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International Journal of Gynecology and ObstetricsSupplement AbstractsQuinacrine sterilization: a retrospective J. Zipper,1 E. Kessel2 1Department of Obstetrics and Gynecology, Sótero del Rio Hospital, University Of Chile, Santiago Chile 2Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon, USA Keywords: quinacrine sterilization, female sterilization, contraception Synopsis: A historical account of the development of this non-surgical female sterilization method Corresponding author: Dr. Jaime Zipper Abstract (Go to full pdf article) Objective: To trace development of quinacrine sterilization (QS). Methods: Review of published reports. Results: The high prevalence of septic abortion among high parity women in Santiago, Chile, motivated Zipper to find a safe, inexpensive method of non-surgical female sterilization. Various cytotoxic drugs were tried in rats. Because quinacrine was already accepted for intrapleural injection it was chosen for the first clinical trial. A slurry consisting of quinacrine and xylocaine was instilled into the uterine cavity with a transcervical syringe. Reasonable efficacy was noted and a limited scar of the intramural tube demonstrated. However, a side effect of cortical excitation and reports of 3 deaths ended this approach. Zipper and Wheeler hypothesized that the difficulty was due to rapid absorption of quinacrine under pressure and designed a pellet form that dissolves slowly and could be delivered transcervically using a modified IUD inserter. A standard protocol of 252 mg in seven 36 mg pellets placed at the uterine fundus on two occasions a month apart has now been widely used with considerable evidence for safety and efficacy. Indeed, protection is greater than 98% at 2 years of use. Conclusion: QS is ready for widespread use, especially where surgical sterilization is not safely available or when women are poor candidates for surgery or have such a fear of surgery that they will not seek surgical sterilization.
Quinacrine Sterilization (QS): The Ethical Issues S. Bhattacharyya School of Social Science, Philosophy and Religion Synopsis: This paper examines various complex ethical issues associated with quinacrine female sterilization (QS) and presents a course of action that addresses many concerns from both sides. Keywords: quinacrine sterilization, arguments pro and con, beneficence, respect for life, ethics Corresponding author: Swasti Bhattacharyya, Assistant Professor Abstract (Go to full pdf article) QS has generated debates that are ultimately grounded in various principles, norms, and values. Through a careful analysis of opposing arguments, this paper focuses on two ethical principles claimed by both sides, namely: respect for life and beneficence. Though issues surrounding QS are complex, from the common ground of these two principles, this paper proposes a course of action that addresses many of the concerns from both points of view.
25 years of quinacrine sterilization experience in Chile: review of 2,592 cases. J. Zipper1 , V. Trujillo2 1University of Chile, Sótero Del Río Hospital, Santiago, Chile 2San José Hospital, Santiago, Chile Synopsis: An assessment of research on quinacrine sterilization (QS) from its inception in Chile through a quarter century of safety and efficacy Keywords: quinacrine sterilization, non-surgical female sterilization Corresponding author: Dr. Valentin Trujillo Abstract (Go to full pdf article) Objectives: To assess short-term side effects, long-term risks and efficacy of quinacrine sterilization (QS) in Chile. Methods: Review experience of 2,592 cases sterilized with 2 or 3 transcervical insertions of 252 mg quinacrine as pellets since 1977; review the Chilean pre-clinical experience and epidemiological studies on cervical, endometrial and other cancers. Results: Among 2,592 women who underwent QS, the total number of pregnancies was 119 (4.6%); 59 (49.5%) were carried to term with no birth defects related to QS. Nine cases were ectopic pregnancies. The ectopic pregnancy risk per 1,000 woman-years was 0.41, similar to that for surgical sterilization. The cumulative life-table pregnancy rates per 100 women at 10 years varied from 5.2 to 6.9. Mild and transient side effects were reported in 13.5% of quinacrine intrauterine insertions and pelvic inflammatory disease was diagnosed in 4 cases (0.15%). Long-term follow-up of quinacrine-sterilized patients shows no increased risk of cervical, endometrial or other cancer. Conclusions: QS efficacy at 10 years is comparable to widely accepted tubal clip and single point bipolar electrocoagulation laparoscopic procedures. QS has a low risk of serious, immediate side effects. No long-term risks have been identified after 25 years of use.
Quinacrine nonsurgical female sterilization in Baroda, India: 23 years of follow-up of 84 women R.V. Bhatt Department of Obstetrics and Gynecology Key words: quinacrine sterilization, nonsurgical sterilization, female sterilization Synopsis: After 23 years following quinacrine sterilization, no long term side effects were detectable in this series of 84 women. The failure rate was 3.7 per 100 women. Corresponding author: Dr. Rohit V. Bhatt, Chief Abstract (Go to full pdf article) Objectives: Evaluate the long-term effectiveness and safety of transcervical insertion of quinacrine hydrochloride pellets for nonsurgical female sterilization (QS). Methods: During the period June 1979 through January 1980, 84 women were admitted to a study at the Baroda Medical College and Hospital, Baroda, India. Our protocol called for three transcervical insertions of 252 mg of quinacrine hydrochloride to be deposited in the uterus of each patient. Follow-up was scheduled at 6, 12 and 48 months after the last administration. Results: These women were 25 to 39 years of age at the time of the QS procedure and now, 23 years later, have completed their reproductive years. There were 4 pregnancies subsequent to the completion of QS, all prior to their 4-year follow-up. Thus, the life-time failure rate for these women was 3.7%. Complaints were minor, especially when compared to surgical sterilization. There were no long-term effects suspected of being attributable to QS. Conclusions: QS appears to be a reasonably effective method that is much safer than surgical sterilization.
D.T. Hieu,1&2 T.T. Luong2 1Director (retired) 2Department of Maternal and Child Health/ Family Planning Key words: quinacrine sterilization, ectopic pregnancy, tubal ligation, female sterilization, IUD Synopsis: Every ectopic pregnancy during 1994-1996 in four Vietnam provinces is identified. Ectopic rates for QS, surgical sterilization, temporary methods and no contraceptive method are determined. Corresponding author: Dr. Do Trong Hieu Abstract (Go to full pdf article) Objective: To determine the rates of ectopic pregnancy with the use of quinacrine sterilization (QS) compared to other methods and no method (non-users). Methods: Four provinces were selected for their above average numbers of women who had undergone QS: Nam Dinh, Nam Ha, Hai Duong and Hung Yen. Case histories related to surgical treatment of all ectopic pregnancies in these 4 provinces from 1994 through 1996 were collected from all hospitals by researchers from the Ministry of Health in June 1997. Using a questionnaire designed for this study, 120 physicians interviewed every woman in her home who had had an ectopic pregnancy during this period. If deceased, a family member was consulted. All interviews were completed in September 1998. The numbers of users of each method and nonusers were calculated from service statistics and demographic data. Results: Based on 2,551,355 woman-years of exposure, the rate of ectopic pregnancy among users per 1000 woman-years was calculated to be: 0.26 with QS; 0.42 with surgical sterilization (TL) and IUD; 0.45 with the Pill; 0.50 with condoms; 0.78 relying on withdrawal; and 1.18 among non-users. Conclusion: Ectopic pregnancy rates for QS, TL, IUD and the Pill were similar and much lower than the rate for non-users of contraception.
An FDA approved clinical trial of quinacrine sterilization(QS) J. Lippes, M. Brar School of Medicine Key Words: Quinacrine Sterilization (QS), FDA, oviducts, ultrasound Synopsis: A clinical trial of QS was carried out on ten patients with approval from the United States Food and Drug Administration. Oviductal scars were identified with ultrasound in every patient. Corresponding author: Jack Lippes MD Abstract (Go to full pdf article) Objective: To review the significance of a United States Food and Drug Administration (FDA) approved Phase I clinical trial of a new use for an old drug, quinacrine. To discover whether ultrasound may have utility in quinacrine sterilization (QS). Method: This clinical trial began on 16 September 2000 at the Women’s and Children’s Hospital of Buffalo (WCHOB) in Buffalo, New York. Ten patients volunteered to have QS. These subjects were carefully followed with regularly scheduled examinations, including extensive laboratory blood tests. In addition, each patient had a trans-abdominal ultrasound examination six weeks or later past the date of the second insertion of quinacrine. The trial was completed on 30 April 2003. Results: Laboratory results fell within normal limits, thus providing additional evidence to affirm the lack of toxic effects of QS. With ultrasound, we were able to see scars in both oviducts on all of our patients. One patient with a small scar as seen on ultrasound became pregnant. Conclusion: QS was found to be safe and effective. Ultrasound holds the promise of reducing the failure rate.
W. Lu,1 J. Zhu,2 C. Zhong,2 Y. Zhao2 1Center for Research on Population, Guizhou University, Guiyang 550025, China 2Guizhou Provincial Research Institute for Family Planning, Guiyang 550025, China Synopsis: Both methods were found to be safe. Among women who received 2 insertions of quinacrine, the cumulative life-table failure rate per 100 women at 24 months was 1.2 (SE=0.69) compared to 0.7 (SE= 0.47) among those surgically sterilized. Key words: quinacrine sterilization, nonsurgical sterilization, tubal ligation Corresponding author: Dr. Lu Weiqun Abstract (Go to full pdf article) Objectives: Compare the safety and efficacy of quinacrine sterilization (QS) and surgical sterilization, also known as (TL). Methods: 300 women accepted QS in Guiyang, China during the period from July 1995-September 1997. Each patient was scheduled for follow-up at 3, 6, 12 and 24 months. In March 1998, a comparison group of 300 women electing TL during the same time period was systematically chosen. Researchers visited the village of every woman and conducted a structured interview. Each candidate was given a general health and pelvic exam at a clinic in her village. All interviews and exams were completed in August 1998. Results: Of the 289 QS patients interviewed (a follow-up rate of 96.3%), 265 had had 2 insertions. There were 3 pregnancy failures for a cumulative life table failure rate of 1.2 per 100 women at 24 months. The 299 TL patients (a follow-up rate of 99.7%) had a similar rate of 0.7. There were no life threatening side effects or deaths in either group. QS was less disruptive, more easily tolerated, required fewer resources and was viewed more favorably than TL by women and their spouses Conclusions: Both methods were found safe and very effective. However, QS was considered to be more acceptable than TL.
C.R.C. Ferreira, D.R.B. Magalhães, D.C. Ferreira, M.Z. Hanan, A.F. Camargos Department of Obstetrics and Gynecology Keywords: quinacrine; nonsurgical female sterilization; endometrial assessment after QS Synopsis: Transvaginal ultrasound may be helpful for preventing clinical failures and to identify blockage of the oviducts after QS. Corresponding author: Dr. Cláudia R. C. Ferreira – Fax 55 (31) 3225-0298 Abstract (Go to full pdf article) Objective: Investigate effectiveness, safety and endometrial pattern after QS. Method: This study began in March 1999 and ended March 18,2003; 128 women received transcervical insertions of quinacrine. Follow-up visits with ultrasound were scheduled at 1, 3, 6, 12-month intervals. Results: Two pregnancies occurred, one at 25 months, the other at 37. Adverse events (AE) were: yellow vaginal discharge, headache, mild abdominal pain, vaginal pruritus, nausea and transient decrease in endometrial thickness. One patient had allergic reaction. A third insertion was done in case of vaginal bleeding (16.4%). One year after QS 10% still had amenorrhea, which may be the result of the fact that 73% of our patients had received DMPH. Once inside the uterus, the dissolved quinacrine could be seen within seconds, via ultrasound as a "Lake of Quinacrine" which stays for up to two hours. Frequently, a transverse vaginal ultrasonographic view of the uterine cavity showed plug-like echogenic points at the cornua.
A. Bashir, M. Bashir, S. Afzal Mother & Child Welfare Association Key words: quinacrine sterilization, female sterilization, sterilization training Synopsis: Outcomes of quinacrine sterilization markedly improved after retraining of clinicians to use a newly accepted transcervical insertion technique of 252 mg of quinacrine with efficacy of 1.1% (SE 0.4) at 5 years of use. Corresponding author: A. Bashir, President Abstract (Go to full pdf article) Objective: To determine the impact of retrained clinicians on the efficacy of transcervical quinacrine sterilization. Method: Retraining of clinicians in the accepted insertion technique was conducted in 1996. From 1 January 1997 through 2001, they performed 1089 quinacrine sterilizations in 11 MCH clinics of the Mother & Child Welfare Association at Faisalabad, Pakistan. Of these, 885 women had a recorded follow-up visit (81.4%) by 31 December 2001. Result: Reported pregnancy failures declined after retraining from 5.4% (SE 2.3) for one year of use to 1.1% (SE 0.4) for 5 years of use. The rates at 4 years of use showed the expected increase in failures for women 30 years old or younger of 1.5% (SE 0.7) compared to 0.9% (SE 0.4) for those over 30; a lower rate of 0.8% (SE 0.4) for breastfeeding subjects and 2.2% (SE 1.1) for mothers not breastfeeding; but rates were similar for uterine length and post insertion traumatic bleeding. Conclusion: Quinacrine sterilization appears safe with acceptable efficacy.
Quinacrine sterilization (QS) among high-risk women: a study of 134 cases A.R. Sarin,1 R.K. Sarin2 1Department of Obstetrics & Gynecology 2Aastha Medical Center Keywords: quinacrine sterilization, nonsurgical sterilization, high-risk women Synopsis: 134 women at high risk for surgery received quinacrine sterilization. After an average of 7.2 years of follow-up, there have been no pregnancies or serious complications. Corresponding author: Professor Ashi R. Sarin Abstract (Go to full pdf article) Objective: To determine if quinacrine sterilization (QS) is safe and effective in women at high risk for surgery. Methods: A trial was initiated at the Government Medical College in Patiala, India, in December 1993. Patient intake was terminated in July 1999 and the cut-off date for this analysis was March 31, 2003. Using a modified IUD inserter, seven 252 mg quinacrine pellets with 50 mg of diclofenac were transcervically inserted into the uterus. DMPA 150 mg was administered IM at the time of the first insertion as a back-up contraceptive. This same combination was inserted a month later. A total of 134 women underwent QS. Of these, 92 were considered to be at high risk for surgery, 27 were afraid of surgery or voluntarily opted for QS and 15 had had failed surgical sterilization or surgery was found not to be technically feasible. Follow-up was scheduled for 1, 3, 6 and 12 months, and then annually after the second insertion or whenever side effects or complications were experienced. Results: Mean follow-up was 7.2 years. No pregnancies or serious complications were experienced. Conclusion: QS is a safe and effective option for women at high risk of surgical complications.
D.T. Hieu,1 T.T. Luong,2 P.T. Anh,2 D.H. Ngoc,2 L.Q. Duong2 1Director (retired) 1,2Department of Maternal and Child Health/ Family Planning Key words: surgical sterilization, quinacrine sterilization, female sterilization, vasectomy Synopsis: This is a retrospective study of 15,190 users of tubectomy, quinacrine sterilization and vasectomy who were sterilized between 1989 and 1998 in 9 districts in 5 provinces of Vietnam. All are interviewed. Corresponding author: Dr. Do Trong Hieu Abstract (Go to full pdf article) Objectives: To compare the safety, efficacy and acceptability of quinacrine sterilization (QS), tubectomy and vasectomy in Vietnam. Methods: This study was initiated in January 1998 and completed in February 2000. A sample of 9 districts in 5 provinces, where the prevalence of QS was known to be high, was selected. Every person sterilized in these 9 districts between January 1, 1988 and March 31, 1998 was identified and systematically interviewed by family planning clinicians who had received special training for this project. Results: A total of 15,982 sterilization users were identified and 15,190 were interviewed and examined, including a gynecologic exam, if needed: a follow-up rate of 95%. Of those interviewed, 9,753 used tubectomy, 3,734 used QS and 1,703 used vasectomy. All three methods were found to be safe, although morbidity associated with tubectomy was more serious than with QS or vasectomy. No deaths were reported. After more than 5 years of follow-up, tubectomy had the lowest failure rate: 1.0%, followed by 4.1% with vasectomy. A pregnancy rate of 13.2% was reported with quinacrine, although only a small fraction of these failures were confirmed. A strong preference for QS was found. Conclusion: QS has an important role to play in sterilization services in Vietnam.
A. Roy Family Practitioner Key words: quinacrine sterilization, non-surgical female sterilization, female sterilization. Sterilization Synopsis: Five different trials of QS were tried sequentially. The currently recommended standard protocol is safe and shows great promise with a failure rate of 0.8% at 3.5 years. Corresponding author: A. Roy Abstract (Go to full pdf article) Objectives: Evaluate the safety and effectiveness of quinacrine for non-surgical female sterilization in five different protocols. Methods: The 5 trials were conducted sequentially. The first and largest, with 985 cases, tested the use of a curved inserter to place a 50 mg dose of quinacrine near each tubal ostia. The next 3 trials were carried out to determine the effect of adjunct procedures on the efficacy of the standard recommended protocol. The three adjuncts were 75 mg of intrauterine diclofenac, 10 mg medroxyprogesterone IM and either 10 mg of atropine IM or 20 mg of hyoscine butylbromide IM. The final trial focused on the currently recommended protocol. Results: The 100 mg dose placed at the tubal ostia with the curved inserter resulted in a failure rate of 9.0% at 20 years. Diclofenac or medroxyprogesterone did not improve efficacy over quinacrine alone. Atropine or hyoscine butylbromide substantially diminished the effectiveness of the quinacrine. The failure rate with the standard protocol in our series of 122 cases was 0.8% at 3.5 years. Side effects were minor. There were no deaths nor serious complications with any of these protocols. Discussion: All 5 protocols appeared to be safe and the standard one was the most effective.
Quinacrine Sterilization (QS) in Iran and the use of the HSG as a measure of success S. Soroodi-Moghaddam Private Family Planning Practice Key words: quinacrine sterilization, nonsurgical female sterilization, hysterosalpingogram Synopsis: Twelve years of experience with quinacrine sterilization in Tehran has found this method to be safe, effective and acceptable. The use of HSG to determine success of quinacrine sterilization, even under low pressure, results in a higher pregnancy rate. Corresponding author: Dr. Sheitaneh Soroodi-Moghaddam Abstract (Go to full pdf article) Objectives: To establish the safety, effectiveness and acceptability of quinacrine sterilization (QS) in Iran. To determine whether the hysterosalpingogram (HSG) performed under low pressure can be used to demonstrate success of the QS procedure rather than waiting for a pregnancy to occur in order to demonstrate failure. Methods: This study was initiated in September 1990 in a private family planning clinic in Tehran, Iran. Patient intake for this analysis was completed 31 December 1998 and the cut-off date for follow-up data to be included in this analysis was 30 July 2002. During this period, 268 women received QS. From inception until April 1994, 160 women entered the study. The first 62 women received 3 insertions and the remainder received 2. Short-term side effects were closely followed in these 160 women. From 18 February 1994 until the patient intake cut-off date, 131 women entered the study and 46 of them received an HSG. Results: With 4 to 12 years of follow-up there have been 7 pregnancies for a gross pregnancy rate of 2.6%. However, the use of the HSG tripled the risk of pregnancy for women who underwent the procedure. Furthermore, HSG, even when performed under minimal pressure, indicated failure of the QS procedure about 6% of the time when in fact both tubes would have closed had there been no intervention. Side effects were minor when compared to the complications of surgical sterilization. Conclusions: QS was found to be safe, effective and preferred over surgical sterilization by Iranian women. HSG understated the number of patients with bilateral tubal closure, or with tubes that would have closed given a little more time.
S.K. Pal Family Practioner Key words: quinacrine sterilization, sterilization, female sterilization, non-surgical female sterilization Synopsis: In a series of 1479 women using an age dependent dose, no failures (pregnancies) have been reported after up to 8 years of follow-up. Two other protocols produced unacceptably high failure rates. Corresponding author: Dr. S. K. Pal Abstract (Go to full pdf article) Objectives: Determine the efficacy of two different dosage regimens of quinacrine placed at each cornual angle, employing a curved inserter, and for fundal placement of doses from 252 mg to 360 mg of quinacrine, depending on the age of the woman. Methods: 1. The first trial involved 3 double insertions, a month apart, of 50 mg of quinacrine at each cornual angle. This trial was initiated on 14 August 1979 and completed on 26 June 1984 with 418 subjects admitted. 2. The second was a single double insertion of 100 mg at each cornual angle. This trial, initiated on 30 November 1984, was completed on 11 June 1985 with 100 subjects admitted. 3. The third trial began 2 January 1995, was completed 26 January 1998 and included 1479 subjects. There were 2 insertions, a month apart, with fundal placement of all pellets. The dose depended on the woman’s age and ranged from 252 mg in the oldest to 360 mg in the youngest. The cut-off date for this trial was 23 January 2003. Results: Only relatively minor side effects or complications were seen. None required hospitalization. Failure rates with multiple low dose or single dose cornual placement of pellets were unacceptably high. When higher doses of fundal placement of quinacrine were used at two visits, one month apart, no failures occurred. Conclusions: The third protocol shows great promise.
S. El Sahwi, M. Kamel, M. El Faham, I. El Makhzangy Department of Obstetrics & Gynecology Keywords: Quinacrine non-surgical sterilization, hysteroscopy, hysterosalpingography Synopsis: Study of QS occlusion by HSG and hysteroscopy produced identical results. Two applications of quinacrine were 100% effective with minimal side effects. Corresponding author: Dr. Samir El Sahwi Abstract (Go to full pdf article) Objectives: Document the effects on the tube and uterus of one, two and three doses of 252 mg of quinacrine. Method: The study included 180 fertile women seeking permanent contraception at the Shatby Family Planning Clinic in Alexandria, Egypt, in 1988. All cases received three applications of seven 36 mg quinacrine hydrochloride pellets during the proliferative phase of three consecutive menstrual cycles. The patients were randomly divided into groups A, B and C. Hysterosalpingography (HSG) was performed on the 6th day of menstruation and hysteroscopy on the 10th day of the same cycle after the first application in group A, the second, in group B and the third, in group C. The study was concluded in 1999. Results: HSG showed 52 cases of bilateral obstruction, four of bilateral patency, and four of unilateral patency in group A. All in groups B and C elicited bilateral tubal obstruction. Cornual obstruction was seen in 33%, 65% and 85% in group A, B and C, respectively. Intramural obstruction was found in 50%, 33% and 10% in the three groups. Isthmic tubal obstruction was detected in 8%, 2.5% and 5% in groups A, B and C, respectively. Four types of ostial appearances could be recognized hysteroscopically. Type 0 (patent tubes), Type I (distal tubal blockage), Type II (intramural obstruction) and Type III (cornual obstruction). In group A, Type 0 was evident in 10%, Type I in 8%, Type II in 50% and Type III in 33% of cases. The respective figures in group B were 0%, 2.5%, 33% and 65%, while in group C, they were 0%, 5%, 10% and 85%. Hysteroscopy showed no abnormal endometrial findings in group A, but 35% and 85% of cases in group B and C showed some changes. Conclusions: Two applications of quinacrine were 100% effective. The side effects of quinacrine pellet applications were minimal and well tolerated by all the users. The possibility of reversal of the procedure is outlined.
A. Giugni Chalbaud, G. Plaza Mora Concepción Palacios Maternity Hospital Keywords: quinacrine, transcervical intrauterine insertion, sterilization, hysterosalpingography Synopsis: After 30 patients underwent a single insertion of 324 mg of quinacrine in Caracas, more than 86% of them had bilateral tubal occlusion using HSG as an endpoint. Corresponding author: Dr. Aldo Giugni Abstract (Go to full pdf article) Objective: To evaluate the intrauterine insertion of quinacrine as an alternative nonsurgical female sterilization method by confirming bilateral occlusion of the fallopian tubes using HSG in a group of women who desire permanent sterilization. Methods: After doing hysterosalpingography to confirm patency of both fallopian tubes, 324 mg of quinacrine were introduced with a modified IUD inserter in 30 patients who came to Concepción Palacios Maternity Hospital seeking permanent sterilization, between June 2000 and September 2001. Follow-up with HSG was done 3 months later to verify occlusion of the fallopian tubes. Results: 26 of 30 patients (86%) had bilateral tubal occlusion as determined by HSG. There were minor side effects such as: pain (66.7%), yellow discharge (100%) and menstrual abnormalities (13.3%). One woman became pregnant after HSG showed bilateral occlusion. HSG may interfere with the action of the quinacrine. Conclusion: QS is a simple and safe alternative to surgical sterilization with few side effects.
Quinacrine sterilization in Libya: 200 cases M.S. El Mahaishi, A.M. Azzidani Department of Gynecology & Obstetrics Keywords: quinacrine sterilization, female sterilization, nonsurgical female sterilization Synopsis: A study of quinacrine nonsurgical female sterilization in 200 women in Libya found the method to be safe, effective and acceptable. Corresponding author: Dr. M. El Mahaishi Abstract (Go to full pdf article) Objective: Document the safety, effectiveness and acceptability of quinacrine sterilization (QS) as an alternative to surgical sterilization in Libyan women. Methods: This study was initiated 1 October 1998 at the Misurata Central Hospital and Lamis Clinic. Patient intake was completed 30 September 2002. The cut-off date for this analysis was 31 December 2002. A total of 200 women were given 2 doses, each consisting of 252 mg of quinacrine hydrochloride in the form of 7 pellets inserted one month apart. The pellets were placed at the fundus during the proliferative phase of the menstrual cycle using a modified IUD inserter. Women were asked to report any unusual observations or side effects and instructed to use a barrier method or safe period for one month from the time of the first insertion. Follow-up was scheduled at 3, 6 and 12 months after the date of the second insertion and every 6 months thereafter. Results: Sixty-six women have been monitored for up to 3 years and follow-up of all patients continues. There has been no loss to follow-up. No side effects of any consequence have been reported. Thus far, no pregnancies have been reported for this protocol. Conclusions: Findings in this study are consistent with those seen in other countries. QS has been shown to be safe, effective and acceptable among Libyan women.
Quinacrine Sterilization (QS) in a Private Practice in Daytona Beach, Florida: A preliminary report R.B. Whitney Medical Director Keywords: nonsurgical female sterilization, quinacrine sterilization, private practice Synopsis: This QS series, initiated in October 2000 in an American office setting, has produced results similar to those reported by QS researchers worldwide. Corresponding author: Dr. R. B. Whitney Abstract (Go to full pdf article) Objectives: To affirm that QS can be performed safely and effectively in a U.S. private office practice. Methods: The U.S. FDA Modernization Act of 1997 Pharmacy Compounding Provisions made it possible for American physicians to begin offering QS to their patients. These provisions became effective November 21, 1998. This series was initiated in October 2000. The standard protocol recommended by the International Federation for Family Health (IFFH) is followed. Information on patients is recorded on forms suggested by IFFH to accomplish good post-marketing surveillance. The potential role of uterine septae in QS failures is of particular interest to this investigator. Results: Seven cases have been completed. There have been no failures. Side effects have been minor. Women have been exceptionally happy with this method. The Florida Agency for Health Care Administration has examined QS and found it to be an acceptable off-label use of quinacrine. Conclusion: Preliminary results have been similar to those reported by QS researchers around the world.
Quinacrine sterilization (QS) experience in The Philippines: a preliminary report L.A. Alfonso, H.A. Albano Department of Obstetrics and Gynecology Key words: female sterilization, quinacrine sterilization, nonsurgical sterilization Synopsis: This is a preliminary report on a QS trial in Cebu City, Philippines. Results of 36 women with 515 woman-months of use are most encouraging. Corresponding author: Dr. Lydia Alfonso Abstract (Go to full pdf article) Objective: The first clinical trial of Quinacrine Sterilization (QS) in the Philippines was undertaken in Cebu City on January 10, 2000, to evaluate the acceptability, safety, effectiveness and side effects of this technology. We intend to recruit 500 patients to utilize this technique for limiting family size. For the purposes of this report, our cut-off date is April 11, 2003. Methods: Over more than two years, QS was performed on 36 volunteer patients. After careful explanation of the procedure and given the opportunity to ask questions, they had signed an informed consent. The trial involved transcervical insertion of 252 mg quinacrine in the form of pellets, and placed at the tip of the uterine fundus on two occasions, a month apart. Condoms were routinely provided to all patients except those on oral contraceptive pills and DMPA after the first insertion to be used for six weeks after the second one. As the numbers are small, no statistical evaluation was called for. Results: The accumulated experience was 515 woman-months. There were no pregnancies, neither ectopic nor intrauterine. Adverse events (AE) were mild. Some patients complained of a yellow discharge and itching. Fifty percent experienced mild abdominal discomfort which was easily managed with mefenamic acid. Conclusions: Although this is a small study, we believe that QS is both safe and effective and we are strongly encouraged to continue to offer this nonsurgical sterilization method to our patients.
Marie Stopes Society, Pakistan: 1000 cases of quinacrine sterilization (QS) Bilgrami M1, Shah L2 1Managing Director 2Technical Advisor Key words: nonsurgical sterilization, quinacrine sterilization, female sterilization Synopsis: 1000 QS cases were studied at 23 sites in the outskirts of Karachi. After 4 years of follow-up, the crude pregnancy rate was 2.0%. Side effects were minor. Abstract (Go to full pdf article) Objectives: To evaluate the safety, efficacy and acceptability of QS in Karachi, Pakistan. Methods: 1000 women who had chosen sterilization during the 4-year period 1994 to 1997 inclusive were offered QS at both stationary clinics and in a mobile van at 23 sites in the outskirts of Karachi. The protocol involved transcervical insertion to the uterine fundus of 252 mg quinacrine in 7 pellets and 55 mg of ibuprofen in 3 pellets through an IUD inserter, during the proliferative phase of the menstrual cycle. Two doses were administered one month apart. A temporary method of contraception was provided for 3 cycles, usually DMPA. Follow-up was scheduled: monthly for 3 months, quarterly for 1 year and then every 6 months for 4 years. Results: The crude pregnancy rate after 4 years was 2.0%. Minor complications and complaints were reported by 59% of the patients. There was one ectopic pregnancy and no major complications. Conclusions: QS was found to be safe and effective and has become the most popular method of sterilization in our area of Pakistan.
T. Agoestina Department of Obstetrics and Gynecology Key words: quinacrine sterilization, nonsurgical sterilization, female sterilization Synopsis: After 7 years, among 70 women receiving one insertion, 14.3% became pregnant; there were no failures among 30 women receiving 2 insertions. No long-term side effects or complications were identified. Corresponding author: Dr. Tina Agoestina Abstract (Go to full pdf article) Objective: To evaluate the efficacy of one vs two insertions of quinacrine and the long-term safety of quinacrine sterilization (QS) 7 years after the procedure in Indonesia. Methods: Between March 1993 and September 1995, a randomized trial was conducted in 6 academic centers in Indonesia. In February 2003, a follow-up study was undertaken in Bandung, one of those centers. This survey required a home visit of each woman. A questionnaire was designed to elicit information regarding current general health status, method failure, pregnancy outcomes and other contraceptive methods now used by women who experienced failures. Among the 70 patients receiving a single insertion of quinacrine pellets, 14.3% had become pregnant. There were no pregnancies among the 30 who received 2 insertions. All the women were found to be in good health. No long-term side effects or complications were identified. Conclusion: The two-insertion protocol is unmistakably superior to the single insertion. This study provides further evidence that QS is a safe contraceptive method.
Quinacrine sterilization (QS) in Syria: a preliminary report on 297 cases V. Garabedian Private Practice Key words: quinacrine sterilization, nonsurgical sterilization, female sterilization Synopsis: From July 2001 to December 2002, 297 cases of QS were performed. Four women experienced severe pain while other side effects were mild. The one pregnancy was ectopic. Corresponding author: Vanig Garabedian, M.D. Abstract (Go to full pdf article) Objectives: To evaluate the safety, efficacy and acceptability of quinacrine sterilization (QS) in Syria. Methods: From July 2001 to December 2002, 297 women who requested permanent sterilization volunteered for QS either in my private practice or my local family planning center in Aleppo, Syria. The standard protocol was used: 252 mg of quinacrine in the form of 7 pellets are deposited at the uterine fundus with a modified CuT IUD inserted during the proliferative phase of the menstrual cycle. This procedure is repeated 4 weeks later. DMPA was injected at the time of the first insertion for temporary contraception. Every sterilized woman has had a monthly checkup visit until the cut-off date for this report including a beta HCG pregnancy test. All procedures were performed by the author. The cut-off date for this report was June 11, 2003. Results: The single pregnancy was ectopic. Four women (1.3%) complained of severe pain. Moderate pain was experienced by 13.1% while the remaining women felt mild pain, all easily treated. The remaining side effects were minor and also easily treated. Oligomenorrhea and amenorrhea affected 29% of the women and lasted for several months. Immediate side effects are similar to reports from other researchers. Conclusions: Results thus far regarding efficacy are encouraging. QS has proven to be acceptable.
A. Suhadi,1 M. Anwar,2 A. Soejoenoes3 1Department of Obstetrics and Gynecology, Wonosobo General Hospital, Wonosobo, Central Java Key words: Quinacrine sterilization, nonsurgical sterilization, female sterilization Synopsis: In this QS study of 200 women, the 10-year cumulative life table failure rate was 4.3 per 100 woman-years with a continuation rate of 93%. No long-term complications or side effects were identified. Corresponding author: Agung Suhadi, MD Abstract (Go to full pdf article) Objectives: To evaluate the safety and efficacy of quinacrine sterilization (QS) in Indonesia. Methods: During the period, August 1992 to October 1993, 200 women who had requested surgical sterilization volunteered for QS at the Wonosobo Regency Hospital, Central Java Province, Indonesia. The protocol called for transcervical insertion of 252 mg of quinacrine in the form of 7 cylindrical pellets and 55.5 mg of ibuprofen with a CuT-IUD (Kimia Farma) inserter during the proliferative phase of the menstrual cycle. A second procedure was done 4 weeks later. The technique used is essentially the same as inserting a CuT-IUD. Follow-up was scheduled at 6, 12, 24 and 48 months after the last insertion. In March 2003 additional monitoring was completed. Results: The 10-year cumulative pregnancy rate was 4.3 per 100 women with a follow-up rate of 93%. No pregnancies had occurred among these women since the 4-year follow-up. No long-term side effects or complications were reported. Conclusions: After 10 years of use, QS was found to be safe and reasonably effective.
Quinacrine sterilization (QS) in Costa Rica: 694 cases F. Alpizar Department of Obstetrics and Gynecology (retired) Key words: Quinacrine sterilization, nonsurgical sterilization, female sterilization Synopsis: From 1989 until August 1993, 694 cases of QS were performed in a private practice in Alajuela, Costa Rica. The gross failure rate was 2.5%. Side effects were minor. Corresponding author: Fernando Alpizar, MD Abstract (Go to full pdf article) Objectives: To evaluate the safety, efficacy and acceptability of quinacrine sterilization (QS) in Costa Rica. Methods: From 1989 though August 1993, 694 women volunteered for QS in my private practice. All were referred by a family planning clinic or a local hospital obstetric service. The protocol used involved the transcervical insertion of 216 mg of quinacrine hydrochloride in the form of 6 pellets. A second dose was given 4 weeks later. All insertions were done in the first 14 days of the menstrual cycle. The procedure was similar to the CuT IUD placement. Temporary contraception was recommended for 3 months after the last insertion. The cut-off date for this analysis was April 1994. Results: With 7 months to 5 years of follow-up, the gross pregnancy rate was 2.5%. Side effects were relatively minor, none requiring hospitalization. Conclusion: QS was found to be safe, effective and acceptable.
Quinacrine Sterilization (QS): Informed Consent Note to Readers: This questionnaire had more than 30 authors. It is the product of an initiative to create the best possible consent form for quinacrine sterilization (QS). From the beginning, the goal of the designers of this document has been to do our best to insure that women are so well informed about the procedure and its sequellae that they will be content with their decision whether or not to undergo QS. One contributor to developing this consent form was the late Dr. Michael Burnhill, Vice President for Medical Affairs, Planned Parenthood Federation of America. He played a key role in advancing the acceptance of QS in the United States and bringing this method to American women and consequently to women everywhere. This article is dedicated to Dr. Burnhill. Key words: Quinacrine sterilization, female sterilization, non-surgical sterilization Synopsis: A prototype consent form for quinacrine sterilization has been developed and extensively evaluated. It is available electronically and can be easily modified to fit local circumstances. Corresponding author: e-mail: editor@quinacrine.com Abstract (Go to full pdf article) Informed consent is a basic human right for any medical procedure. It is particularly important that women know what is involved in any sterilization method, and how it will affect their health and their emotional life. Over 130,000 QS procedures have been performed in 34 countries. In no country has there been any formal effort to advance the acceptance of this method. Instead, satisfied users have been the promoters. Thoroughly informed consent is vital to patient satisfaction. A working group undertook an initiative to create an ideal consent form. The product of that initiative is presented.
W.Lu1, J. Zhu2. 1Center for Research on Population, Guizhou University, Guiyang, Guizhou Province, China; Objective: Compare the safety, effectiveness and acceptability of quinacrine sterilization (QS) and surgical sterilization (TL) after 5 years of follow-up. Methods: This trial was initiated in July 1995 and intake was completed in September 1997. The first 300 women receiving QS in this province were followed for an average of 66.5 months. Results are compared to a randomly selected control group of women who had obtained a surgical sterilization in the same districts during the same time period and were followed for an average of 65.8 months. The first author interviewed each of the women in their homes and administered a structured questionnaire. Results: The follow-up rate was 98.3% for the QS group and 99.7% for the TL group. Three of the 26 women receiving a single quinacrine insertion became pregnant (12%) while 5 of the 268 receiving 2 insertions became pregnant (1.9%). Four of the 299 women in the TL group became pregnant (1.3%). There were no life-threatening complications or injuries in either group. QS was found to be acceptable and favored over surgical sterilization. Conclusions: Both QS and TL were found to be safe and effective. QS was found to be acceptable and preferred over TL.
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