of previous abdominal or pelvic surgery, pelvic inflammatory disease (PID), respiratory disease or obesity.In terms of long-term complications, being a relatively new method, these are not definitely known. Cancer is one concern, as it may take 10-20 years to appear. Oral administration of quinacrine at higher doses and over longer periods than those needed for QS has not been associated with reports of increased cancer risk. A study in Chile by Family Health International of 1492 women who had QS up to 19 years earlier found no increased risk of cancer after 13,444 person-years of follow-up (Sokal et al. 2000). Some laboratory tests, such as the Ames test used to predict carcinogenicity, are positive for quinacrine. In cancer producing drugs about 60% of Ames tests are positive. However, a very large number of substances that are positive for the Ames test obviously do not produce cancer, including coffee and grilled hamburger meat. When human evidence is available, it is more valuable than a screening toxicology test. There is only one rational criterion to judge the use of a new treatment. This is the risk-benefit analysis, which will vary by place. For example, the benefits of a new contraceptive that can raise contraceptive prevalence, and thereby lower maternal mortality, will be far greater in an area of high maternal mortality and low contraceptive prevalence. For example, rural areas of developing countries have far higher maternal mortality and lower contraceptive prevalence than industrialized countries. The risk-benefit analysis will differ for developed countries. Experienced toxicologists believe that the lack of reports of carcinogenicity of quinacrine in humans to date means that it either does not cause cancer or that the risk of it causing cancer is low. The savings in maternal mortality by increased contraceptive prevalence in developing countries is high. Sterilization prevents, on average, two pregnancies. Thereby, in an area with maternal mortality of 5 per 1,000 live births, each 1,000 additional quinacrine sterilizations would avoid 10 maternal deaths. There is no more cost effective way than QS to lower maternal mortality in such areas. Possible ComplicationsResearch has been done around the world to determine the safety of Quinacrine sterilization (QS). What is known is that QS is safer than surgical sterilization, especially in parts of the world where equipment is in short supply. So far, there have been no deaths and few serious complications from quinacrine sterilization. In The Lancet paper on the clinical experience of over 30,000 women in Vietnam, eight cases of major complications were reported (Hieu et al., 1993). This is a rate of 0.03% or 1 in 3,000. The risks associated with QS are much less than those associated with carrying a pregnancy to term.Possible complications of QS may include: Failure of the procedure - If the pellets are not correctly placed or if only one insertion is done, there is a greater chance that the procedure will not successfully result in permanent sterilization. This is called a "method failure." Among method failures, QS unfortunately does not always prevent ectopic pregnancy. The risk of ectopic pregnancy after QS is less than among noncontraceptors and about equal to that of IUD users. The most effective means of lessening the risk of serious illness or death due to ectopic pregnancy is to lower method failures and to counsel all clients who suspect pregnancy to contact or see a provider immediately. Infection of the pelvic cavity - This can be prevented by use of aseptic techniques during the procedure and proper care afterwards. This will be explained in detail in a later chapter. Perforation - or puncturing the uterus. This can be the result of forceful insertion of either the sounding device (which is used to measure the length of the uterus) or the quinacrine inserter. Regret - or a change of mind about the client's decision to terminate her fertility. Clients should be completely informed and counseled prior to the procedure. See the following chapter for more information on counseling for sterilization. Hematometra - or accumulation of menstrual blood in the womb. This may occur in about 1 in 5,000 cases when quinacrine causes closure of the internal cervical os. Uterine synechia - or adhesions between the anterior and posterior uterine walls. Although rare, these have been reported following multiple insertions. Refer to Chapter 4 of this manual for information on management of these complications and the following possible side effects. Possible Side EffectsNearly half of all women complain of one of the following transient side effects. These effects usually last from a few hours to a few days. It is extremely important to counsel women about these possible side effects before they decide to have the procedure, so that they can make a fully informed choice. It has been shown that those women who were effectively counseled for their first insertion were much more likely to return for their second insertion. Those who have two insertions are half as likely to experience a method failure as those who have only one insertion.Possible side effects are:
These will be addressed in greater detail in Chapter 4. Timing of InsertionQuinacrine sterilization must be performed during the proliferative phase of the menstrual cycle (days 6 to 12 after the onset of menses). This was initially recommended to avoid inserting quinacrine in a woman who was unaware that she was pregnant. However, further research suggests that blood in the uterus interferes in some way with the action of the quinacrine. On days 13- 21, as the endometrium builds up to prepare for a fertilized egg, it is more likely to tear and bleed if scratched by the cannula/sound or inserter. Thus, there are several reasons why it is very important to perform this procedure within days 6-12 of the onset of a woman’s menstrual cycle.If more than 1 ml of blood was discharged through the cervix during or after the insertion, then a third insertion should be scheduled. Postpartum - It is recommended to wait six weeks after delivery, in order for the uterine cavity to return to normal size. Postabortion - After an induced or spontaneous abortion, if the client was in her first trimester, QS can be performed after a regular menstrual period. This usually occurs after one month. If the client was in her second or third trimester, it is recommended that, as in the case of a postpartum QS, the woman wait six weeks after the abortion, in order for her uterine cavity to return to normal size. Advantages of Quinacrine Sterilization (QS)
Disadvantages of Quinacrine Sterilization (QS)
Case Study IA provider has just explained to the client the advantages and disadvantages of QS, the fact that it is a permanent method of contraception, and the possible side effects and complications. The client asks the provider to explain how QS works and when she should come in for her QS. The provider says the following:"Once you decide to have a QS, you should plan to visit the clinic at the end of your cycle, just after you finish menstruating, so we can be certain you are not pregnant. I will have you lie down and then will insert an anti-malarial, helvetica drug called quinacrine inside you. This drug will fill up your womb and will take up all the space so that a baby cannot grow inside." Has the provider explained the procedure accurately? If not, what did the provider say that was incorrect? Correct the explanation. Case Study IIClient X arrives at your clinic after a 4-hour journey from a rural province. She says she has heard about the QS method from a neighbor and would like to have a QS today. You explain the method to her, including its advantages and disadvantages, the appropriate time to have a QS and other relevant information.During the bimanual pelvic exam you discover the client has a heavy menstrual flow. The client claims it is the last day of her period, and that she must have a QS today; and that she is unable to make the journey again for quite some time. Identify the problem: What action would you take? Check your answers against those provided on page 49. Return to the chapter text for any information you did not understand. | ||