Lynda Painter Cole

Quinacrine hydrochloride pellets: preliminary data on a nonsurgical method of female sterilization.

The efficacy of transcervical insertions of quinacrine hydrochloride pellets to produce tubal occlusion has been evaluated in a study of 139 women in Santiago, Chile. At one year, the pregnancy rate was 3.1%, an acceptable rate for a nonsurgical method of female sterilization.

An evaluation of the TCu 380Ag and the Multiload Cu375.

The TCu 380Ag (Outokumpu Oy, Pori, Finland) and the Multiload Cu375 (Multilan, Organon, Oss, The Netherlands) were evaluated in 1477 women in a multicenter clinical trial. The intrauterine devices showed similar, low-event rates. Cumulative life-table pregnancy rates were less than 1.0, and continuation rates were approximately 90 per 100 women at 1 year after insertion. The risk of subsequent hospitalization or pelvic infection was low.

Incidence of pain among women undergoing laparoscopic sterilization by electrocoagulation, the spring-loaded clip, and the tubal ring

Data analyzed from five comparative studies show a relationship between the technique of tubal occlusion and pain experienced by patients both at the time of the procedure and during the recovery period. During the procedure, the spring-loaded clip is the technique least likely and the tubal ring the technique most likely to be associated with pain. During the recovery period, both the spring-loaded clip and the tubal ring are associated with higher rates of abdominal or pelvic pain than is electrocoagulation. Differences in pain that occurred during the recovery period did not persist to the early follow-up visit.

A three-year evaluation of TCu 380Ag and Multiload Cu 375 intrauterine devices.

A randomized, comparative, multicenter clinical trial of TCu 380Ag and Multiload Cu 375 intrauterine devices (IUDs) was conducted. Safety and acceptability were evaluated through three years following insertion in 884 patients. The two IUDs were similar with respect to all event rates. Thirty-six month life table pregnancy rates were 0.6 per 100 TCu 380Ag users and 1.8 per 100 Multiload Cu 375 users. Continuation rates were 67.4 and 61.4 per 100 users of the respective devices at three years after insertion.

Phase I Prehysterectomy Studies of the Transcervical Administration of Quinacrine Pellets

To determine the safety of transcervical administration of quinacrine pellets as a method of voluntary female sterilization, three noncomparative Phase I clinical trials of the administration of 250 mg quinacrine were carried out in 21 women who were scheduled to undergo hysterectomy 24 h or one month later. Detailed results are presented for one of the trials using 10-min pellets. Six of 10 women had minor transitory complaints during the postinsertion 24-h follow-up period. Five women reported pelvic/abdominal cramping, one experienced headache, and one experienced dizziness. Blood chemistry values were not adversely influenced by the quinacrine. The average plasma level of quinacrine peaked at 3 h, 36.1 ng/ml, slightly lower than the value observed 4 h after oral administration of 200 mg in a previous study. An average of 27% of the administered dose was recovered in tampons. Quinacrine was detected in the plasma of two women at the four/six-week visit. Selected results are presented from two other trials that were halted because of slow recruitment. The transcervical administration of 250 mg of 10-min quinacrine pellets was well tolerated. However, based on recent mutagenicity testing and meetings with regulatory officials, it appears unlikely that the use of quinacrine for nonsurgical sterilization could be approved in the United States or Europe.

A new approach to measuring menstrual pattern change after sterilization

Methodologic problems with previous research on menstrual changes after sterilization have resulted in conflicting results. This research overcomes these problems by restricting the categories of patients and by minimizing recall difficulties. When the methodologic approach is improved, the result is that the majority of women experience no change, and among those who do, changes in one direction are counterbalanced by changes in the other direction. Three cycles preceding sterilization were compared with three cycles 12 months after the operation for four menstrual parameters. The parameters were examined separately and simultaneously by means of an index of menstrual pattern changes. Rings and spring-loaded clips were associated with less change than other methods of occlusion. The most important variable was the patients menstrual pattern at the time of admission. Women defined as having abnormal patterns were three times more likely to experience change than women with normal cycles, and many of the former experienced change in the direction of normality.

Effects of Breastfeeding on IUD Performance

The effect that lactation might have on intrauterine device (IUD) performance was investigated by using data from a series of multicenter clinical trials. Life-table methods were applied to compare breastfeeding and non-breastfeeding women with respect to IUD expulsion, accidental pregnancy, IUD removal for various reasons, and overall continuation of IUD use. Results indicate that breastfeeding does not increase the risk of expulsion or other events, whether the device is inserted immediately (within ten minutes) or more than 42 days after delivery. (Am J Public Health 1983; 73:384-388.)

Risks and Benefits of Culdoscopic Female Sterilization

This paper reviews the risks and benefits of the culdoscopic approach to female sterilization in an analysis of 2153 culdoscopic sterilization procedures performed at 11 centers in nine countries. Inability to occlude the tubes as planned was reported for approximately 6.0% of the cases including 1.4% in which one or both tubes could not be occluded by any technique. Surgical difficulties were reported for about 13.0% of the procedures, and surgical complications, of which the most frequent was torn or bleeding tubes, occurred in 2.0% of the cases. Pregnancy rates were significantly higher for patients whose tubes were occluded by tantalum clips (7.7 per 100 women at 12 months), indicating that this is not the preferred technique of tubal occlusion; the 12‐month life table pregnancy rates were 0.1 per 100 women for tubal ring and 0.0 for Pomeroy and fimbriectomy. Comparison of these data with similar pooled data on laparoscopy and minilaparotomy indicates that culdoscopy is associated with greater technical difficulty and morbidity. Thus, abdominal procedures will continue to be preferred for use in most large‐scale programs.

Nonsurgical female sterilization.

The development of a safe, effective nonsurgical method of female sterilization that can be performed by paramedical personnel remains a high priority. The method should have a blind delivery system and require only one application. Methyl cyanoacrylate and quinacrine hydrochloride are the two most promising chemical agents. Quinacrine has evolved from instillations of a solution to the development of pellets to the use of an IUD vector. By using an IUD vector to deliver the quinacrine, tubal occlusion can be achieved with a reduction in total dosage and with one insertion instead of the three necessary with the solution and pellet methods.

Laparoscopic Electrocoagulation and Tubal Ring Techniques for Sterilization: A Comparative Study

From August 1975 through May 1976, a comparative study was made of the effects of sterilization by standard electrocoagulation and tubal ring application techniques. The two techniques were randomly assigned to 300 patients. Results show that standard electrocoagulation and tubal ring procedures can easily and safely be performed on an outpatient basis, using local anesthetics and analgesics. Rates of surgical complications for both techniques were clinically acceptable, although tubal ring patients had a higher rate. Pain during the procedure and during the immediate recovery period was more severe for tubal ring patients. Despite the higher incidence of surgical complications and pain associated with the ring, many physicians prefer this method of sterilization because it eliminates the possibility, inherent in electrocoagulation, of inadvertent serious electrical burns.