Contraception for the older woman: an update.

Although fertility declines with advancing age as the woman approaches the menopause, some risk of pregnancy persists, and effective contraception needs to be offered to avoid an unintended pregnancy. An older woman may have menstrual dysfunction or climacteric symptoms and these factors would need consideration when making the choice of contraception. Low-estrogen dose combined oral contraceptives may be prescribed to healthy non-smoking women up to about 50 years of age. The progestogen-only pill may be an appropriate option in an older woman with declining fertility. The copper intrauterine device is an optimal method for parous women free of pre-existing menstrual problems. The levonorgestrel-releasing intrauterine system is considered the contraceptive method of choice for perimenopausal women with menstrual dysfunction. The woman should be provided with individualized advice so that she has a choice between the newer, effective, largely safe, reversible methods and sterilization.

Levonorgestrel intrauterine system (LNG-IUS) with conjugated oral equine estrogen: a successful regimen for HRT in perimenopausal women.

BACKGROUND: This study was designed to assess the long-term efficacy (5 years) of the levonorgestrel-releasing intrauterine system (LNG-IUS) in protecting the endometrium from hyperplasia during estrogen replacement therapy in perimenopausal women. METHODS: Prospective, open, outpatient clinical trial in London and Oxford. Eighty-two women received oral conjugated equine estrogen 1.25 mg daily and LNG-IUS releasing 20 mug levonorgestrel per 24 h. Endometrial biopsy and histological assessment were performed annually. Endometrial thickness was measured by vaginal ultrasonography. RESULTS: Non-proliferative endometrium was present at the end of cycles 12, 24, 36, 48 and 60 in 98.6, 98.6, 95.5, 96.8 and 95.2% of the participants respectively. No endometrial hyperplasias were confirmed throughout a period of 60 cycles. The proportion of amenorrhoeic women increased from 54.4% at 12 cycles to 92.7% at the end of the study. The continuation rate per 100 women at 60 cycles was 79.84 (95% CI 71.0-88.6). CONCLUSIONS: The LNG-IUS with estrogen supplementation in perimenopausal women suppresses endometrial proliferation resulting in amenorrhoea and relieves vasomotor symptoms. The treatment regimen is well tolerated and provides an alternative strategy for perimenopausal women with the likelihood of increasing compliance.

Depot medroxyprogesterone and bone mineral density.

OBJECTIVE: To investigate depot medroxyprogesterone (DMPA)-associated bone loss in a general practice setting. DESIGN: Forty-eight patients from a single practice who had used DMPA for contraception for more than 2 years. All patients had a serum oestradiol and if the serum level was <52 pmol/l or >52 pmol/l with menopausal symptoms, bone mineral densitometry (BMD) measurements were made at the lumbar spine (LS) and femoral neck (FN) using dual-energy x-ray absorptiometry (DEXA). Thirty-two patients had bone densitometry, of whom 27 had a serum oestradiol <52 pmol/l and five >52 pmol/l associated with menopausal symptoms. Of the remaining 16 patients, nine patients had a serum oestradiol <52 pmol/l but did not have a BMD as they moved away (five women) or switched to another contraceptive (four women). RESULTS: BMD results showed a significantly reduced bone mass at both sites with mean Z score LS -0.84 (95% CI -1.17 to -0.52) and FN -0.32 (95% CI -0.62 to -0.02). Eighteen women (56% of 32 women) had either osteopenia (15 cases) (T score < -1.0) or osteoporosis (three cases) (T score < -2.5) at the LS. There were trends to an association of a family history of height loss or tobacco smoking (current or past) for LS and FN Z scores that did not quite achieve significance. There was also a trend to lower body weight in those with a possible family history of osteoporosis or who were smokers and an inverse correlation of weight with BMD at the FN (p < 0.05) and a non-significant inverse correlation at the LS. CONCLUSION: The present results demonstrate that a low bone mass should be considered in patients with prolonged DMPA usage especially if they have risk factors for osteoporosis.

The effect of stopping smoking on cervical Langerhans' cells and lymphocytes.

OBJECTIVE: To investigate the effects of stopping smoking on cervical Langerhans' cells and lymphocytes. DESIGN: Prospective intervention study. SETTING: A large family planning clinic in central London. POPULATION: Women volunteers prepared to attempt to give up smoking for six months. Their most recent cervical smear showed no abnormality greater than mild dyskaryosis. METHODS: The women were seen at three-month intervals for six months. Reduction in smoking was assessed by self-reporting and validated by salivary cotinine concentrations. Colposcopy and a biopsy of a normal area were performed at the first and last visits. Any area of abnormality was also biopsied at the final visit. Langerhans' cells and lymphocytes were counted. MAIN OUTCOME MEASURES: Proportional changes in counts of Langerhans' cells and lymphocytes with reduction in smoking. RESULTS: Reduction in smoking by 20 to 40 cigarettes per day was significantly associated with a reduction of between 6% and 16% in counts of Langerhans cells, CD8 and total lymphocytes. Heavy smoking was significantly associated (P = 0.02) with an increased chance of persistent human papillomavirus infection. The presence of candida was associated with significantly higher counts of between 41% and 47% in total lymphocytes and CD8 lymphocytes. In contrast, the presence of anaerobic vaginosis was associated with significantly lower counts of between 16% and 30% in Langerhans cells, CD4 and CD8 lymphocytes. CONCLUSIONS: This large intervention study has demonstrated a clear relationship between reduction in smoking and changes in cervical immune cell counts. Future studies need to take into account cytokine interactions, which recent studies suggest may be significant in the immune response to both human papillomavirus and cervical intraepithelial neoplasia and the ever-increasing complexity of the cell-mediated immune system of the cervix.

How reliable is a vasectomy? Long-term follow-up of vasectomised men.

Around 42 million couples worldwide rely on vasectomy as a method of family planning. It is well recognised that a vasectomy can fall at any stage, and therefore warning couples of risk of failure forms an important part of the consent procedure.

Bone density in a population of long term oral contraceptive pill users does not differ from that in menstruating women.

Prevention of osteoporosis is a major public health issue. Amenorrhoeic women have lower bone density than normally menstruating women, which is related to the duration of amenorrhoea and the severity of oestrogen deficiency. Bone mineral density (BMD) in amenorrhoeic women can be improved by oestrogen replacement in the form of the combined oral contraceptive pill (COCP), so increased BMD might be an important non-contraceptive benefit of the COCP in menstruating women. Previous studies have been variably reported, but have used different methodologies for measurement of BMD. We measured BMD using the DEXA technique in long term COCP users and compared this with menstruating women who had never used the COCP. No differences in bone density were found, suggesting that the COCP does not improve bone mass in menstruating women who are adequately oestrogenised by their own ovaries.

Lea's Shield contraceptive device: pilot study of its short-term patient acceptability and aspects of use.

OBJECTIVE: To assess the short term patient acceptability and aspects of use of the Lea's Shield(R). DESIGN: Observational study. Ten women were each invited to use the Lea's Shield on 10 occasions and to report their observations and experiences on structured questionnaires after each use. Thus, data on a maximum of 100 uses would become available for analysis. Answers were recorded on numerical scales and in descriptive terms. On conclusion of their study participation, patients and their partners were required to document their overall experience with the product. SETTING AND SUBJECTS: Women aged 18 to 40 years, self-selected from clients attending the Margaret Pyke Family Planning Centre. They had to be in a stable monogamous relationship, gynaecologically healthy, and willing to continue their use of oral contraceptives, IUD, or injectable. MAIN OUTCOME MEASURE: Ability to use the method without formal teaching, assessed after vaginal examination by the investigator at end of first visit. User satisfaction, as expressed in structured questionnaires and by premature withdrawal from trial. RESULTS: Ten women used Lea's Shield on a total of 70 occasions, of which 46(66 per cent) were associated with sexual intercourse. Five subjects withdrew from the trial prematurely on account of discomfort to either or both partners (four), and recurrent cystitis (one). At the enrolment visit, all but one woman inserted the device correctly without formal teaching, but there was considerable inter-patient variation in their responses concerning ease of insertion/removal, and comfort during subsequent uses. CONCLUSIONS: These preliminary observations suggest that the Lea's Shield may be acceptable to a highly select minority of women. However, much more research is required to permit a reliable assessment of its acceptability to the wider public. The product's potential for causing pain and discomfort also needs further exploration.

PIP: The cup-shaped, reusable, one-size Lea's Shield barrier contraceptive is commercially available in Canada and a few European countries. In advance of its introduction to the UK, a study was conducted to assess the short-term acceptability of this device. Enrolled were 10 clients 18-40 years of age from the Margaret Pyke Family Planning Center in London, England, who used the device a total of 70 times, 46 of which were associated with sexual intercourse. Nine women inserted the device correctly on the basis of reading the manufacturer's instructions. However, five women reported continued problems with insertion and seven found removal to be difficult, suggesting a need for formal instruction in use of the device. Ease of insertion, ease of removal, and female comfort scores fluctuated widely between both participants and episodes of use, with no trend of progressive improvement over time. Four women discontinued the trial because of discomfort to themselves and/or their partner and another women withdrew because of recurrent cystitis. These generally negative responses may impact on the product's use effectiveness.

A risk-benefit assessment of the levonorgestrel-releasing intrauterine system.

The levonorgestrel-releasing intrauterine system (LNG-IUS), has been developed by Leiras Pharmaceuticals, Turku, Finland. It is a new systemic hormonal contraceptive that releases levonorgestrel 20 micrograms every 24 hours. The device provides fertility control comparable with that of female sterilisation, complete reversibility and convenience, and has an excellent tolerability record. The low dosage of levonorgestrel released by its unique delivery system ensures minimal hormone-related systemic adverse effects, which tend to be in the category of 'nuisance' rather than hazardous, and gradually diminish after the first few months of use. In some respects, the contraceptive characteristics of the LNG-IUS have over-shadowed a substantial range of noncontraceptive beneficial effects that are rarely seen with inert or copper-releasing intrauterine contraceptive devices (IUDs), and have important and positive gynaecological and public health implications. This applies particularly to the profound reduction in duration and quantity of menstrual bleeding, and alleviation of dysmenorrhoea, which are associated with the use of the device. Recent studies have shown that the LNG-IUS is effective in preventing endometrial proliferation associated with oral or transdermal estradiol therapy, and in inducing regression of endometrial hyperplasia. Further research is required to determine whether it has a role in regulating the growth of uterine fibroids, and preventing pelvic inflammatory disease. The unique unwanted noncontraceptive effects of the system, including possible development of functional ovarian cysts, and the relationship between menstrual bleeding pattern and ovarian function, also require better understanding, in order to offer appropriate patient counselling and maximise acceptability and continuation of use of the method.

PIP: The levonorgestrel-releasing intrauterine system (LNG-IUS) provides fertility control comparable to female sterilization, convenience, and complete reversibility. This method appears to combine the benefits of oral contraception and the IUD, while avoiding most of their side effects. The low level of LNG released (20 mcg every 24 hours) minimizes the systemic adverse effects associated with hormonal contraception. Unlike inert or copper IUDs, the LNG-IUS is associated with a profound reduction in the duration and quantity of menstrual bleeding and alleviates dysmenorrhea. Moreover, there is evidence that the LNG-IUS prevents the endometrial proliferation associated with estradiol therapy and induces regression of endometrial hyperplasia; its potential for regulating the growth of uterine fibroids and preventing pelvic inflammatory disease remains undetermined. Although large multicenter studies have not detected differences in cervical cytology or breast cancer incidence between copper IUD and LNG-IUS users, long-term epidemiological studies are needed to confirm this finding. Fundal positioning of the LNG-IUS is essential to ensure uniform exposure of the endometrium to the progestogen, prevent expulsion, and maximize efficacy. A promising future use for the LNG-IUS is in protecting the endometrium during postmenopausal hormone replacement therapy. Overall, the research suggests that the LNG-IUS comes close to meeting many of the requirements of an ideal contraceptive.

Oral contraceptives and the risk of DVT.

PIP: In the UK, the Committee for Safety of Medicines (CSM) issued a warning in October 1995 about the possible increased risk of nonfatal deep venous thrombosis (DVT) among users of oral contraceptives (OCs) containing the third generation progestogens, desogestrel and gestodene. Subsequent media coverage increased the number of consultations and enquiries about these OCs. CSM had concluded that, overall, the third generation OCs are safe. CSM recommended their continued use. Nevertheless, many women stopped using them and induced abortions increased by 11%. In April 1996, the Committee for Proprietary Medicinal Products issued a more cautious statement about the OCs and called for further evaluation. Chance, confounding, and bias may account for the increased risk observed in the studies in question. Yet, it is possible that these OCs may increase the risk of DVT. The increased risk may be offset by a reduced risk of acute myocardial infarction. Physicians need to conduct careful and thorough counseling and to allow the patient to be involved and to take responsibility in making a decision about OC use. They should document all counseling with a note that the patient understands and accepts the increased risk of DVT. They should not prescribe the third generation OCs to women with any of the absolute contraindications to OC use (ischemic heart disease, hypertension, atherogenic lipid disorders, focal or crescendo migraine, cigarette smoking, transient ischemic attacks, past cerebral/subarachnoid hemorrhage, history of vascular thrombosis, prothrombotic abnormalities [e.g., Factor V Leiden], conditions predisposing to thrombosis [e.g., systemic lupus erythematosus], and obesity. Women who are intolerant of second generation OCs may prefer third generation OCs. Physicians should selectively screen women with a family history of a first-degree relative younger than 45 with thromboembolism for Factor V Leiden. They should also screen for protein C, protein S, and antithrombin III deficiency and for acquired antiphospholipid antibodies.^ieng

Effect of smoking cessation on cervical lesion size.

BACKGROUND: Cigarette smoking has been postulated as a cofactor in the aetiology of cervical cancer, but a causal role is difficult to establish because of potential confounding by sexual behaviour. We have investigated the effect of cessation or reduction of cigarette smoking on the course of minor-grade cervical lesions. METHODS: In this intervention study 82 women volunteers with minor-grade lesions on colposcopy (cervical intraepithelial neoplasia grade 1 or less) attempted to give up smoking for 6 months. Smoking histories were taken at 3-monthly clinic visits and verified by measurement of salivary cotinine concentrations. At each clinic visit, a photograph of the cervix was taken; the image was digitised and computer-aided image analysis was used to assess lesion size, by investigators unaware of smoking status. FINDINGS: Of the 82 women, 17 stopped smoking completely for at least 6 months and 11 others reduced their smoking consumption by more than 75%. Of these 28 women, 23 (82%) showed a reduction in lesion size of at least 20% or 4 mm2 compared with 13 (28%) of the 47 non-quitters (odds ratio 12.0 [95% Cl 3.9-32.7]). The remaining seven women had unconfirmed smoking histories. There was a significant correlation between the extent of smoking reduction and the change in lesion size (chi2 for trend=31.55, p<0.0001). Adjustment for social class, method of contraception, and stage of menstrual cycle did not affect the results. INTERPRETATION: Our findings support a link between smoking and cervical disease and suggest that smoking cessation could have a beneficial effect on early cervical abnormalities.

Human papillomavirus testing in primary cervical screening.

Several studies have examined the role of tests for human papillomavirus (HPV) in screening for cervical cancer but as yet the relevance is unclear. We looked at HPV testing for types 16, 18, 31, and 33 on material taken at the time of a cervical smear in 2009 eligible women having routine screening. Women with any degree of dyskaryosis or high levels of one of these HPV types were referred for colposcopy. 44% of the cervical intraepithelial neoplasia (CIN) lesions of grade 2/3 detected had negative cytology and were found only by HPV testing. A further 22% of the CIN 2/3 lesions were positive for HPV but showed only borderline or mild cytological changes. The positive predictive value of HPV testing was 42%, which was similar to that for moderate dyskaryosis. HPV types 16 and 31 were more sensitive and specific for CIN 2/3 than were types 18 or 33. However, 25% of the CIN 2/3 lesions were not detected by these four HPV tests. We suggest that HPV testing could usefully augment but not replace conventional cytology. These results should stimulate a much larger randomised trial to assess the impact of these improved CIN 2/3 detection rates on the subsequent incidence of invasive cancer.

Comparison of four cytologic sampling techniques in a large family planning center.

In recent years, several new cervical sampling techniques have been introduced to try to improve the accuracy of the cervical smear. In the present study four such techniques were compared: the Aylesbury spatula, Rolon spatula, Cervex device and Aylesbury spatula used in conjunction with a Cytobrush. The total number of smears collected was 14,172, 80% of which were from women under age 35. Despite large differences between the techniques with regard to the presence of endocervical cells in smears, no differences were found in the detection of dysplasia. Endocervical cells were seen significantly more often in dysplastic smears than in negative smears. There was little difference in the rate of unsatisfactory samples. It appears that in a young population, the instruments used for cervical sampling are not likely to significantly influence the detection of dysplasia if skilled personnel take the smears.

Preliminary report of unexpected local reactions to a progestogen-releasing contraceptive vaginal ring.

This is the first report of vaginal erythematous areas associated with the use of a levonorgestrel-releasing contraceptive ring. Of 139 female subjects, 48 developed lesions of varying size and degrees of redness. Sixteen of these have undergone serial colposcopy and thirteen have also had biopsy examinations, which revealed acetowhite areas and, histologically, chronic inflammation with widely dilated vessels and frequently with thinning of the epithelium. The cause remains uncertain but hormonal, chemical and physical effects might all have a role.

PIP: Between August 1990 and May 1992 in London, England, researchers enrolled 139 women aged 18-40 years in a clinical trial of a levonorgestrel-releasing contraceptive vaginal ring. All the women had a negative cervical smear. They underwent a thorough initial gynecological examination (i.e., visualization of entire vaginal area and the cervix). Clinicians reexamined them at 6 weeks, 3 months, and a 3-month intervals thereafter. 48 women (34.5%) had erythematous lesions on at least 1 occasion. They were at the vaginal vault, and sometimes on the cervix, where the vaginal ring usually lies. Most women had no symptoms. All the women were unaware that they had lesions. The lesions disappeared spontaneously in 16 women (33.3%) with the vaginal ring still in place. During colposcopy with vaginal ring in place, a clinician took vaginal/cervical swabs in 16 women to test for common sexually transmitted diseases (STDs). All but 1 woman tested negative for STDs. The erythematous lesion responded to 5% acetic acid in 14 of the 16 women, indicating an abnormality. Clinicians took biopsies in 13 of these women and did repeat colposcopy at 3-4 week intervals. Histological examination showed congestion with considerable dilated vessels, chronic inflammatory changes of varying severity, and frequent intracellular edema of the squamous mucosa. The mucosa was abnormally thin in some women, while in others it was entirely missing. Changes in 4 women were caused by HPV. 1 woman had grade 1 cervical intraepithelial neoplasia (CIN). The researchers could not conclude that the HPV-induced changes or CIN occurred during vaginal use because the women were not colposcoped before entry into the study. All of the study's findings prompted the ethics committee to halt the study in May 1992. In July 1992, the manufacturer shut down the entire UK study, stating that accumulation of enough data on efficacy and acceptability had been achieved. Further research is needed to determine what caused the lesions.

Combined oral contraceptives: acceptability and effective use.

With over 60 million users of 'the pill' worldwide, safety and efficacy remain the two most relevant issues to both the consumer and the research scientist. Safety of combined oral contraception (COC) has advanced appreciably. Lessons learned from cohort and case-control studies have been applied to the practical management of oral contraception use, based on screening, selection and regular monitoring of users. Most health risks of COCs appear to be dependent on the dose and potency (or biological impact) of the constituent steroids. While many of the non-contraceptive benefits of COCs are maintained when modern low dose preparations are used, most, if not all, of the adverse effects have been reduced progressively. Moreover the range of modern hormonal contraceptives has widened with the introduction of a new generation of 'selective' progestogens (Desogestrel, Norgestimate and Gestodene), which have minimal androgenicity. User failure of COCs is still high in many countries. The cause is a combination of poor compliance and anxiety about perceived adverse effects. Compliance can be enhanced by improving the quality of instruction in pill use. Fears of adverse effects of COCs may be allayed through education of users and providers, and sympathetic management of side effects.

PIP: After the development of monophasic combined oral contraceptives (COCs), containing a fixed dose of estrogen and progestogen, biphasic and triphasic COCs were introduced in the 1980s; in these the dose of ethinyl estradiol and progestogen changes during the pill cycle. In the so-called every day pills, the 21 pills of active steroid combination are followed by 7 inactive pills containing starch, iron, or bran. Method failures of OCs are among the lowest ranging from 0.2-1/100 woman-years. User failures can be as high as 6.2/100 women-years. The individual difference in peak plasma levels of estrogens in women taking identical OCs can be 10-fold. Conditions that affect the bioavailability of contraceptive steroids are: 1) drug interaction (vitamin C, drugs that induce liver enzymes, and antibiotics); 2) vomiting; 3) vegetarianism; 4) missing pills; and 5) malabsorption. Metabolic effects of COCs pertain to carbohydrate metabolism, lipid metabolism, hemostasis, and vitamins. Prescribing of COCs involves counseling clients about contraindications to COCs, starting routines, and the pill-free interval, as well as follow-up and monitoring, the problem of missing pills, and selection criteria for OC use. Medical conditions in which COC use requires special consideration are sickle cell disease, trophoblastic disease, HIV disease, gallstones, epilepsy, valvular heart disease, oligomenorrhea/amenorrhea, inflammatory bowel disease, and surgery. Side effects of COCs may include depression, nausea, vomiting, headaches, urinary tract infection, and lower genital tract infections. 6 months after stopping the OC 1% of users become amenorrheic. Many of the common causes of amenorrhea, such as weight loss amenorrhea and polycystic ovarian disease, may be treated with the COC until the couple desires to have a baby. The new progestogens desogestrel, norgestimate, and gestodene are highly selective compared to first and second generation progestogens.

Changes in haemostasis after stopping the combined contraceptive pill: implications for major surgery.

OBJECTIVE: To investigate the changes in haemostasis in the three months immediately after stopping the combined contraceptive pill. DESIGN: Prospective randomised study. SETTING: Family planning centre in London. SUBJECTS: 24 women aged 35-45 investigated before, during, and after six months' use of combined oral contraceptives containing 30 micrograms ethinyl oestradiol together with the progestogens desogestrel or gestodene. MAIN OUTCOME MEASURES AND RESULTS: Blood samples were taken immediately before and after six months of oral contraceptive use and one, two, four, six, eight, and 12 weeks after the pill had been stopped. During the six months of oral contraceptive use the plasma concentration of factor X and fibrinogen increased and that of antithrombin III decreased. Between two and six weeks after stopping the pill a rebound phenomenon occurred with plasma concentrations of antithrombin III increasing (mean change from baseline at two weeks 0.06 IU/l and at six weeks 0.10 IU/l) and fibrinogen decreasing (0.26 g/l change at two weeks and 0.40 g/l at six weeks). Factor X concentrations fell gradually and the values at eight weeks were not significantly different from those found before the combined pill was started. CONCLUSION: The combined pill should be stopped at least four weeks before major surgery, which carries the risk of postoperative thrombosis, to allow the potentially prothrombotic haemostatic changes that occur during its use to be corrected.

PIP: This study investigated the changes in hemostasis in the 3 months immediately after cessation of the combined oral contraceptive (OC). This prospective, randomized study has based at a family planning center in London and 24 women, ages 35-45, were investigated before, during, and after 6 months use of these combined OCs containing 30 mcg ethinyl estradiol along with the progestogens desogestrel or gestodene. Blood samples were taken immediately before and after 6 months of OC use and 1,2,4,6,8, and 12 weeks after the pill had been stopped. During the 6 months of OC use, the plasma concentration of factor X and fibrinogen increased and that of antithrombin III decreased. Between 2-6 weeks after stopping the pill, a rebound phenomenon occurred with plasma concentrations of antithrombin III increasing (mean change from baseline at 2 weeks 0.06 IU/l and at 6 weeks 0.10 IU/l) and fibrinogen decreasing (0.26 g/l change at 2 weeks and 0.40 g/l at 6 weeks). Factor X concentrations fell gradually and the values at 8 weeks were not significantly different from those found before the combined pill was begun. The combined OC should be stopped at least 4 weeks prior to major surgery (which carries the risk of postoperative thrombosis) in order to allow the potentially prothrombotic hemostatic changes that occur during its use to reverse themselves.

Mass laparoscopic sterilizations.

PIP: An account is given of an observation of mass laparoscopic sterilizations done by Dr. P. Mehta, an Indian surgeon who claims to have performed 250,000 female sterilizations in less than 10 years. His record is 156 procedures in just under 2 hours. This observation and videotaping session took place in a rural setting, with the women lined up on benches on the verandah of Belpukur College. The 150 operations were completed in about 4 hours, with the help of a large team of assistants. An independent audit of Dr. Mehta's patient records has produced no failures or complications, nor have there been any claims by relatives for the Rs. 10,000 payment for a patient who has died after laparoscopic sterilization by Dr. Mehta. It was recommended that Dr. Mehta do the following to improve the safety of his mass sterilizations: 1) provide counseling in the form of an information leaflet for each candidate; 2) have a female nurse give each woman a preliminary pelvic exam (none are given now because local women will not accept male examiners); 3) give the premedications pre-mixed in a single, separately sterilized needle and syringe, sufficiently early for the anesthetic to take effect, as by an assistant 30 women ahead of the current patient; 4) aspirate the puncture needle to ensure that it is not in an abdominal vessel or cyst; 5) improve the procedure of cleaning and sterilizing the trocar and laparocator, using clean soapy water with chlorine, clean boiling water, and formaldehyde gas if any blood had contaminated the instruments; 6) carry each woman on a stretcher to the recovery area; 7) finally, have Dr. Mehta greet each woman by name. It would also be beneficial if Dr. Mehta could take time to train others in his technique.^ieng