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Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-feeding patterns.

OBJECTIVE: The purpose of this study was to identify the impact on breast-feeding patterns of early postpartum initiation of progestin-only birth control methods compared with nonhormonal methods. STUDY DESIGN: A prospective, nonrandomized trial was performed comparing progestin-only contraceptive methods administered before hospital discharge with nonhormonal methods on breast-feeding continuation rates, exclusive breast-feeding, and supplementation at 2, 4, and 6 weeks after delivery. RESULTS: Three hundred nineteen women provided complete data until hospital discharge. The hormonal group had higher risk factors for not breast-feeding, but there was no difference among any of the subgroups in breast-feeding continuation rates except at week 4. Supplementation or perception of insufficient milk production did not differ between groups. By week 6, 23.5% of women discontinued breast-feeding, and 64.5% of those breast-feeding were supplementing. CONCLUSION: This study demonstrates that there is no detectable adverse impact on breast-feeding attributable to progestin-only contraceptive methods initiated within the first 3 days post partum.

Breast Feeding↗

Hormonally impregnated intrauterine systems (IUSs) versus other forms of reversible contraceptives as effective methods of preventing pregnancy.

BACKGROUND: In the 1970s a new approach to the delivery of hormonal contraception was researched and developed. It was suggested that the addition of a progestogen to a non-medicated contraceptive device improved its contraceptive action. An advantage of these hormonally impregnated intrauterine systems (IUS) is that they are relatively maintenance free, with users having to consciously discontinue using them to become pregnant rather than taking a proactive daily decision to avoid conception. OBJECTIVES: To assess the contraceptive efficacy, tolerability and acceptability of hormonally impregnated intrauterine systems (IUSs) in comparison to other reversible contraceptive methods. SEARCH STRATEGY: Literature was identified through database searches, reference lists and individuals/organisations working in the field. Searches covered the period from 1972 to November 2003. SELECTION CRITERIA: All randomised controlled trials comparing IUSs with other forms of reversible contraceptives and reporting on pre-determined outcomes in women of reproductive years. The primary outcomes were pregnancy due to method/user failure and continuation rate. DATA COLLECTION AND ANALYSIS: The quality assessment of studies and data extraction were completed independently by two blinded reviewers. A quality checklist was designed to identify general methodological and contraceptive specific factors which could bias results. Events per women months and single decrement life table rates were extracted where possible for pregnancy, continuation, adverse events and reasons for discontinuation. Events per total number of women at follow up were collected for hormonal side effects and menstrual disturbance. When appropriate, data were pooled at the same points of follow up to calculate rate ratios in order to determine the relative effectiveness of one method compared to another. For the single decrement life table rates, the rate differences were pooled to determine the absolute difference in effectiveness of one method compared to another. Interventions were only combined if the contraceptive methods were similar. Non-hormonal IUDs were divided into three categories for the purpose of comparison with IUSs: IUDs >250mm2 (i.e. CuT 380A IUD and CuT 380 Ag IUD), IUDs <=250mm2 (i.e. Nova-T, Multiload, CuT 200 and CuT 220 IUDs) and non-medicated IUDs. MAIN RESULTS: Twenty-one RCTs comparing hormonally impregnated IUSs to a reversible contraceptive method met the inclusion criteria and it was possible to include eight of these in the meta-analyses, four comparing LNG-20 IUSs with non-hormonal IUDs, one comparing the LNG-20 IUS with Norplant-2 and three comparing Progestasert with non-hormonal IUDs. No significant difference was observed between the pregnancy rates for the LNG-20 users and those for the IUD >250mm2 users. However, women using the LNG-20 IUS were significantly less likely to become pregnant than those using the IUD <=250mm2. Women using the LNG-20 IUS were more likely to experience amenorrhoea and device expulsion than women using IUDs >250mm2. LNG-20 users were significantly more likely than all the IUD users to discontinue because of hormonal side effects and menstrual disturbance, which on further breakdown of the data was due to amenorrhoea. When the LNG-20 IUS was compared to Norplant-2, the LNG-20 users were significantly more likely to experience amenorrhoea and oligomenorrhoea, but significantly less likely to experience prolonged bleeding and spotting. No other significant differences were observed. Progestasert users were significantly less likely to become pregnant and less likely to continue on the method than non-medicated IUD users after one year, but no significant difference was noted for these two outcomes when Progestasert users were compared to IUD<=250mm2 users. The only other significant differences found in the meta-analyses were that Progestasert users were less likely to expel the device and more likely to discontinue the method because of menstrual bleeding and pain than users of IUDs <=250mm2. REVIEWERS' CONCLUSIONl the device and more likely to discontinue the method because of menstrual bleeding and pain than users of IUDs <=250mm2. REVIEWERS' CONCLUSIONS: Current evidence suggests LNG-20 IUS users are no more or less likely to have unwanted pregnancies than IUD >250mm2 and Norplant-2 users. The LNG-20 IUS was more effective in preventing either intrauterine or extrauterine pregnancies than IUDs <=250mm2. The contraceptive effectiveness of Progestasert was significantly better than non-medicated IUDs, but no difference was observed when compared to IUDs<=250mm2. Continuation of LNG-20 IUS use was similar to continuation of the non-hormonal IUDs and Norplant-2. Amenorrhoea was the main reason for the discontinuation for the LNG-20 IUS and women should be informed of this prior to starting this method.

Contraceptive Agents, Female↗

Once a month administration of mifepristone improves bleeding patterns in women using subdermal contraceptive implants releasing levonorgestrel.

It has been suggested that the administration of an anti-progesterone might improve bleeding patterns in women with irregular bleeding while using low-dose progestin-only contraception. We report the findings of a double-blind, randomized, placebo-controlled trial of mifepristone 50 mg taken once every 4 weeks in 100 Chinese women (50 subjects and 50 controls) complaining of frequent and irregular bleeding while using a levonorgestrel-releasing subdermal contraceptive implant. In all women, regardless of treatment, the frequency of bleeding decreased significantly over 360 days of observation. Women recorded significantly shorter episodes of bleeding (P: < 0.0002) during mifepristone treatment than during the 90 days before treatment started. In contrast, the duration of bleeding episodes fell more gradually in placebo-treated controls. Women using mifepristone were more likely to find treatment acceptable than women receiving a placebo tablet (P: < 0.01). Despite concern that anti-progestogenic effects may jeopardize contraception, there were no pregnancies. This approach may offer a useful strategy to improve continuation rates by alleviating unwanted side-effects until bleeding patterns improve spontaneously with time.

Adolescent↗

Mortality among oral-contraceptive users. Royal College of General Practitioners' Oral Contraception Study.

In a large prospective study carried out in the United Kingdom, the death-rate from diseases of the circulatory system in women who had used oral contraceptives was five times that of controls who had never used them; and the death-rate in those who had taken the pill continuously for 5 years or more was ten times that of the controls. The excess deaths in oral-contraceptive users were due to a wide range of vascular conditions. The total mortality-rate in women who had ever used the pill was increased by 40%, and this was due to an increase in deaths from circulatory diseases of 1 per 5000 ever-users per year. The excess was substantially greater than the death-rate from complications of pregnancy in the controls, and was double the death-rate from accidents. The excess mortality-rate increased with age, cigarette smoking, and duration of oral contraceptive use.

Adolescent↗

Public funding of contraceptive, sterilization and abortion services, 1982.

The federal government and the states spent $328 million to support the provision of contraceptive services in fiscal 1982, 13 percent less than they had spent the previous year. Federal funds for family planning services came from Title X of the Public Health Service Act, Title XIX of the Social Security Act (Medicaid), and the Maternal and Child Health (MCH) and Social Services block grants, which are administered by the states. Title X continued to provide the largest, although a diminishing, share of public funds for contraceptive services--36 percent of all such funds in 1982. (In 1980, Title X had accounted for 44 percent of public funding.) Medicaid expenditures for family planning totaled $94 million; $17 million was spent under the MCH block grant, and $46 million under the Social Services block grant. State governments contributed an additional $53 million, about the same figure reported for the previous year, indicating that the states did not use their own funds to soften the impact of cuts in federal expenditures for contraceptive services in 1982. The federal government and the states spent an estimated $55 million, almost all of it through Medicaid, to provide sterilization services for poor women. The states spent $67 million and the federal government spent $1 million to provide abortions for 210,000 indigent women. These figures come from the 11th annual survey of state health and welfare agencies and state Medicaid programs by The Alan Guttmacher Institute (AGI). The AGI conducted this survey in January 1983 to determine the levels and sources of public funding for contraceptive, sterilization and abortion services in each state during FY 1982.

Abortion, Legal↗

Use of a progestogen only preparation containing desogestrel in the treatment of recurrent pelvic pain after conservative surgery for endometriosis.

OBJECTIVE: To assess the effect of a new progestin progestogen only pill (desogestrel) versus an oral contraceptive in the treatment of recurrent endometriosis. STUDY DESIGN: A randomized prospective clinical study. A group of women with endometriosis (n=40) who showed recurrent dysmenorrhea and/or pelvic pain after conservative surgery, and did not desire a pregnancy. Continuous treatment for 6 months with desogestrel (75 microg/d) (n=20) versus a combined oral contraceptive (ethinyl estradiol 20 microg plus desogestrel 150 microg) (n=20) was performed. RESULTS: A significant improvement of both pelvic pain and dysmenorrhea was observed following each type of treatment (P<0.001). The use of desogestrel progestogen only pill was associated with a breakthrough bleeding in 20% patients, while a significant body weight increase was observed in 15% after oral contraceptive. CONCLUSIONS: Both desogestrel and an oral estro-progestinic were effective, safe and low cost therapy of pain symptoms after endoscopic surgery for endometriosis, the former showing an impact on breakthrough bleeding, the later an incidence on body weight increase.

Adult↗

Oral contraceptives: significance of their effects in man and relationship to findings in animal models.

Combination oral contraceptives have been available since 1960. They contain both an estrogen and a progestogen and have been studied extensively in both lower animals and humans and have been the subject of special regulatory requirements for toxicological and clinical studies. The initial oral contraceptives, by today's standards, contained very high levels of both hormones. There has been a continuous decrease in the dose of both the estrogen and the progestogen during the past quarter century, with continued maintenance of high degree of effectiveness. This decrease of dosage has been stimulated by findings from prospective clinical trials and retrospective case control trials. As additional information has been gained with oral contraceptives, new benefits beyond their effectiveness as contraceptives have been realized. Today's oral contraceptives provide a high degree of effectiveness, low incidence of nuisance side effects, and low incidence of major adverse effects.

Animals↗

Clinical performance of the Nova-T380 IUD in routine use by the UK Family Planning and Reproductive Health Research Network: 12-month report.

Doctors working in general practice and at family planning clinics throughout the UK who collaborate in the UK Family Planning and Reproductive Health Research Network were responsible for the fitting of 572 Nova-T380 intra-uterine contraceptive devices (IUDs). The Nova-T (and formerly the identical Novagard) IUDs have copper with a surface area of 200 mm(2). The device used in this study, the Nova-T380, has copper with a surface area of 380 mm(2). The purpose of the study was to evaluate the pregnancy and complication rates of this new device, with its increased area of copper, in comparison with other published results, in the clinical setting of British general practice and family planning clinics. The 12-month cumulative life-table event rates were: pregnancy 0.8, expulsion 5.6, removal for bleeding or bleeding and pain 11.0. The continuation rate was 73.4. The pregnancy rate at 12 months showed good contraceptive performance. The increased surface area of copper was not associated with a reduced pregnancy rate, but as this was not a direct comparative study with the Nova-T, the influence of the increased area of copper must remain somewhat uncertain. This study found the discontinuation rate for bleeding problems and pain with bleeding to be higher than in other published studies. Other event rates were consistent with other published studies.

Adolescent↗

Vaginal rings for contraception in lactating women.

Contraceptive methods for breastfeeding women should be safe for the mother and infant and should not interfere with lactation. Progestin-only methods meet these conditions and can be used from the sixth week postpartum. Because all progestins are excreted in milk, those that are insufficiently active by the oral route are preferable to avoid any possible effect on the baby. These steroids, however, must be administered to the mother by a non-oral route. Initially, progesterone was administered subdermally to test this concept. Subsequently, a progesterone vaginal ring was developed to be used continuously for 3 to 4 months and replaced with a new device, as needed, until weaning. Clinical trials have shown a high contraceptive efficacy (over 98.5%) and safety. The gross continuation rate of this method is approximately 40% at 12 months of use, with use-related problems being the main reason for discontinuation (26.8%). Currently, a Nestorone vaginal ring is under development, delivering 50 microg of Nestorone per day. It may be used continuously for up to one year, even if weaning occurs earlier. Both of these progestin-only rings prolong lactational amenorrhea to 10 to 12 months, which represents a health benefit and convenience for many women. The registration of the progesterone vaginal ring, developed as a contraceptive method to be used exclusively during lactation, has been approved in Chile and Perú. The fact that it is a user-controlled long-term contraceptive that delivers a natural hormone makes it an attractive option for many women.

Administration, Intravaginal↗

A multicentered clinical trial of the long-acting injectable contraceptive Depo Provera in Chinese women.

This study was an open trial where 1994 subjects each received Depo Provera injectable contraceptive every three months for one year and were observed a total of 20,294.3 woman months. At the time of observation, only one accidental pregnancy had occurred giving a use-effectiveness rate of 99.94% and a cumulative continuation rate of 72.87%. There were no significant adverse effects on weight and blood pressure. The main side effects were spotting, prolonged bleeding, and amenorrhea and these were also the main reasons of discontinuation. Complaints related to bleeding problems gradually decreased and complaints of amenorrhea increased with continued use. In lactating women, side effects occurrence rate was lower and continuation rate was higher in comparison with non-lactating women. Users did not report any effect on milk secretion. The results of this study confirm that Depo Provera is a very effective contraceptive method. With appropriate counseling and medical support, high acceptability and continuation rate can be achieved. Depo Provera is especially suitable for lactating women and could become a popular contraceptive method for lactating Chinese women.

Adolescent↗

Heterogeneity of sperm density profiles following 16-week therapy with continuous infusion of high-dose LHRH analog plus testosterone.

LHRH agonist analogs have been investigated as potential male contraceptives. It has been shown that the LHRH agonistic analog [D-Trp6,Pro9-NEt] LHRH (LHRHA) given to men in single doses up to 500 micrograms daily for up to 20 weeks with the coadministration of testosterone enanthate produces reversible oligozoospermia. Individual responses to the treatment, however, were variable. In this study, we gave the same analog to eight normal male volunteers as a continuous infusion of 500 micrograms daily for 16 weeks. Testosterone enanthate, 100 mg, was given by injection every second week. Six of the subjects became oligozoospermic but the other two retained sperm counts that were greater than 20 million/ml, although their treatment continued for 20 weeks. The reasons for this variability of response are not clear. Serum immunoreactive LH values increased during the infusion period whereas testosterone declined. FSH values fell during treatment in all subjects except the two non-responders. The acute pituitary response to LHRHA during the treatment or shortly thereafter (48 h) was completely abolished, and bioactive LH values were suppressed totally. FSH, LH, testosterone and sperm counts returned to normal in all subjects following discontinuation of LHRHA infusion. Continuous infusion of 500 micrograms of LHRHA daily for 16 weeks with 100 mg of testosterone enanthate every 2 weeks induced desensitization of the pituitary, loss of LH bioactivity, and decreases of FSH and testosterone. This mode of administration, however, did not improve sperm density results obtained earlier by single daily injections of the analog. Heterogeneity of sperm density profiles still persists for reasons that are not yet clear.

Adult↗

Depressive symptoms and Norplant contraceptive implants.

Women enrolled in a multicenter prospective study were evaluated to identify any possible relationship between depressive symptoms and the use of contraceptive implants. Women choosing Norplant implants (n = 910) were evaluated before starting this contraceptive and were reinterviewed at 6 months and 2 years. Women who continued the method had lower depressive symptom scores before initiating Norplant implants than did the women who discontinued the method or who were lost to follow up. Among the continuing Norplant implant users, the mean scores were similar before starting Norplant and at 6 months (7.9 vs 7.7). The strongest overall predictor of the depressive symptom score was relationship satisfaction. At 24 months, the subgroup of continuing users with decreased relationship satisfaction had an increase in depressive symptom score, but those with stable or improved relationships had stable depressive symptom scores. The subjects with the highest (i.e., worst) scores at enrollment demonstrated improved scores during follow-up. These results are reassuring for women who are concerned that Norplant use may adversely affect their mood.

Adolescent↗

Risk factors for benign breast disease.

The importance of various risk factors for benign breast disorders has been assessed an analysis of data obtained from a multicenter cohort study of contraceptive use among women in the United Kingdom (the Oxford Family Planning Association Contraceptive Study). Cases comprised all women diagnosed as having any type of benign breast lesion; 74 had fibroadenoma, 211 had histologically confirmed chronic cystic disease, 331 had breast lumps not subjected to biopsy and 70 had other disease. Each case was individually matched with another study participant who was free from recognized breast disease. Matching factors were center of recruitment, date of recruitment, age at entry, and continuation in the study. An inverse association was found between use of oral contraceptives and the risk of the first three conditions. Current users of the pill had the lowest risk, particularly when the use was for an extended period. In contrast, past users demonstrated no reduction in risk. The reduction in risk for chronic cystic disease appeared to relate to the amount of progestogen contained in the pill. No significant association was observed between the risk of any of the conditions and either parity or age at first livebirth. Women of low social class and obese women were at low risk, perhaps reflecting diagnostic biases.

Adult↗

[Condom: its role in the prevention of AIDS].

Since no effective vaccination is available, protection is our only arm against the spread of the human immunodeficiency virus. For public health officials and associations working against the spread of AIDS, the contraceptive is the ultimate arm and only generalized use will change the course of the pandemia. But because the disease continues to advance regularly it would appear necessary to have a second look at the official position. Actually, there are two sides to the contraceptive picture: 1. a real factor of protection for the healthy man who uses it, 2. a source of possible contamination of a healthy partner by a seropositive man who uses the contraceptive. The user cannot put the contraceptive on without touching his sexual organs which have been humidified by the pre-ejaculatory secretions which are rich in HIV and which are secreted long before complete erection allows him to install the contraceptive correctly. The result is that the inside surface of the contraceptive will always be more or less contaminated. There is therefore a major risk of contamination in certain situations, particularly for the virgin woman, before her first sexual intercourse, since an open wound is created by the rupture of the hymen. If we truly expect to eradicate this disease, the message will have to be changed.

Acquired Immunodeficiency Syndrome↗

Use of long-acting depot progestogen in domililiary family planning.

Medroxyprogesterone acetate injections have been used as a long-term contraceptive by the domiciliary family planning service in Glasgow. The injections were particularly useful in women with a high risk of becoming pregnant and in whom oral or intrauterine contraception had failed or was unacceptable. The optimum dose was 200 mg every 15-16 weeks. It was accepted by an increasing proportion of women, only 12 out of 162 discontinuing because of side effects. Continuation rates compared favourably with those for the pill, but less well than those for intrauterine contraceptive devices. The theoretical hazards should be weighed against the positive good resulting from controlled fertility in domiciliary patients.

Adolescent↗