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Biomedical subjects

E Kessel

Publications and source records attributed to E Kessel.

At least 19 recordsLinked to original sources
PubMed2003

Quinacrine sterilization: a retrospective.

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.

Animals↗
PubMed1998

Quinacrine sterilization: an assessment of risks for ectopic pregnancy, birth defects and cancer.

Quinacrine sterilization (QS) involves transcervical insertion of quinacrine pellets using a modified Copper TIUD inserter. Pellets are placed at the fundus in the proliferative phase of the menstrual cycle. Efficacy is presently estimated at 1 pregnancy failure per 100 women at 2 years. Early complications are lower for QS than surgical sterilization and this is also true for risk of ectopic pregnancy with newer insertion protocols. The risk of birth defects is very low, when estimated from a model with reasonable assumptions for probability of insertion in a pregnant uterus or within 30 days of conception, probability of such exposed pregnancy being carried to term, and probability of quinacrine exposure to the fetus causing a birth defect. Although quinacrine is a mutagen it is unlikely to be a carcinogen. Concentrations of quinacrine in the uterus after transcervical insertion are higher than for oral administration for only a matter of a few hours, although this brief exposure is adequate to cause injury to the tubal epithelium, leading to inflammation and an occluding scar. Oral administration of quinacrine is accepted as non-carcinogenic. Each site of use of QS must make its own risk/benefit assessment. The benefits of any contraceptive that can raise contraceptive prevalence is greatest for developing countries.

Abnormalities, Drug-Induced↗
PubMed1996

100,000 quinacrine sterilizations.

100000 quinacrine nonsurgical female sterilizations have been completed over the past decade involving transcervical insertion of quinacrine (252 mg) as pellets by one, two or three monthly insertions. No deaths have been reported and serious complications are far fewer than for surgical sterilization. Side-effects are mild and transient. Efficacy has improved from 3 pregnancy failures per 100 women at one year to approximately 1 by improved insertion technique and use of adjuvants. Long-term follow-up of early cases in Chile shows no increased risk of cancer for this method. The main advantage of quinacrine sterilization is its ability to raise contraceptive prevalence and thereby reduce maternal mortality and morbidity, especially in rural and urban slum areas of developing countries. It should be made available as an option to well informed women everywhere as an economical and safe permanent family planning method.

Developed Countries↗
PubMed1995

A potential single insertion protocol for quinacrine pellet non-surgical female sterilization.

Two preliminary single-insertion clinical trials of the quinacrine pellet method of non-surgical female sterilization were compared. Both trials used transcervical application of quinacrine, 252 mg, and diclofenac, 75 mg, as pellets. In the first trial (21 April 1992 to 17 February 1993), 58 women received oral contraceptives for three months. In the second trial (19 February 1993 to 25 May 1994), 229 women received medroxyprogesterone acetate, 150 mg IM, at the time of quinacrine insertion. At 18 months, the life-table pregnancy failure rate per 100 women of the first trial was 8.6 (SE 3.7), whereas the failure rate for the medroxyprogesterone acetate group was 0.5 (SE 0.5), p<0.05. There were no serious complications or side-effects in either group. Larger confirming trials with random allocation and long-term systematic follow-up are needed to determine whether a single injection of medroxyprogesterone improves the efficacy of quinacrine.

Cervix Uteri↗
PubMed1995

Comparison of the efficacy of intrauterine diclofenac and ibuprofen pellets as adjuvants to quinacrine nonsurgical female sterilization.

To investigate relative efficacy of intrauterine diclofenac and ibuprofen as adjuvants to intrauterine quinacrine for nonsurgical sterilization, a total of 900 women were systematically allocated to 2 monthly insertions of pellets of diclofenac (75 mg) or ibuprofen (55.5 mg) as adjuvants to intrauterine quinacrine (216 mg) in a rural private practice in West Bengal, India. All women were prescribed oral contraceptives for three months from first insertion. In the middle of the study increased care was taken to insert pellets at the fundus. There was no statistically significant difference found in cumulative life-table pregnancy failure rates at 36 months for women receiving diclofenac (2.7 +/- 0.82) or ibuprofen (3.4 +/- 0.89). Taking care to insert pellets at the fundus resulted in a decline of failures at 24 months from 4.4 +/- 0.92 to zero. Intrauterine administration of pellets of quinacrine (216 mg) plus diclofenac (75 mg) or ibuprofen (55.5 mg) with 3 months' oral contraception provides acceptable efficacy if pellets are inserted to the fundus.

Diclofenac↗
PubMed1994

Transcatheter tubal sterilization in rabbits. Technique and results.

RATIONALE AND OBJECTIVES: A potential method of nonsurgical tubal sterilization was tested in rabbits. METHODS: Metal coils were designed which could be placed into the uterotubal junction using transvaginal fluoroscopic fallopian tube catheterization. These metal coils were successfully placed unilaterally in the uterotubal junction of 32 rabbits. The contralateral fallopian tube and uterus were used as a control. The rabbits were bred, and the presence of pregnancies was confirmed by palpation. RESULTS: In 21 rabbits (66%), the coil stayed in place. Sixteen rabbits had multiple gestations on the side without the coil and no gestations on the side with the coil. Three rabbits had gestations on both sides, even though the coil was in place, and two rabbits never conceived. In 11 rabbits (34%) the coil was dislodged as early as 5 days and as late as 18 weeks after the procedure. Five of these 11 rabbits had bilateral embryos, 4 had embryos only on the side contralateral to where the coil had been, and 2 never conceived. CONCLUSIONS: The metal coil does prevent conception if it stays in place at the uterotubal junction. However, the coil failed to prevent pregnancy in 3 of 19 rabbits, and was dislodged in 11 rabbits, giving an overall failure rate for contraception of 44%.

Animals↗
PubMed1993

Efficacy and safety of repeated transcervical quinacrine pellet insertions for female sterilization.

OBJECTIVE: To investigate the rates of tubal occlusion, pregnancy, and side effects of repeated, monthly transcervical insertions of 252 mg quinacrine as pellets. DESIGN: Clinical trial among 159 reproductive age women receiving two monthly transcervical insertions of 252 mg of quinacrine followed by hysterosalpingograms (HSGs) 1 month after last insertion and an additional monthly insertion among women without evidence of bilateral tubal occlusion. Contraception of women's choice provided until bilateral tubal occlusion achieved, and surgical sterilization provided for women failing to achieve bilateral tubal occlusion after third quinacrine insertion. Women were followed for at least 24 months for evidence of pregnancy or side effects. RESULTS: Among the 159 women completing the protocol, 73% had evidence of bilateral tubal occlusion by HSGs after two insertions of quinacrine pellets and 94% after a third insertion. These 149 women were followed for 24 months without a pregnancy failure or serious side effect. CONCLUSION: Transcervical applications of quinacrine as pellets have potential for safe, effective, inexpensive, and easily deliverable female sterilization.

Adult↗
PubMed1992

Sterilization needs in the 1990s: the case for quinacrine nonsurgical female sterilization.

Much evidence suggests that demand for sterilization is a function of supply of surgical sterilization services in less-developed countries. If such services were greatly expanded, the number of procedures performed would grow dramatically. While the prevalence of sterilization is estimated to increase from 23.5% to 28.8% of married women of reproductive age in the 1990s, there will actually be 106,432,000 more couples of reproductive age at the end of this decade than at its beginning who use either no method or a far less effective method with much lower continuation rates than sterilization--nearly a 20% increase. To achieve a mean sterilization prevalence of 47% of married women of reproductive age in the less-developed world, as now seen in the Republic of Korea and Puerto Rico, the number of sterilizations would need to be more than double the current projection for the 1990s: 328,429,000 rather than 159,000,000. The quinacrine pellet method for nonsurgical female sterilization offers hope that this enormous shortfall in sterilization services can be overcome in this decade.

Adult↗
PubMed1992

Was the Dalkon Shield a safe and effective intrauterine device? The conflict between case-control and clinical trial study findings.

OBJECTIVE: To compare the findings of the case-control and cohort studies used to indict the Dalkon Shield (A.H. Robins Company, Inc., Richmond, VA) with the findings of the Dalkon Shield clinical trials. DATA IDENTIFICATION: All published reports on the Dalkon Shield were identified through MEDLARS system (United States National Library of Medicine) searches and by cross checking all references in these reports. The same approach was used to identify all case-control and cohort studies of the purported relationship between intrauterine devices (IUDs) and pelvic inflammatory disease (PID). STUDY SELECTION: Only studies of interval patients that included 50 or more women and 6 or more months of follow up that computed standard IUD event rates (rates of pregnancy and expulsion and removal for pain and bleeding) were selected for this study. All case-control and cohort studies identified were included except two case-control studies that included women with sterile chronic salpingitis. RESULTS: The 16 case-control and 2 cohort studies found or suggested that the Dalkon Shield increased the risk of PID. The 71 clinical trials of the Dalkon Shield show that when this device is inserted by an experienced clinician it is a safe and effective contraceptive method, comparable with other IUDs used at the time. There was no evidence of an increased risk of PID found in these clinical trials. CONCLUSIONS: This study offers convincing evidence that the indictment of the Dalkon Shield was a mistake. Additionally, this study shows that physician skill and experience is far more important to successful IUD insertion than previously recognized, a finding with considerable implications for IUD study designs and for marketing strategies.

Case-Control Studies↗