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Australian women face compliance, availability, and cost problems with contraceptives. In reality, oral contraceptives (OCs) have a high failure rate. An abortion survey in New South Wales in 1992 found that 14.4% of women were using OCs at the time of conception. Complete compliance with OCs is uncommon (28-40%). Abrupt cessation of OC use and forgetting to use pills at either end of the pill cycle are major reasons for noncompliance. Leading reasons for abrupt cessation of OCs are concerns about OCs, poor cycle control, weight gain, and headaches. Some ways to improve OC compliance are improved packaging, uniform missed pill instructions, clearer and more readable package inserts, improved verbal and written counseling, and detailed instructions on how to take the pills and what to do when one misses a pill. The abortion survey found that 22% of women seeking an abortion were using condoms at the time of conception. Many report a broken or slipped condom, both of which are generally caused by incorrect usage. Women who use the diaphragm only when they have intercourse have a higher failure rate than those who keep it in place for 24 hours, even though the latter do not use spermicides. Women are less likely to use their contraceptive method if the instructions are difficult and complicated. The vaginal ring has potential because it does not require action every day and can be left in place. The mass media and attitudes of providers influence women's choice of contraceptives. In New South Wales, only 50% of general practitioners discuss IUDs when they talk to women about contraception. 11% of women in the abortion survey could not obtain postcoital contraception from their physicians. A postcoital contraceptive and low dose OCs should be readily available in Australia. Contraceptives are expensive in Australia. Some contraceptives which are unavailable in Australia are OCs with gestodene, postcoital contraceptives, the levonorgestrel-releasing IUD, Norplant, the vaginal sponge, the female condom, and RU-486.
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PMID:Practical problems which women encounter with available contraception in Australia. 784 7

This study attempted to quantify an achievable removal rate of subdermal levonorgestrel implants (SLIs) in an unselected population and develop strategies for increasing continuation. Over 16 months, 1,076 SLIs were inserted in eligible patients from a lower socioeconomic group at high risk for unintended pregnancy. Extensive preinsertion and postinsertion counseling and follow-up care were given. Patients developing problems were counseled and managed conservatively. If a patient requested removal of the Norplant after this process, removal was done. Twenty-two removals occurred due to SLI-related problems, for a rate of 2.04%; no trends based on age or parity were found. The most common reasons for removal were bleeding/irregular menses (31.8%), headaches (18.1%) and hair loss (13.6%). An episode of thrombophlebitis, not thought to be caused by the SLI, led to one removal. Seventy-seven percent of removals occurred in the first six months, with peak rates in the fourth and fifth. Five patients became pregnant inadvertently within six months of removal. An extremely low removal rate and high continuation rate are possible in an inner city clinic population at risk for unintended pregnancy. Acceptance will increase if the SLI can be maintained at least past six months. Extensive counseling, patient support and conservative medical management constitute a successful approach.
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PMID:Removal rates of subdermal levonorgestrel implants. 785 77

An analysis is provided of 208 women who accepted Norplant between March 1991 and July 1992 at Columbia Presbyterian Medical Center in New York City. About 9600 patients attended the family planning clinics during the study period. The findings indicated that 45% of Norplant users were insured by Medicaid, 52% were not charged, and 3% paid in full or partially. The waiting list for Norplant was 400 persons long due to budget constraints and limited product availability. There were 353 visits among 170 Norplant users by October 20, 1993, of which 25% took place within the first month following insertion. The mean follow-up time after insertion was 10.8 months for 208 patients and 11.9 months for those with any follow-up visit. Follow-ups visits were similar for teenagers and adults. 64 women returned for removal by October 20, 1993. The mean duration of use before removal was 12.1 months. The reasons for removal were given as irregular bleeding, weight gain, and headache. The mean age of those with implants removed was 26.1 years. 19.0% of Norplant acceptors were teenagers, of whom 64.0% were discontinuers. One ectopic pregnancy occurred at 24 months, and one intrauterine pregnancy occurred at 14 months. The ectopic pregnancy did not require surgery. 163 users had a contraceptive history. 93% had used oral contraceptives, and 56% had discontinued use due to side effects. The mean duration of implant use was 19.9 months distributed as follows: 45 women for 16 months, 89 women for 16-23 months, 35 women at 23-28 months, and 39 women after 28 months. The removal rate was 19/100 woman years. Teenage removal rate was 2.7/100 woman years. The first 12 months removal rate among 179 women was 15/100 woman years. The two-year removal rate was 32/100 woman years. The return visit rate was considered low, and acceptance was considered high among a Hispanic population; continuation was high among teenagers.
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PMID:Use of Norplant implants in a New York City clinic population. 807 Feb 60

Between October 1986 and November 1988, physicians enrolled 267 20-41 year old women in a clinical trial of Norplant-2 (2 Silastic rods with 70 mg levonorgestrel each) at the National Taiwan University Hospital to evaluate the advantages and side effects of Norplant-2. 36 women were lost to follow up. 63% suffered from menstrual problems during the first 3 months. 73.6% of these women still had menstrual problems at 6 months. 6 women then chose to discontinue using Norplant-2. 51.8% of the remaining women had persistent menstrual problems at 1 year. 62% of women who discontinued Norplant-2 before the end of 3 years discontinued it due to menstrual problems. The continuation rate was 84.5% at 1 year, 61.3% at 2 years, and 52% at 3 years. 78.6% of women who discontinued Norplant-2 to become pregnant conceived within 1 year after its removal. Just 1 woman (.04%) became pregnant while using Norplant-2. She was thin and smoked heavily. Her aborted fetus had an abnormal fetus had an abnormal karyotype (47,XY,+22). The mean serum total cholesterol and triglyceride levels dropped considerably after Norplant-2 implantation from 164 to 147 mg/dl and from 81 to 63 mg/dl at 12 months, respectively; p .05). Mean hemoglobin levels increased from 12.6 g/dl to 13 g/dl at 12 months (p .05). Levonorgestrel did not affect liver or renal functions. Mean body weight and blood pressure remained the same. Observed psychophysiologic symptoms included depression, acne, headaches, nervousness, and insomnia. These findings indicated Norplant-2 to be safe, reversible, long-acting, and very effective, therefore the family planning program in Taiwan should add it to its contraceptive menu.
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PMID:Norplant-2 subdermal contraceptive system: experience in Taiwan. 810 98

Women who received Norplant contraceptive implants from any of fifteen clinical settings in southeast Texas, U.S.A., were followed for one year to determine their reactions to the method. Of 1,385 who enrolled to receive Norplant implants, 1,253 had implants inserted. Side effects were reported by 78% of those receiving implants and 70% described changes in bleeding patterns. Spotting or irregular bleeding, weight gain and headaches were the conditions reported most frequently. Nine pregnancies were reported during the study period. Six of these, however, existed before the implants were inserted. At the one year anniversary, 143 of women receiving implants had had them removed. Those who discontinued method use were less satisfied, reported more side effects and were more likely to have planned to have another child, thus using the method for spacing, or to have had a change in their marital status while they were using the contraceptive. Providers should counsel patients to focus attention on plans for the future in selecting their contraceptive method. In addition, we recommend, as does the product's distributor, that providers confirm that patients are not pregnant prior to inserting implants.
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PMID:One-year experience with subdermal contraceptive implants in the United States. 822 53

Between August 1991 and April 1993, in Texas, family planning specialists analyzed prospective data on 2358 women who underwent Norplant system insertions at either the Division of Maternal Health and Family Planning clinics of the University of Texas Southwestern Medical Center or at Parkland Memorial Hospital. The household income of about 90% of the women was at or below the poverty level. Health workers counseled each woman expressing interest in Norplant individually so the women understood the risks, benefits, and side effects. The women had access to health workers via telephone, clinic appointment, or clinic walk-in visits when they had questions and concerns. At the time of insertion, 43% of the women were no older than 19 years of age. 14% were 16-years-old or younger. 63% of the 431 women who received Norplant immediately after delivery were no more than 19-years-old. 74% of all the women had at least one concern about Norplant. The leading concern was pain at the time of insertion (32.1%) followed by weight changes (14.8%), and menstrual changes (12.2%). As of August 1993, only 138 (5.85%) of the women requested removal (adolescents = 40%). The reasons for removal included irregular bleeding (41.3%), headache (22.5%), pain in the arm with Norplant (18.1%), weight gain (14.5%), hair loss (10.1%), mood changes (8%), and desire for pregnancy (8%). The researchers had not anticipated the high incidence rates of arm pain, hair loss, and mood changes. These findings suggested that Norplant is an acceptable longterm contraceptive method. Other studies showed that it is also very effective.
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PMID:A preliminary report of Norplant implant insertions in a large urban family planning program. 822 63

Researchers compared the efficacy, safety, and acceptability of a triphasic oral contraceptive (OC), Triquilar, with those of a monophasic OC, Lo-Femenal, among 1088 women attending clinics in Chile, the Dominican Republic, Ecuador, Sri Lanka, and the Sudan. Both OCs contained levonorgestrel and ethinyl estradiol. 90% of women in each group exhibited good user compliance. Only 1 unplanned pregnancy occurred in each group, and both pregnancies were attributed to user failure. The gross cumulative efficacy rates at 11 months were 0.3/100 woman-years for the triphasic OC and 0.2/100 woman-years for the monophasic OC. The continuation rate at 11 months was lower for Lo-Femenal than it was for Triquilar (80.8% vs. 84.6%), but the difference was not significant. The leading side-effect-related reason for discontinuation in both groups was headache. Another key reason for OC discontinuation in both groups was personal reasons, such as planning a pregnancy. Most women in both groups did not have menstrual complaints (78.8% for the Triquilar group and 77.1% for the Lo-Femenal group). Intermenstrual bleeding rates were low (7.6% for the Triquilar group and 9% for the Lo-Femenal group). Significant intercenter differences for women reporting intermenstrual bleeding and side effects (e.g., headaches) existed (p .05). Women from both groups at the clinic in the Sudan always had lower reports of intermenstrual bleeding than those at the other clinics. In fact, no woman discontinued OC use because of intermenstrual bleeding in the Sudan. Women in Sri Lanka reported fewer side effects than those in other countries, suggesting they could better tolerate OCs than the other women. This multicenter study's findings indicates that both Triquilar and Lo-Femenal are effective and safe. In addition, they exhibit good cycle control.
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PMID:A multicenter comparative trial of triphasic and monophasic, low-dose combined oral contraceptives. 833 88

From February 1985 to February 1986, researchers enrolled 600 18-40 year old women at the Dhaka Medical College and Hospital, the Institute of Postgraduate Medicine and Research, and the Mohammadpur Fertility Services and Training Centre in a 5-year clinical trial to evaluate the contraceptive efficacy, safety, and acceptability of Norplant subdermal implants in Bangladesh. They scheduled the women to return for follow-up visits 1, 3, and 6 months after insertion and every 6 months thereafter until removal or at the end of 5 years. No pregnancies after insertion occurred during the study. The gross cumulative continuation rate was 93.9% at 1 year and 72.3% at 2 years. The 5-year cumulative continuation rate was 41.2% which was much lower than that in other Asian countries (e.g., 52.3% in Sri Lanka and 78.2% in Indonesia). The 5-year cumulative discontinuation rate for menstrual problems was 30.7% which was higher than that of other studies. It may have been higher because Bangladeshi women do not tolerate well and accept changes in bleeding patterns, especially since menstrual bleeding prevents them from prayer and taking part in sexual activity. 45.3% of all women requesting early Norplant removal complained of menstrual problems, especially prolonged heavy bleeding (75% of women requesting removal for menstrual problems). Most menstrual problem removals took place during the 2nd year and fell thereafter. Desired pregnancy was the second most common reason for removal (18.6%). The gross discontinuation rate for nonmenstrual side effects was just 2.2%, the main side effect being headaches. 97.5% of women who completed the 5-year study considered their experience with Norplant favorable. The leading reason for a favorable rating for Norplant was its duration of use (64.5%). Menstrual changes comprised the least favorable component of Norplant among women who completed the study (63.3%). 33% of women still wanting to use contraception after 5 years of Norplant use said they would use Norplant again.
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PMID:A five-year clinical evaluation of Norplant contraceptive subdermal implants in Bangladeshi acceptors. 833 91

Between April and October 1991 in Baltimore, Maryland, family planning providers tried to follow 246 13-42 year old women at a clinic at the Francis Scott Key (FSK) Medical Center for 3 months who accepted the levonorgestrel-releasing implant Norplant to evaluate its acceptability and effectiveness among a high-risk population. 56% of the women were Black and 41% White. 69% were single. Most were interval gynecologic patients (109), but many were postabortion patients (97). The providers could only follow 108 women. Reasons for unscheduled visits were insertion site tenderness, amenorrhea, and removal. At 1 month, 70 % had at least 1 side effect. 48% had irregular bleeding 1-2 months after insertion. Other side effects included headache (49%), acne (24%), weight gain (22%), increased appetite (19%), and dizziness (18.5%). The 24-hour telephone hotline had only received 38 problem calls, all of which were from FSK Norplant patients. More than 50% of the calls were about menstruation concerns. Reasons for removal included pressure to receive Norplant, increased acne, headaches and prolonged bleeding, and postinsertion site problems. 1 woman became pregnant, but it occurred before insertion. She underwent an abortion and continued to use Norplant. 78% of the women considered Norplant to be excellent and 14% considered it to be good. 95% would recommend it to others. 69% reported convenience to be the best thing about Norplant and 22% said it was pregnancy prevention. Worst things were irregular bleeding (26%) and progestin-related side effects (e.g., headaches and weight gain) (19%). 35% did not consider anything to be bad about Norplant. 64% had at least some apprehension before insertion, the major reasons being fear of needles (48%) and of pain (37%). Prior to insertion, just 37% were worried about potential side effects. The providers thought that the routine follow-up visit at 1 month was not cost-effective and provided no specific clinical benefit. They advocated adequate counseling about side effects to take the place of the follow-up visit.
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PMID:Preliminary experience with Norplant in an inner city population. 844 19

The US Food and Drug Administration approved the contraceptive implant system, Norplant, in February 1990. It has been used in other countries for more than 15 years before the US approved it. The 6 subdermally placed capsules in the upper inner arm release 50-80 mcg levonorgestrel/day into the bloodstream, resulting in a 99.8% efficacy rate. Patient education and counseling, especially about changes in the bleeding pattern and Norplant's inability to protect against sexually transmitted diseases, are important to maintain client satisfaction and continued use of Norplant. Side effects, from most to least common, are changes in menstrual bleeding, constant bleeding, missed periods, weight gain/increased appetite, headache, oily skin or acne, weight loss/nausea, breast tenderness, nervousness or loss of appetite, and hair loss. It is rare when complications are so severe that they require removal of the implants. Contraindications to Norplant include active liver disease, active thromboembolic disease, breast cancer, pregnancy, and undiagnosed dysfunctional uterine bleeding. Antiepileptic medications, barbiturates, treatment for tuberculosis, and Butazolidin/phenylbutazone reduce Norplant's efficacy. A trained person should insert Norplant within the first 5-7 days of the menstrual cycle when it is evident there is no pregnancy. Some reports recommend that, after childbirth, it should be inserted 6 weeks postpartum to avoid hemorrhage. Yet, nurse-midwives at the Center for Addiction and Pregnancy at the Francis Scott Key Medical Center in Baltimore, Maryland, insert Norplant 24-48 hours postpartum in non-breast-feeding mothers with no increase in hemorrhage. Norplant must be removed no longer than 5 years after insertion. Certified nurse-midwives wanting to incorporate Norplant into their practices should follow the Guidelines for the Incorporation of New Procedures into Nurse-Midwifery Practice and have available a consulting physician who is familiar with and skilled in inserting Norplant. The manufacturer conducts training sessions for health professionals.
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PMID:Subdermal contraceptive implants in nurse-midwifery practice. 848 13


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