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User compliance is not a problem for the recently approved subdermal, longterm contraceptive delivery system, Norplant. It delivers 50-80 mcg of levonorgestrel/day during the 1st year and 30-35 mcg for years 2-5. The levonorgestrel is encased in 6 36 mm x 2.4 mm capsules which are placed in the upper arm in 5-10 minutes using local anesthesia. Since the implants systemically release levonorgestrel, the shock to the liver experienced in oral contraceptive (OC) users does not occur. Levonorgestrel prevents pregnancy by decreasing luteinizing hormone and follicle stimulating hormone which prevents ovulation, reducing the rate of ovum transfer in the tube, making the endometrium incompatible for implantation, and making the cervical mucus too thick and scanty for sperms to migrate if ovulation does occur. 1-year pregnancy rates for Norplant users are much lower than for women who use other contraceptives (0.6/100 users vs. 2.3/100 for OC users and 2.4/100 for IUD users). The ectopic pregnancy rate is also low (1.47/1000 Norplant users). The 1-year continuation rate is 80% compared with 50% for OC users. Fertility returns within 3 months for 50% of users and within 1 year for 80%. Because Norplant does not adversely affect lipid metabolism there is no increase in the risk of atherogenesis. Menstrual irregularities are the leading side effect of Norplant. The irregular cycles tend to occur during the 1st 3-6 months after insertion. Other side effects include headaches, acne, breast discharge, weight gain, and transient ovarian cysts. Contraindications are abnormal uterine bleeding, possible pregnancy, active liver disease, and women taking phenytoin. The cost for the initial exam and insertion of the Norplant capsules is $500 at Planned parenthood of the Rocky Mountains in Colorado (mean=$8.30/month vs. $13/month for 5 years of taking OCs). Due to the possibility of exploitation of women and involuntary infertility, nurse practitioners must thoroughly explain the system to each patient and answer all questions so the patient can give informed consent.
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PMID:New concepts in contraception: Norplant subdermal implant. 156 6

The Norplant implant is described: the release rates and serum levels of levonorgestrel, the mode of action, the indications and contraindications, the effectiveness, incidence of ectopic pregnancy related to Norplant use, metabolic effects, advantages and disadvantages, insertion, the role of counseling, and management of side effects (menstrual bleeding changes, headache, weight changes, mastalgia, and acne), continuation rates and reasons for termination, and removal. Norplant is currently the most effective method of contraception. Counseling is important in order to provide women with as much information for informed consent and to increase awareness and interest in Norplant. In a clinical trial in California, 95% expressed a high level of satisfaction upon implant removal and 71% desired Norplant again; 91% recommended Norplant to friends. 82% reported the side effect of menstrual change; 66% reported 2 or more side effects. Clinical development is ongoing for other sustained release contraceptives. Norplant was developed by the International Committee for Contraceptive Research of the Population Council, and manufactured by Huhtamaki Oy/Leiras Pharmaceuticals in Turku, Finland. Clinical trials have been conducted since 1975. 20 nations have approved its use, and more than 1.5 million women use it. Silastic rubber tubing encapsulates 6 capsules of 36 mg/capsule crystalline levonorgestrel, a strong progestin. Implantation is done just under the skin in a fan shape; levonorgestrel is released at 80 mcg/day for 6 months, and 30-35 mcg/day for the remainder of use. The mode of action is not completely understood, but the assumption is that it is similar to the progestin-only pills. The mechanisms that alter fertility are 1) the change in hypothalamic-pituitary level to inhibit midcycle luteinizing hormone surge, while follicle stimulating hormone and estradiol levels remain within the normal range, 2) the thickening of the cervical mucus which prevents the entry of sperm into the upper genital tract, and 3) the suppression of the estrogen-induced cyclical maturation of the endometrium. It is not an abortifacient. Contraindications are few, but include active thrombophlebitis, undiagnosed abnormal genital bleeding, known or suspected pregnancy, benign or malignant liver tumors, and known or suspected breast cancer of progestin-dependent neoplasms.
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PMID:Innovations in contraception: the Norplant system. 159 35

From March 1, 1990 to August 31, 1991, there were four hundred and forty eight female patients undergoing major lower abdominal obstetric and gynecologic operations in our hospital. The most frequently performed operation in our series was Cesarean section (80.8%). Besides, there were operations for ectopic pregnancy, ovarian cyst, fallopian tube problems and abdominal total hysterectomy as well as radical hysterectomy for cervical cancer. Most of the operations were done under spinal anesthesia (91.3%). The rest were performed under epidural anesthesia (2.2%), general anesthesia (4.9%) or a combined anesthetic technique (1.3%). On one occasion, a Cesarean section was done during cardio-pulmonary resuscitation in the emergency room. Another parturient developed cardiac arrest during spinal anesthesia for Cesarean section with successful resuscitation. Otherwise, only minor complications such as post dural puncture headache (6.4%), nausea and vomiting (13.51%) and hypotension (38.2%) were found. All complications responded to conservative therapy that no prolonged hospitalization or unacceptable Apgar score in the newborns was noted. In addition, intra-operative blood transfusion was a rare occurrence. Thus, spinal anesthesia is a safe, effective, simple and inexpensive anesthetic method for major obstetric and gynecologic operations particularly in a rural hospital.
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PMID:Evaluation of anesthesia for obstetric and gynecologic intra-abdominal pelvic surgery in a rural hospital. 160 17

This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.
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PMID:An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs. 177 15

Although no postcoital method has been developed for safe and effective regular use, postcoital contraception is being offered in Canada and Western Europe on an emergency basis to people who experience such problems as a burst condom. It is little known in the US, however. The 1st commercial version of a postcoital method recently became available to women in England. A former postcoital contraceptive was diethylstilbestrol (DES) which has been linked to cancer in the daughters of women who had taken the drug to prevent miscarriage. A new postcoital contraceptive regime was developed by Albert Yuzpe and consists of 4 ordinary contraceptive pills combining estrogen and progestin to be taken over a 12-hour period. In the US, this is the formulaion of birth control pill marketed under the trade name Ovral by Wyeth Laboratories. England and Germany are the only countries in which the Yuzpe method is officially approved for use as an emergency postocital contraceptive, but the method is used to some degree in most European countries, being well-known in France and Denmark. The most frequent side-effect reported by Yuzpe is vomiting experienced by 29% of women; another 22% felt nauseated. Other side effects, e.g. headache, were infrequent. The findings of the Pregnancy Advisory Service and the Brook Advisory Centre in Britain are reported. Overall very few side effects were found. Postcoital contraceptive treatment may cause the length of the cycle in which it occurs to be irregular. Treatment before day 15 has been found to shorten the cycle, whereas treatment after day 15 lengthens it. The majority of women who become pregnant due to treatment failure tend to seek an abortion. Ectopic pregnancy incidence may also be a result of treatment failure. In 1981, the International Planned Parenthood Federation (IPPF) issued a statement endorsing the use of postcoital contraceptives. Reasons for using them include rape, problems with barrier methods, ineffective use of the pill and IUD expulsion. No drug company in the US has expressed interest in getting FDA approval to market a postcoital contraceptive, partly because its usage might not be widespread. Opposition to approval from groups who believe life begins at conception and consequently that postcoital contraceptives are an abortifacient is expected.
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PMID:Contraception--the morning after. 651 38

General anesthesia offers greater comfort for both the abortion patient and the operator. The combination of diazepam and ketamine which is rapidly reversible and offers a moderately deep anesthesia was used in 127 voluntary abortions and 3 therapeutic abortions. Patients ranged in age from 14-40 years and averaged 26, with 58% under 26. Patient weights ranged from 40-82 kg and averaged 56 kg. 43% were primaparas and average parity was 2.5. The average duration of the prenancy was 8.1 weeks. 10 patients were obese, 1 was asthmatic, 1 was a controlled hypertensive, 3 had cardiopathies, and 4 each had hepatitis and meningitis. 1 had treated epilepsy and 2 had serious depressive syndromes. 3 women had previously had voluntary abortions, 9 had had miscarriages, and 1 had had an extrauterine pregnancy. 17% had no fear or anxiety before the procedure, 56% had moderate levels, 28% had significant levels, and 19% had very high levels. 94% of the procedures were done by aspiration and in most cases a preliminary insertion of laminaria was done. The average duration of the procedure was 5 minutes, with extremes of 2 and 25 minutes. Patients were premedicated 1 hour before the procedure with intramuscular injections of 10 mg diazepam and 1/4 mg of atropine. For the induction, a butterfly needle with an antireturn system was used to inject 10 mg of diazepam and 1/4 mg of atropine diluted in 20 ml of distilled water. The patient was placed in the gynecological position and, if necessary, 5 mg of diazepam were added. Between .5-1 mg/kg of ketamine were injected in 10-15 seconds. The same dose was reinjected if the anesthesia was insufficient or the procedure was prolonged. A mixture of 40% oxygen and 60% nitrous oxide was administered if necessary. Patients remained in bed for 6 hours after awakening. 85% of patients received total doses of ketamine of .70mg/kg or less. Average duration of anesthesia was 9.2 minutes, with durations of less than 15 minutes in 94% of cases. On awakening 5% of patients had nausea and vomiting. 16% had minor psychic disturbances or disorientation, 8% had moderate problems with vocalization, and 2% had hallucinatory delirium with agitation. Overall, 20% of patients experienced headaches, 11% nausea, and 9% dizziness. It was concluded that the combination of diazepam .2 mg/kg and ketamine .5-.7 mg/kg provides well tolerated light anesthesia utilizable for outpatient abortions.
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PMID:[Diazepam and ketamine for voluntary interruptions of pregnancy]. 692 72

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

A case of ischemic optic neuropathy resulting from uterine hemorrhage is reported in which a 37-year-old white woman, gravida 1, para 0, was diagnosed at 8 weeks' gestation with a ruptured ectopic pregnancy. After diagnostic laparoscopy the patient underwent a minilaparotomy, cornual wedge resection, and right salpingectomy with a total estimated blood loss of 3000 ml. Her postoperative course was uneventful until postoperative day 4, when the patient complained of vision loss for the last 1 to 2 days, total body edema, and headache. Ophthalmologic examination revealed findings consistent with ischemic optic neuropathy. Multiple studies of the cerebrospinal fluid were negative, as were computed tomography studies and magnetic resonance imaging of the head. Ischemic optic neuropathy, whose pathogenesis is still unclear, is a rare complication of massive hemorrhage and may cause permanent vision loss.
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PMID:Ischemic optic neuropathy after hemorrhage from a cornual ectopic gestation. 942 71

A 16-year-old female presented to an emergency department with complaints of nausea and vomiting, dehydration, increasing weakness, and resting tremor. The past history included mild exercise-induced asthma. She denied sexual activity, but a urine test for beta-human chorionic gonadotropin was positive and she was transferred to a gynecology service for management of pregnancy. She also had primary amenorrhea and delayed growth for age. Further complaints included headaches accompanied with worsening of visual activity. Pelvic ultrasound revealed no intrauterine or ectopic pregnancy. Head CT scan showed a suprasellar tumor, better defined on an MRI as a hypothalamic tumor. Pathology following partial tumor resection revealed a mixed germ cell tumor with negative metastatic work-up.
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PMID:Another Positive Pregnancy Test. 1035 84

(1) Mirena degrees is a contraceptive intrauterine device delivering levonorgestrel. (2) Its assessment is based on two prospective randomised multicenter trials comparing it to a copper device. (3) It is not known whether it is any more difficult to insert than other devices. (4) Efficacy, in terms of absolute protection and risk of extrauterine pregnancy, appears to be very good, at least equal to that of copper devices. (5) Women were less subject to menorrhagia than were women using a copper device. (6) In clinical trials up to a third of women had amenorrhoea. Some women had spotting during the first three months, and other adverse effects (e.g. acne, headache and mastodynia) were more frequent than among women using copper devices.
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PMID:Levonorgestrel intrauterine device: new preparation. An alternative. 1150 15


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