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A study of intramuscular injections of depo medroxyprogesterone acetate (Depo Provera) as a postpartum contraceptive was undertaken in an attempt to determine the following: 1) the continuation rates for this contraceptive method in a postpartum family planning program; 2) to compare the continuation rates of Depo Provera given as a postpartum contraceptive with other postpartum contraceptive methods, as reported elsewhere; 3) the use-effectiveness of Depo Provera as a postpartum contraceptive method; 4) the side effects of postpartum injections; and 5) the reasons for discontinuation of this method. Between April 1969 and May 31, 1972 there were a total of 325 acceptors at the Family Planning Department of McCormick Hospital in Chiang Mai, Thailand. 217 of the women were acceptors of 3-month injections and 108 women were acceptors of 6-month injections. Of all acceptors, 94.2% received their 1st injection within 5 days of delivery. Cases continuing beyond 12 months were too few in number for significant statistical analysis. There were no known method failure pregnancies. Of the 325 postpartum acceptors of the 3-month and 6-month Depo Provera injections, 152 had discontinued the method by May 31, 1972. Of these, 47 were lost to follow up. The reasons for the discontinuation of the 105 remaining cases were bleeding problems (amenorrhea, prolonged, frequent or heavy bleeding, and irregular periods), other medical reasons (palpitation and dizziness, abdominal pain, pain at injection site, and melasma), and personal reasons.
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PMID:Use of a long-acting injectable contraceptive in a postpartum family planning program. 1226 37

69 healthy Mexican women using a new oral contraceptive (OC) containing 75 mcg of gestodene and 30 mcg of ethanol estradiol participated in a prospective study of the safety and efficacy of the method. All participants were evaluated on the s cycle day before beginning use and were questioned monthly about side effects and menstrual bleeding. 10 of the women were evaluated for cholesterol and triglyceride levels before use and after 4 and 8 months. The average age of the participants at admission into the study was 23.4 years. There were no pregnancies in 613 woman-months of use. The average blood pressure was 113.8 + or - 6.9 over 76.7 + or - 7.0 before use and 112.6 + or - 9.2 over 73.8 + or - 7.8 after 12 months of use. The average weight was 55.9 + or - 9.6 kg before use and 55.5 + or - 8.8 after 12 months of use. In the 1st treatment cycle 8 women reported spotting and 3 reported intermenstrual bleeding; the number reporting these signs gradually declined. The number reporting side effects was small and declined after the 1st treatment cycle. Dysmenorrhea declined significantly after the 1st cycle. The crude rate of termination was 44.9% after 1 year. 8 women (11.6%) terminated method use for reasons related to the method, including 2 for nausea and vomiting, 1 for nausea and dizziness, 2 for amenorrhea, and 1 each for intermenstrual bleeding, spotting, and increased blood pressure. Among the 10 women whose lipid and lipoprotein levels were tested, the average levels before and after 8 months respectively were 162.5 + or - 27.0 and 182.3 + or - 35.8 for total cholesterol, 86.5 + or - 29.5 and 120.0 + or - 45.0 for triglycerides, 45.7 + or - 9.3 and 60.6 + or - 6.5 for HDL cholesterol. In general these changes were not significant despite the tendency to increase especially of the triglycerides. The method thus appears to offer advantages for temporary fertility control among Mexican women.
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PMID:[Effectiveness and safety of a new combined oral contraceptive containing 75 micrograms gestodene and 30 micrograms ethinyl estradiol in Mexican women]. 1228 63

A new oral contraceptive (OC) formulation containing 30 mcg ethinyl estradiol and 150 mcg of desogestrel was used by 86 women aged 19-40 years for an average of 10.5 cycles/woman. 36 of the women were nulliparas. None had experienced any significant anomalies in their menstrual cycles prior to use. 25 had never used any contraception and the remainder had used a variety of methods, mainly other OC formulations. The OCs in the present study were taken for 21 days followed by 7 pill-free days. 67 of the women used the OCs for 12 consecutive cycles. None of the patients became pregnant in a total of 907 cycles of treatment, yielding a failure rate of 0. Cycles ranged from 26-31 days and averaged 28.05. Bleeding was normal but was of slightly shorter duration, 3-4 days compared to 4-5 days before treatment. Bleeding was moderate or average in 72.65% of cycles. 27 patients had periods of amenorrhea equivalent to 2-3 consecutive cycles. 53 of the total of 907 cycles were amenorrheic. 16.64% of cycles had some spotting or staining between the cyclic bleeding. Among side effects, only breast tension, which affected 18 patients, could definitely be attributed to the method. 11 patients experienced a lessening or disappearance of problems existing prior to treatment, including nervousness, headaches, nausea, and dizziness. No significant changes in weight, blood pressure, or gynecological conditions were found. Among 38 patients studied, there were no significant changes in glycemia, triglycerides, total cholesterol or transaminases.
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PMID:[A new progestin for contraceptive combination]. 1231 51

FDA has approved medroxyprogesterone acetate as Depo Provera Contraceptive Injection, effective for 3 months in preventing pregnancy in women. In clinical studies, the drug's failure rate was less than 1%. However, physicians must ensure that patients receive injections on schedule to prevent pregnancy. The recommended dose is 150 mg administered every 3 months by deep, intramuscular injection in the gluteal or deltoid muscle. Most women in clinical studies of Depo Provera experienced menstrual irregularities. As use continued, amenorrhea became common, reported by 57% of the women by the end of a year of treatment. Other side effects included weight gain, headache, nervousness, abdominal pain or discomfort, dizziness, and asthenia. Physicians should administer the drug only to women found not to be pregnant, because fetal exposure may lead to low birth weight and other problems. Recent data have demonstrated that longterm use may contribute to osteoporosis, and the drug's manufacturer, the Upjohn Company of Kalamazoo, Michigan, will conduct additional research to study this possible side effect. Contraindications are similar to those for other contraceptives and include undiagnosed vaginal bleeding, known or suspected malignancy of breast, thromboembolic disorders, cerebral vascular disease, and liver dysfunction. Depo Provera was developed in the 1960s and has been approved for contraception in many other countries. When FDA first reviewed data on the drug in the 1970s, animal studies raised questions about its potential to cause breast cancer. Since then, longterm controlled clinical studies in other countries have shown a risk of breast cancer comparable to oral contraceptives, and no increased risk for ovarian, liver, or cervical cancer. The studies also showed that the contraceptive injection reduced the risk of endometrial cancer. FDA approved the drug October 29, 1992.
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PMID:3-month contraceptive injection approved. 1231 15

To study the contraceptive effective in human beings, large doses of estrogen were administered to 2000 women between 14 and 52 years of age. In 1418 cases (71%) ethinyloestradiol (EO) was used, in 524 cases (26%) diethylstilbestrol (DS), and in 58 cases (3%) the estrogen administered was not recorded. Initially 2-5 mg of EO or 25-50 mg DS were given for 5 consecutive days. Later 5 mg EO or 50 mg DS were given for 5 days. Administration was to start within 48 hours of coitus, preferably within 24 hours. In 47.5% the unprotected coitus occurred between 12 and 16 days before the next expected menstruation, in 60.9% it occurred between 10 and 17 days, and in 9.6% (193 cases) the day of the cycle was not mentioned. There were 14 pregnancies among the 2000 women. In only 3 cases did the pregnancy occur after 3 mg doses of EO or 30 mg DS started within 36 hours. No pregnancies occurred after 5 mg EO or 50 mg DS. In 3 cases the pregnancy could have been the result of a later unprotected coitus. In another 3 cases medication was started after more than 48 hours. In cases of vomiting occurring within 1 hour after ingestion of a tablet, another tablet was given 30 minutes after an anti-emetic. If all tablets were vomited estradiol benzoate, 30 mg per day for 5 days, was injected. Other side effects were tender breasts, menorrhagia, headache, dizziness, abdominal pain, and amenorrhea. Changes in their cycle were reported by 662 women. Most stabalized after 1 cycle. Side effects prohibit this method for routine contraception but it could be valuable in special cases. There is as yet no statistical proof of its degree of effectiveness. The method of action of these drugs is not certainly known.
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PMID:Post-coital oestrogen in large doses. 1233 66

This study presents findings on the socio-demographic and health characteristics, continuation rates, menstrual disturbances, and changes in menstrual patterns as well as other side effects among a sample of 952 1st time acceptors of the injectable contraceptive Depo-Provera during 1978-1980 in Colombo, Sri Lanka. Those continuing to use the method were observed for 24 months. The reasons for discontinuation are discussed based on another study that focused on 321 discontinuers who received Depo-Provera from the same clinic. The overall continuation rates at 12 and 24 months were 58% and 29%, respectively. Relatively older and higher parity women had lower continuation rates than younger and lower parity women. The occurrence of amenorrhea rose sharply foloowing the 1st dose and stabilized such that about 1/3 of those continuing with Depo-Provera became amenorrheic. 1/4 of the women experienced menstrual disturbances such as spotting and irregular bleeding. Other side effects, including vomiting, headache, and dizziness, affected 6% of the women following the 1st dose, but declined gradually over time. Over the course of the observation, 41-66% of the women appeared to gain weight. The 2 primary reasons for discontinuing Depo-Provera were non-medical: 1) the desire to have another child and 2) the decision to be sterilized. The findings suggest that Depo-Provera has played a signinficant role in Sri Lanka in 2 ways: 1) its use has provided desired pregnancy spacing for those who wished to have another child and 2) it has assisted couples by providing them with time (without the fear of pregnancy) to decide to stop having children and then get sterilized.
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PMID:Depo-Provera use in Sri Lanka: acceptor characteristics, continuation and side effects. 1234 Nov 88

Depot medroxyprogesterone acetate (DMPA, Depo-Provera) is used for contraception by 8-9 million women in more than 90 countries, including the US, as of January 1993. Pharmacologically active levels of DMPA persist for 3-4 months following injection. A 150 mg dose is used most often for high contraceptive efficacy every 3 months. Norethindrone enanthate (NET-EN, Noristerat) is somewhat less widely used and is not marketed in the US. Injectables act primarily by inhibiting ovulation, lowering the levels of follicle-stimulating hormone and luteinizing hormone. Approximately 50% of women using DMPA for 1 year report amenorrhea whose occurrence is less frequent with NET-EN. Menstrual changes are the most frequent causes of discontinuation of injectables. In cases of heavy bleeding it is appropriate to undergo gynecological examination to rule out unrelated conditions, such as vaginitis, cervicitis, or cervical lesions. The use of conjugated estrogen (12.5-2.5 mg daily) for 10-21 days will minimize bleeding. Some women using injectables experience headache, dizziness, bloating of the abdomen or breast, and mood changes. Long-term use of DMPA or NET-EN can often result in 1-3 kg weight gain. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives was launched in 1979 to examine cancer risks with the use of DMPA in Thailand, Mexico, and Kenya. The relative risk of breast cancer was 1.21, which was statistically not significant. In women diagnosed with breast cancer under age 35, short-term exposure to DMPA was associated with a slightly increased breast cancer risk, which, however, was not associated with duration of use. DMPA dramatically lowers the risk of endometrial cancer for at least eight years following discontinuation of its use. DMPA did not alter the risk of cervical cancer. Fertility returns in 70% of former users within 12 months; it is suitable for postpartum and lactating women, and provides other noncontraceptive benefits.
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PMID:Injectable contraception: the USA perspective. 1234 20

The study was conducted to compare cycle control, efficacy and side effects of two oral contraceptives containing 30 microg ethinylestradiol (EE)/150 microg levonorgestrel (LNG) and 35 microg ethinylestradiol (EE)/250 microg norgestimate (NGM). An open-label, randomized, comparative study was conducted in which 140 healthy women received the 30 microg EE/150 microg LNG or 35 microg EE/250 microg NGM preparation for six treatment cycles. There were no significant statistical differences between both groups in terms of cycle length and amount of withdrawal bleeding. The mean duration in the 35 microg EE/250 microg NGM group was longer than 30 microg EE/150 microg LNG group with significant statistical difference. More patients in 35 microg EE/250 microg NGM group experienced BTT at each cycle compared with the 30 microg EE/150 microg LNG group, but was not statistically significant. There was no amenorrhea nor pregnancies occurring in either group. No significant changes in body weight or blood pressure were found in both groups. The incidence of adverse events in both groups was low and tended to decrease with time. Statistically significant differences were observed for headache and dizziness, which occurred more in the 30 microg EE/150 microg LNG group. In conclusion, 35 microg EE/250 microg NGM provides reliable contraceptive efficacy. It also provides good cycle control equal to 30 microg EE/150 microg LNG with a lower incidence of minor adverse effects such as headache and dizziness compared to 30 microg EE/150 microg LNG.
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PMID:Clinical comparative study of oral contraceptives containing 30 microg ethinylestradiol/150 microg levonorgestrel, and 35 microg ethinylestradiol/250 microg norgestimate in Thai women. 1249 31

The association between macroamylasaemia and coeliac disease in Down syndrome with multiple autoimmune abnormalities has never been reported. A 40-year-old woman with a 15-year history of immunoglobulin A and immunoglobulin M hypergammaglobulinaemia, chronic diarrhoea, persistent mild aspartate aminotransferase (AST) elevation and anaemic syndrome was admitted to hospital because in the previous 3 months she had developed amenorrhoea, dizziness, alopecia, constipation, pallor and asthenia. Biochemical and immunological analyses showed macroamylasaemia. The patient presented clinical and intestinal histopathological features of coeliac disease. Immunological abnormalities included the presence of antigliadin, antiendomysium, antitransglutaminase, antinuclear, antismooth muscle and anti-SSA/Ro antibodies. Macroamylase resulted in a complex of amylase and immunoglobulin A. Later clinical follow-up of a gluten-free diet showed a transitory decrease in seric immunoglobulin A and macroamylase with persistent autoantibodies and AST elevation. An intestinal mucosal immune disorder could lead to coeliac disease and macroamylasaemia in a patient with Down syndrome presenting other immune alterations.
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PMID:Macroamylasaemia, IgA hypergammaglobulinaemia and autoimmunity in a patient with Down syndrome and coeliac disease. 1273 20

This purpose of this prospective and descriptive study was to evaluate the utility of a calcium-channel inhibitor, i.e. nifedipine, for management of preterm labor in our work setting in terms of safety and cost-effectiveness in comparison with betamimetics classically used for this indication. Study was carried out over a six-month period in the department of Gynecology-Obstetrics Department of Ignace Deen National Hospital in Conakry, Guinea. Pregnant women meeting the following criteria were included: 28 to 33 weeks of amenorrhea, six days of hospitalization either for preterm labor or for another diagnosis that was associated with the occurrence of preterm labor during hospitalization, and absence of contraindications for tocolysis using nifedipine. A total of 42 women were included. Pregnancy was extended for more than 48 hours after the first dose of nifedipine in 86.8% of cases. Administration of nifedipine failed in 5 cases including one case in which it was necessary to change the tocolytic and 4 cases in which delivery occurred less than 48 hours after the first dose of nifedipine. In 68% of cases, 90 mg of nifedipine were sufficient to stop uterine contractions within 48 hours. In 39.5% of cases, no side effects were observed. Adverse effects in the other cases were dizziness (39.5%) and headache (18.4%). The mean term of delivery was 36 weeks +/- 5 days of amenorrhea with a mean extension of 6.2 weeks. Apgar score was low in 30.5% of the newborns and normal in 69.5%. One newborn (2.8%) died. The results of this study indicate that nifedipine is an effective, economical and safe drug for tocolysis and that it can be used as an alternative to betamimetis in countries with limited resources. An information campaign is needed to promote use of nifedipine as a tocolytic in obstetrical facilities of our country.
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PMID:[Management of pre-term labor: use of nifedipine in Conakry, Guinea]. 2048 48


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