Susan Brechin

Male and female sterilisation

Summary Male and female sterilisation is used in many countries worldwide as a permanent method of contraception. Failure rates for female sterilisation are affected by age at sterilisation and by the method of tubal occlusion. Laparoscopic sterilisation has low complication rates but is unavailable in parts of the developing world due to the lack of facilities, equipment and expertise. Less invasive techniques are being developed, such as hysteroscopic tubal occlusion and administration of intrauterine agents. Failure rates for vasectomy are 10 times lower than those for female sterilisation. Complications such as pain, haematoma and granuloma formation may occur. Nursing staff and doctors can provide counselling prior to sterilisation. Failure rates, irreversibility, complications and alternative methods of contraception should be discussed and documented. Counselling should allow men and women to provide informed consent for sterilisation and reduce the incidence of regret and requests for reversal.

Male and female sterilization

Male and female sterilization is used in many countries worldwide as a permanent method of contraception. Failure rates for female sterilization are affected by age at sterilization and by the method of tubal occlusion. Laparoscopic sterilization has low complication rates but is not available in parts of the developing world due to the lack of facilities, equipment and expertise. Less invasive techniques are being developed, such as hysteroscopic tubal occlusion and administration of intrauterine agents. Failure rates for vasectomy are 10 times lower than those for female sterilization. Complications such as pain, haematoma and granuloma formation may occur. Nursing staff and doctors can provide counselling prior to sterilization. Failure rates, irreversibility, complications and alternative methods of contraception should be discussed and documented. Counselling should allow men and women to provide informed consent for sterilization and reduce the incidence of regret and requests for reversal.

Using formal consensus methods to adapt World Health Organization Medical Eligibility Criteria for contraceptive use.

BACKGROUND Most contraceptive users are medically fit and can use any available method. Some medical conditions are associated with theoretical safety concerns when certain contraceptives are used. Nevertheless, most contraceptive clinical trials exclude subjects with chronic medical conditions, and direct evidence on which to base sound contraceptive prescribing is limited. The World Health Organization (WHO) Medical Eligibility Criteria provide recommendations on the safe use of contraception. This document is aimed at policymakers and program managers working in less developed countries in which the risks of pregnancy usually far outweigh the risks associated with contraceptive use. STUDY DESIGN The Faculty of Sexual and Reproductive Healthcare used formal consensus methods to adapt the WHO document to reflect clinical practice and health care systems in the United Kingdom. CONCLUSION This structured group consensus method adds authority, rationality and scientific credibility to the UK version, which makes best use of published evidence and captures collective expert knowledge. Not all clinicians will agree with the recommendations made in the UK version of the Medical Eligibility Criteria, but for the vast majority, they will be a valuable reference to guide clinical practice for women with many conditions that theoretically affect contraceptive use.

Evidence-based reproductive health: testing times for treatments

Journal of Family Planning and Reproductive Health Care 2003: 29(3) Clinical scenario A 30-year-old woman consults you. She has been successfully using a progesterone-only pill (POP) containing levonorgestrel (LNG) (Microval®) but is anxious that her POP has a higher failure rate than her previous combined oral contraceptive pill (COC). She would prefer to continue some form of POP, having disliked depot medroxyprogesterone acetate (DMPA) in the past. She is unable to use combined oral contraception (COC) due to migraine with focal aura and has recently heard that a better POP is now available. You recall attending a recent update meeting on contraception where a couple of colleagues were enthusiastically advocating the new POP (Cerazette®), which contains 75 mg (microgrammes) desogestrel (DSG) and apparently has the efficacy of a COC. During lunch you had visited pharmaceutical company stalls and picked up the usual useful freebies, including some literature on Cerazette, a pocket calculator and a pen that writes a message backwards in Mandarin:

The members' enquiry service: frequently asked questions

The Clinical Effectiveness Unit (CEU) presents an illustrative response of a frequently asked question to the Members’ Enquiry Service on whether or not hormonal contraceptive use by women with a history of pregnancy-related cholestasis is safe or associated with recurrence of cholestasis. The Summaries of Product Characteristics (SPCs) for combined oral contraceptives (COCs) and progestogen-only pills (POPs) advise against use by women with a history of cholestatic jaundice or with severe pruritis in pregnancy. The World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use (WHOMEC) however recommends that for women with pregnancy-related cholestasis the benefits of COC use outweigh the risks (WHO Category 2) and progestogen-only methods or non-hormonal methods can be used without restriction (WHO Category 1). No evidence was identified to support an increased risk of recurrence of symptoms with hormonal contraceptive use. The CEU advises that women with a history of pregnancy-related cholestasis should be informed about the unknown risk of recurrence with hormonal contraceptive use. After counselling regarding non-hormonal methods women with a history of pregnancy-related cholestasis may choose to use hormonal methods (COCs POPs progestogen-only injectables implant or intrauterine system). Women should be informed that the use of COCs and POPs in this situation is outside the product licence. (excerpt)

Ovarian function with a novel combined contraceptive vaginal ring. Mulders TMT, Dieben TOM, Coelingh Bennick HJT. Hum Reprod 2002; 17: 2594-2599

This large study investigated the impact of oral contraceptive OC use on the time to conception in fertile women. The Avon Longitudinal Study of Parents and Children (ALSPAC) aims to define environmental and genetic factors, which may influence pregnancy outcome and the development and health of children. Couples were eligible for recruitment of the study if they had an expected date of delivery between 1 April 1991 and 31 December 1992. Almost 85% of couples eligible to take part were recruited. This was a prospective study of fertile couples for birth outcome but was retrospective in the identification of the time taken to conceive the index pregnancy. The couples completed questionnaires at 18 weeks’ gestation to try to avoid recall bias. Specific fertility factors were identified such as obstetric and gynaecological history; use of contraception; if the pregnancy was planned; and the length of time to conceive (less than 6 months up to over 3 years). Other information such as age, smoking, alcohol consumption and ethnic origin were also obtained. Logistic regression analyses identified factors associated with conception within 12 months and analyses were also performed separately for women who had never previously conceived. A total of 12 106 couples were eligible: 8497 had conceived intentionally, 3545 had conceived accidentally, and 64 did not answer the question. Most of those whose pregnancies were planned indicated the time it had taken to conceive. For these the proportions were as follows: 74.2% within the first 6 months; 13.9% within the second 6 months; 8.5% in Year 2 or 3; and 3.4% after Year 3. Interestingly, in women with planned pregnancies, an increasing duration of previous OC use was significantly associated with an increased proportion of conceptions in the first 6 months. Use of OC for over 5 years was used as the reference group [odds ratio (OR) 1.0] because of the small sample size of never or very shortterm users. Use of OC for less than 5 years was associated with an OR of conception in the first 12 months of 0.83 (95% CI 0.63–1.09); for never users OR 0.61 (95% CI 0.44–0.85). The type of OC used was not identified but is likely to be mainly the combined oral contraceptive (COC) (over 95% in 1991–1992). A number of suggestions have been proposed as to why this improvement in conception may be biologically plausible: improved iron stores due to reduction in the incidence of menorrhagia seen with the COC; perhaps a reduction in endometriosis; a lower rate of chromosomal abnormalities and age-related miscarriage associated with the COC. Findings from this large study of women in the South West of England may be reassuring for other British women using OC. It does not suggest a reduction in fertility with OC use regardless of duration of use. Among fertile women, prolonged use of OC is actually associated with a shorter time to conception. This association is strongest after 5 or more years’ use, is also the case for women who have never been pregnant, and is independent of other factors.

Prolonged use of oral contraception before a planned pregnancy is associated with a decreased risk of delayed conception. Farrow A, Hull MGR, Northstone K, et al. J Hum Reprod 2002; 17: 2754-2761

This large study investigated the impact of oral contraceptive OC use on the time to conception in fertile women. The Avon Longitudinal Study of Parents and Children (ALSPAC) aims to define environmental and genetic factors, which may influence pregnancy outcome and the development and health of children. Couples were eligible for recruitment of the study if they had an expected date of delivery between 1 April 1991 and 31 December 1992. Almost 85% of couples eligible to take part were recruited. This was a prospective study of fertile couples for birth outcome but was retrospective in the identification of the time taken to conceive the index pregnancy. The couples completed questionnaires at 18 weeks’ gestation to try to avoid recall bias. Specific fertility factors were identified such as obstetric and gynaecological history; use of contraception; if the pregnancy was planned; and the length of time to conceive (less than 6 months up to over 3 years). Other information such as age, smoking, alcohol consumption and ethnic origin were also obtained. Logistic regression analyses identified factors associated with conception within 12 months and analyses were also performed separately for women who had never previously conceived. A total of 12 106 couples were eligible: 8497 had conceived intentionally, 3545 had conceived accidentally, and 64 did not answer the question. Most of those whose pregnancies were planned indicated the time it had taken to conceive. For these the proportions were as follows: 74.2% within the first 6 months; 13.9% within the second 6 months; 8.5% in Year 2 or 3; and 3.4% after Year 3. Interestingly, in women with planned pregnancies, an increasing duration of previous OC use was significantly associated with an increased proportion of conceptions in the first 6 months. Use of OC for over 5 years was used as the reference group [odds ratio (OR) 1.0] because of the small sample size of never or very shortterm users. Use of OC for less than 5 years was associated with an OR of conception in the first 12 months of 0.83 (95% CI 0.63–1.09); for never users OR 0.61 (95% CI 0.44–0.85). The type of OC used was not identified but is likely to be mainly the combined oral contraceptive (COC) (over 95% in 1991–1992). A number of suggestions have been proposed as to why this improvement in conception may be biologically plausible: improved iron stores due to reduction in the incidence of menorrhagia seen with the COC; perhaps a reduction in endometriosis; a lower rate of chromosomal abnormalities and age-related miscarriage associated with the COC. Findings from this large study of women in the South West of England may be reassuring for other British women using OC. It does not suggest a reduction in fertility with OC use regardless of duration of use. Among fertile women, prolonged use of OC is actually associated with a shorter time to conception. This association is strongest after 5 or more years’ use, is also the case for women who have never been pregnant, and is independent of other factors.

Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence. Stanwood NL, Grimes DA, Schulz KF. Br J Obstet Gynaecol 2001; 108: 1168-1173

women discontinued due to problems with compliance to the study. Although women were not randomised, statistical tests showed both groups were similar with respect to demographic details of women and infants. The results indicated there was no significant difference in mean volume of milk produced between the two groups. Milk volume was measured as preand post-feed infant weight, over 24 hours as is the standard method of assessment. The composition of milk was similar in both groups in terms of triglyceride, protein and lactose content. It was calculated that the suckling infant received a maximum of 0.01–0.05 μg/kg/day desogestrel. This accounts for 2.6–3.7% of the daily maternal dose. No significant differences were noted in weight, length and biparietal diameter up to the seventh cycle of treatment. When infants were followed up at 18 and 30 months there were no clinically relevant differences between the two groups. The authors conclude that 75 μg desogestrel progestogen-only pill is a safe and effective method of contraception for lactating women. Efficacy cannot be concluded from the study as pregnancy rates were not reported, however the authors refer to the effectiveness of the desogestrel pill from published data where desogestrel is known to inhibit ovulation and has a 12-hour window for missed pills. Bias may have been introduced due to the nonrandomisation of women and also because neither patient nor researchers were blinded. It is unclear if laboratory staff were blinded. However, automated testing was used to identify milk composition. The safety of the desogestrel pill for lactating women has been demonstrated in this study.

Comparative study of the effects of a progestogen-only pill containing desogestrel and an intrauterine contraceptive device in lactating women. Bjarnadottir RI, Gottfredsdottir H, Sigurdardottir K, et al. Br J Obstet Gynaecol 2001; 108: 1174-1180

as age at first intercourse and age at first pregnancy. An association between increasing duration of OC use and risk of cervical cancer and carcinoma in situ was identified. No association was found with age at first OC use. Use of OC for less than 5 years was not associated with increased risk of cervical neoplasia. Women with a total of 5 to 9 years of OC use had almost three times the risk of cervical neoplasia (odds ratio 2.82, 95% CI 1.46–5.42). Those women with more than 10 years of OC use had four times the risk of cervical neoplasia (odds ratio 4.03, 95% CI 2.09–7.79). The increased risk of cervical neoplasia appeared to persist for as long as 15 years after discontinuing OC. Use of OC itself did not appear to increase the chance of infection with HPV. This study would appear to confirm a plausible association between OC and cervical cancer. Researchers focused on women deemed at high risk of developing cervical cancer because they were HPV-positive. These findings cannot therefore be explained away by higher risk sexual activity as has been done previously. It must be acknowledged, however, that there are a number of areas where bias may have been introduced. Recall bias is acknowledged in that women may not have accurately recalled previous use of hormonal contraceptive methods and some may have used progestogen-only methods. Only one HPV test was carried out, but persistence of HPV is thought to be an important factor in carcinogenesis. This study therefore could not distinguish those women who had only transient infection from those with persistent HPV. Although the findings are relevant for women in the developed world, most of the women in the study (apart from those from Spain) lived in countries in which there are no national cervical screening programmes. This study serves to underline the importance of attending for regular cervical screening smears. In this context, these findings need not affect women’s contraceptive or reproductive choices. In discussion with women in the UK, it is important to stress the much lower rates of cervical cancer here, in addition to the many benefits of OC use and attending for routine cervical screening.