3004,12A Main HAL 2nd stage , Bangalore 560008, India.
email: kpravin@giasbg01.vsnl.net.in
Voluntary female Sterilization is the most prevalent contraceptive method today, used by over 138 million married women of reproductive age compared to 95 million in 1984 (1). Evidence suggests that demand for sterilization is a function of supply of Surgical Sterilization in India and other developing countries. Over 31% of all married women in the reproductive age groups have opted for sterilization in India in 1990 as against 23% in 1980 (2). Increases in numbers have been as a result of improvement in surgical procedures , effective training program's and improved health care delivery systems. There has also been a concomitant increase in patient awareness regarding the need for sterilization.
In light of this major progress why promote a non-surgical method? We have contrasted the quinacrine method and the surgical method in terms of their relative efficacy, safety, cost and potential contribution to reducing maternal morbidity and mortality and rapid population growth
Based in the current trends in the growth of female sterilization in India it is estimated that there will be an additional 10 million sterilizations by the year 2000, thereby raising the prevalence from 31% to 36% of eligible couples (2). This small increase is due to the fact that half the gains is being offset by the increase in numbers of married women of reproductive age. If we are to achieve an prevalence of 47% as is now seen where sterilization is available without barriers of cost and availability, it is estimated there will be over 40 million additional sterilization's by the year 2000 (2). It is unlikely that surgical sterilization's can meet this demand because of inherent limitations of surgical sterilization's. Even in heydays of camp sterilization's 5000 sterilization's were performed in a period of 3 months by a team from Baroda Medical College (3). If doctors from all medical colleges were to match this feat approximately 0.5 million sterilization's could be performed. This represents around 12 to 15 % of the increase in sterilization's required to achieve the prevalence of 47%. Also this does not take into account the present levels of sterilization's required to maintain the status quo.
Based on the sheer numbers involved it is highly unlikely that a surgical approach to sterilizations will succeed and what is needed is an non-surgical method of female sterilization. A recent review of on going research of non-surgical methods suggests the quinacrine pellet method of non-surgical sterilization is the only one ready for large scale use (4).
This method developed by Zipper et al (5) , involves transcervical application of pellets of quinacrine and an anti-inflammatory ibuprofen in the proliferative phase 6th to 14th of the menstrual cycle using a copper T intrauterine device like inserter. The pellets are cylindrical in shape to accommodate the inner cylinder of the inserter. Seven pellets of 36 mg of quinacrine (252 mg) rapid dissolution time are inserted. The application technique is slightly different from that of an IUCD insertion, in that after the inserter has been introduced into the uterus after evaluation of uterine length, it is withdrawn from the uterus by 0.5 cm and then the plunger is advanced after fixation of the inserter sleeve to expel all the pellets into the uterus . The procedure is performed twice at monthly intervals. Inserter is preloaded with pellets & the entire package comes presterilized by radiation or ethylene oxide.
- Medroxy-progesterone 150 mg IM given on the day of first insertion, or alternatively, Oral Contaceptives are prescribed from the first insertion cycle & continued for three cycles.
- Anti-prostaglandin such as 200mg Ibuprofen orally on the day of the first & second insertions
Quinacrine acts by chelation of the DNA by formation of quinacrine-DNA complexes. This action is belived to result in fibrosis of the endothelial lining of the proximal areas of the fallopian tubes (6) . Endometrium is spared as it has a high levels of zinc which prevents DNA-quinacrine complexes. Anti-prostaglandin adjuvants such as ibuprofen and diclofenac sodium probably act by preventing disposal of quinacrine from the local area by inflammatory reaction (6) .
Medroxy-progesterone 150 mg IM or the Oral Contraceptives (OC's) acts by relaxing the tubal musculature , resulting in increase influx of quinacrine solution into the fallopian tubes. In addition it acts as a temporary contraception, till fallopian tubes are fibrosed.
The quinacrine pellet method requires technical skills similar to that for an IUCD insertion. In large trials conducted world over the procedures have been increasingly carried out by nurses and paramedical personnel quite efficiently (7). Thus the potential access for this method is very large and with a minimal levels of training large number of operators can be recruited.
The quinacrine pellet method originally considered to have a lifetime failure rate of 5-6% , shows remarkable improvement with the increase in number of insertions and additions of antiprostaglandins (8). Most ongoing studies have shown a failure rate from 1- 2% at the end of one year and the largest study in Vietnam have shown a failure rate of 2% and this is without additions of antiprostaglandins (7). Further studies with additions of antiprostaglandins such as ibuprofen, and diclofenac sodium along with Medroxy-progesterone 150mg IM have demonstrated failure rates between 1.4% to nil when followed up for a period of two years (9, 10 ).
Surgical sterilization is highly effective and forms an effective benchmark of comparison. It has a low failure rate of less than 0.5% at the end of one year, however a 10 year follow up shows a failure rate of upto 2.5%.
The efficacy of newer protocols in the short term approaches that of surgical sterilization while on long term is still unknown. This marginal difference in efficacy is totally overshadowed by the excellent record on safety that quinacrine pellet method has over the surgical method.
In over 30,000 cases of quinacrine pellet sterilizations in Vietnam, 10,000 cases in India and 5000 cases in other regions not a single death has been reported (11). Whereas for surgical sterilizations carrying a case fatality rate of 21 per 100,000 in India (12 ,13), we would have expected 10 deaths.
Morbidity is another important aspect of safety. All major reports of the quinacrine pellet method are uniformly reassuring by their absence of any serious life threatening complications. In a large field trial at Vietnam there were common side effects such as lower abdominal pain, headache and mild fever which were easily treated with analgesics. Surgical sterilization carried an total major complication rate varying from 1.7 to 5.7% in various reviews (14, 15).
Long term sequelae of both methods have been a concern, but present evidence suggests that both procedures are free of the problem. There has been a worry that quinacrine pellet method may induce carcinogenesis but recent studies have shown no increased risk either in the form of increased incidence of abnormal pap smears (18) or in the increased risk of cancers (19) in women who underwent quinacrine pellet method of female sterilization.
Since non-surgical method produces proximal tubal occlusion that does not extend beyond the muscularis layer the surgical approch for reversal involves reimplantation of the tube . This approach has a 50% intrauterine pregnancy rate. While reversal of surgical method of sterilisation involves excision of the scar and reanastomosis of the healthy ends and this has a intrauterine pregancy rate of 80%
From all available data at this time it appears that the quinacrine pellet method of female sterilization is far safer than surgical sterilization .
The most potent argument for the Q method is that it is far easier to deliver in rural areas with high maternal mortality rates. It has always been difficult to deliver safe surgical sterilization in rural areas of India where it was required the most. It is in these areas where every sterilization can prevent two births. In these areas the maternal mortality is between 500 to 1000 per 100,000 live births. At a cost of less than Rs 1500, a maternal death can be prevented (a single sterilization by the Q method costs less than Rs 30) (8). It is estimated that to reach a complete coverage of sterilization in this country we will have to complete over 40 million sterilizations by the end of this decade. Only quinacrine pellet method can meet this demand and thus prevent over 80 million births and around 800,000 maternal deaths.
Maternal morbidity which is unfortunately unmeasured , is a factor that has to be accounted in weighing the role of quinacrine method in its role in reducing maternal morbidity.
In India where 38% of births are of the fourth child (16) and above especially in rural India, this method can have a tremendous impact. It is in this group of older high parity women not wanting further children , where this method will make a major contribution. These populations have a poor access to surgical sterilizations and continue to miss the opportunity to contracept leading on to an ever-growing parity status. Q method due its ubiquitous delivery is an ideal candidate for these populations.
In younger women the situation is slightly different. By the age of 29 nearly 80% of the married women would have had their third child (17). So by the time the health provider has got to them the demographic damage is already done. In most cases women would have avoided permanent sterilization after their second child as the risk to benefit analysis done by them does not favor immediate sterilization or there is no easily accessible point of sterilization. By the time the women decide to sterilize they have had another child or maybe more. Q method again due to its easy availability and delivery which may be handled by the local nurse can alleviate this problem.
The greatest advantage of theis method over surgical method is that it has the possibility of raising the contraceptive prevalence with ease of delivery which no surgical method can match while at the same time providing an efficacious contraception. The cost of quinacrine for two insertions is less than Rs 35 ($ One) & when combined with long acting progestins the cost is around Rs 100 ($ Three). There is at this time no other cost effective & safe sterilization method available which can match the quinacrine pellet method.
- Robey, B., Rutstein S.O., Morris L., and Blackburn, R. (1992). The reproductive revolution: new survey findings. Popul. Rep. [M] No.11. (Baltimore , MD: Population Information program).
- Ross J.A., Sterilization: past ,present future. Stud Fam Plann [In Press].
- The John Hopkins Program for International Education in Gynaecology and obstetrics: Dr. Rohit Bhatt of India Relates Experiences. JHPIEGO Newsletter, Vol IV, No. 3, October 1979, p 1.
- Bachicha J.A. Female sterilisation: reveiw and update. Female Patient 1991; 16: 49-56
- Zipper J,Cole LP, Goldsmith A, Wheeler R, Rivera M. Quinacrine hydrochloride pellets: preliminary data on a nonsurgical method of female sterilisation. Int J Gynaecol Obstet 1980;18:275-90.
- Kessel, E., Zipper, J. and Mumford, S.D (Eds.) (1990). The quinacrine pellet method for non-surgical female sterilization: a collection of background materials. (Research Triangle Park, NC: Center for Research on Population and Security).
- Hieu, D.T., Tan,T.T., Tan, D.N., Nguyet, P.T., Than, P. and Vinh, D.O.(1993). 31,781 cases of non-surgical female sterilization with quinacrine pellets in Vietnam. Lancet, 342,213-17.
- Kessel, E., Zipper J., Hieu D.T., Mullick B., and Mumford S.D. (1993). Quinacrine pellet method of non-surgical female sterilization. Proc. of VIII th World congress on human reproduction. Bali, Indonesia, April 1993.
- Mullick, B.C., Kessel,E.,and Mumford, S.D.,(1993). Quinacrine pellets and adjuvant clinical trials for non-surgical female sterilization in West Bengal, India. (In preparation).
- El Kady, A.A., Nagib., H.S.,and Kessel.E. (1993). Efficacy and safety of repeated transcervical quinacrine pellet insertions for female sterilization. Fertil. Steril., 59.301-4.
- Sokal, D.C., Kessel.E., Zipper.J., and King.T.(1994). Quinacrine: Clinical experience. A background paper for the WHO consultation on the development of new technologies for female sterilization. 1994.
- Peterson, H.B., Lubell,L., DeStefano, F., and Ory .H.W. (1983). The safety and efficacy of tubal sterilization: an international overveiw. Int J. gynaecol.Obstet., 139-44.
- Bhatt RV. Camp laproscopic sterilization deaths in Gujrat state, India 1978-80. Asia Oceania J Obstet Gynaecol 1991;17:297-301
- Bhiwandiwala, P.P., Mumford, S.D. and Feldblum, P.J. (1982). A comparison of diferrent laproscopic sterilization occlusion techniques in 24,439 procedures. Am. J. obstet. gynecol,14,319-31.
- Layde, P.M., Peterson, H.B., Dicker, R.C., DeStefano, F., Rubin.G.l., and Ory, H.W. (1983). Risk factors for complications of interval tubal sterilization by laparotomy. Obstet. Gynaecol. 62,180-4.
- Government of India. (1991). Child survival and safe motherhood project- India, p.2. ( New Delhi: Ministry of Health).
- Government of Karnataka. (1994). Family planning statistics for the state of Karnataka -1993. (Bangalore: Department of health and family welfare)
- Dabancens, A., Pruyas, M., Rivera, M. and Zipper, J. (1990). Prevalence and standardized incidence ratesof preclinical cervical pathology obtained from 1061 women sterilized with intrauterine pellets of quinacrine. Paper presented at the Symposium on the quinacrine pellet method of non-surgical female sterilization. Fertil. Steril. 64: 444-446
- Sokal DC, Zipper J, Guyman-Serani R, Aldrich TE. (1995). Cancer Risk among women sterilized with transcervical Quinacrine hydrochloride pellets, 1977 to 1991, Fertil. Steril. 64: 325-334.