RESUMO
A total of 1,904 women, aged 15-38, used an injectable contraceptive combination of 90 mg dihydroxyprogesterone acetophenide with 6 mg estradiol enanthate, given once during each menstrual cycle between the 7th and 10th day, and preferably on the 8th day of the cycle, for a total of 17,576 cycles. Of these 1,904 women, 1,197 completed 12 cycles of use of the injectable combination. One subject became pregnant during the trial, resulting in a cumulative pregnancy rate of 0.07%. Principal reasons for discontinuation were personal, non-medical reasons, such as lost to follow-up, no longer wished to continue, protocol violation, desire to change to another contraceptive method, moved away, or other personal reasons. Mean weight of 1,901 subjects at admission to the trial was 53.5 +/- 0.2 kg and this increased to 54.3 +/- 0.3 kg after 12 cycles of use. Approximately 50% of subjects experienced menstrual bleeding similar to normal throughout the study period. The most frequent menstrual abnormality was irregular bleeding, experienced by approximately one-third of subjects.
Assuntos
Acetofenida de Algestona/administração & dosagem , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Estradiol/análogos & derivados , Adolescente , Adulto , Método Duplo-Cego , Estradiol/administração & dosagem , Feminino , Humanos , Injeções , Ciclo Menstrual , Satisfação do Paciente , Gravidez , Hemorragia Uterina/induzido quimicamenteRESUMO
A phase III clinical study was carried out among 534 fertile Latin American women to evaluate cycle control, side effects, and contraceptive efficacy of a once-a-month combined injectable, Mesigyna, consisting of 50 mg norethisterone enanthate and 5 mg estradiol valerate. The pregnancy rate at 1 year was 0 per 100 woman-years for a total experience of 4688 woman-months. The overall discontinuation rate at one year was 17.9%. Discontinuation rate for bleeding problems was 5.1%. The Colombian women had a significant increase (p <0.001) in bleeding problems compared to other countries. The discontinuation rate for amenorrhea was 1.1%. There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight gain after one year of use was 1.02 kg. Mesigyna is an appropiate once-a-month injectable contraceptive for Latin American women since it is highly effective and its perception of normal menstrual bleeding is of importance in the Latin American population.
Assuntos
Anticoncepcionais Femininos , Estradiol/análogos & derivados , Noretindrona/análogos & derivados , Adolescente , Adulto , Amenorreia/induzido quimicamente , Pressão Sanguínea , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Combinação de Medicamentos , Feminino , Humanos , Injeções , América Latina , Gravidez , Hemorragia Uterina/induzido quimicamente , Aumento de PesoRESUMO
Many biomedical aspects of emergency contraception have been investigated and documented for >30 years now. A large number of social science questions, however, remain to be answered. In this article, we review the rapidly growing but geographically lopsided literature on this topic. Using computer database searches supplemented by reference reviews and professional correspondence with those active in the field, we gathered literature on the social science and service delivery aspects of emergency contraception published in English up through December 1998, as well as a few unpublished papers from the same time and slightly later, representing regions where published material is practically nonexistent. Methodologically acceptable papers are summarized in our tables and text, and form the basis for suggested improvements in existing emergency contraceptive services. The review also offers ideas for designing new emergency contraception services where they do not yet exist. We conclude by proposing an agenda for further social science research in this area.
Assuntos
Anticoncepcionais Pós-Coito , Adolescente , Adulto , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Serviços de Saúde , Humanos , MEDLINE , Educação de Pacientes como Assunto , Gravidez , Inquéritos e QuestionáriosRESUMO
PIP: According to research conducted in Chile, the Dominican Republic, Egypt, Finland, Singapore, Thailand, and the US, the levonorgestrel contraceptive implant Norplant offers up to 7 years of effective protection from pregnancy. The research involved two independent studies of 1210 women aged 18-40 in the seven countries using soft-tubing as well as hard-tubing Norplant implants. Overall, results indicated that cumulative 7-year pregnancy rates among Norplant users are comparable to rates among women who have been surgically sterilized. Moreover, among women ages 18-33 the 7-year Norplant pregnancy rates are comparable to the median rates of tubal sterilization methods for women of the same age and duration of use. For women ages 34 and older, without regard to weight at admission, the 7-year effectiveness of soft-tubing Norplant equals or surpasses that of tubal sterilization.^ieng
Assuntos
Anticoncepção , Estudos de Avaliação como Assunto , Levanogestrel , Segurança , África , África do Norte , América , Ásia , Sudeste Asiático , Região do Caribe , Chile , Anticoncepcionais , Anticoncepcionais Femininos , Países Desenvolvidos , Países em Desenvolvimento , República Dominicana , Egito , Europa (Continente) , Serviços de Planejamento Familiar , Finlândia , Saúde , América Latina , Oriente Médio , América do Norte , Saúde Pública , Países Escandinavos e Nórdicos , Singapura , América do Sul , Tailândia , Estados UnidosRESUMO
The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/L from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of four PVRs. No pregnancies occurred in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.
PIP: This study compares the contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile and a Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers used the PVR and 262 used T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/l from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of 4 PVRs. There were no pregnancies in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were seen in the PVR group. Breast-feeding performance and infant growth were similar in both groups. These results prove the high efficacy and safety of the PVR for nursing women. This has led to the registration of the PVR by Chilean health authorities.
Assuntos
Aleitamento Materno , Dispositivos Anticoncepcionais Femininos/normas , Leite Humano/efeitos dos fármacos , Progesterona/farmacocinética , Adulto , Amenorreia/induzido quimicamente , Peso ao Nascer , Peso Corporal , Chile , Colposcopia , Dispositivos Anticoncepcionais Femininos/efeitos adversos , Feminino , Hemoglobinas/análise , Humanos , Lactente , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos de Cobre/normas , Lactação , Masculino , Paridade , Pacientes Desistentes do Tratamento , Satisfação do Paciente , Progesterona/sangue , Progesterona/farmacologia , Radioimunoensaio , Vagina/efeitos dos fármacosRESUMO
OBJECTIVE: To determine the effects of oral contraceptive (OC) treatment on maternal iron and copper metabolism during lactation. DESIGN: Observational study. SETTING: Private and public clinics in Brazil. PATIENT(S): Lactating mothers attending the family planning clinic of the University of Brasilia. INTERVENTION(S): The OCs used were a combination pill (0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol) and a minipill (0.35 mg of norethidrone). Blood and breast milk samples were collected before and after a measured period of OC treatment. MAIN OUTCOME MEASURE(S): Iron and copper concentrations were studied in the serum and breast milk of 54 breast-feeding mothers who had been advised by their physicians to use an OC, and in a control group. RESULT(S): Regression analysis was performed using a model that took into consideration socioeconomic status, number of children, duration of previous lactation, type of OC, length of treatment, and age. Repeated measurements (before and after OC treatment) showed that only copper concentrations in breast milk were significantly affected by stage of lactation. During the study period, which varied from 2-15 weeks, the decline in iron concentrations in breast milk was negligible, whereas copper concentrations decreased by 50%. CONCLUSION(S): The use of OCs does not appear to affect significantly the secretion of iron and copper in breast milk during the first 6 months of lactation.
PIP: This study examines the effects of oral contraceptive (OC) treatment on maternal iron and copper metabolism during lactation. The sample included lactating mothers attending the family planning clinic at the University of Brasilia. Participants were divided into 3 groups: 1) mothers who were taking combination pills (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol); 2) those who were taking minipills (0.35 mg norethindrone); and 3) a control group. Blood and breast milk samples were collected before and after a measured period of OC treatment. Results showed no significant effects of OC use on either iron or copper concentrations in serum during lactation. However, copper concentrations were significantly affected with the stage of lactation (iron, P = 0.9619; copper, P = 0.0002) as reflected in the multivariate model analysis. Therefore, the use of OCs does not appear to affect significantly the secretion of iron and copper in breast milk during the first 6 months of lactation.
Assuntos
Anticoncepcionais Orais , Cobre/análise , Ferro/análise , Leite Humano/química , Adolescente , Adulto , Anticoncepcionais Orais Combinados , Cobre/sangue , Feminino , Humanos , Ferro/sangue , LactaçãoRESUMO
Because of its unique features, the contraceptive effectiveness and tolerance during breast-feeding of 16-methylene-17 alpha-acetoxy-19-nor-4-pregnene-3,20-dione (elcometrine), delivered within a single subdermal capsule of medical grade polydimethylsiloxane, was investigated. Unlike other progestational steroids, elcometrine has no affinity for androgen and estrogen receptors and is inactive by the oral route. A total of 66 breast-feeding women receiving elcometrine by the subdermal route were enrolled in the study, and 69 women who elected to use Copper-T380 intrauterine devices (IUD) served as control subjects. The women and their infants were observed until the end of the first postpartum year. There were no significant differences in growth and development measurements among the infants in the elcometrine and control groups. The percentage of infants continuing to breast-feed at 3 and 6 months was significantly higher in the elcometrine group. There were no significant differences between the concentration of elcometrine in the mother's blood and milk. At 75 days, blood levels of elcometrine in the infants were near the undetectable and were significantly lower than the levels in maternal blood or milk (p < 0.01). In 15 of 25 infants, blood levels of elcometrine were at the limit of assay sensitivity or undetectable. Two pregnancies occurred in women using IUD, whereas none occurred in those using implants. There were menstrual bleeding irregularities in both groups. A single elcometrine capsule placed subcutaneously at 6-monthly intervals appears to be an effective method of contraception for lactating women and results in blood concentrations of nursing infants at or near undetectable levels.
PIP: Discusses the effects of the use of a single implant of elcometrine (ST-1435), a nonorally active progestin, as a long acting contraceptive for postpartum nursing women in Maternidade Climerio de Oliveira in Salvador, Bahia, Brazil. A total of 135 women aged 18-35 years having a singleton term delivery, fully breast-feeding on demand, planning to breast-feed for 6 months postpartum, and requesting effective contraception were recruited. The method was initiated for 6 weeks postpartum. Results showed that 66 breast-feeding women used elcometrine implants, while 69 women preferred an IUD insertion. The contraceptive efficacy of lactation is high for women breast-feeding on demand, particularly in those who remain in amenorrhea during the 6 months postpartum; in these women, elcometrine implant and IUD prevented pregnancy effectively. Breast-feeding was significantly higher (p 0.05) in the elcometrine group at 3 and 6 months, while at 9 and 12 months there was no statistical difference. The differences in type, frequency of supplementary feeding, and anthropometric measures between the two contraceptive groups were not significant. Menstrual irregularities were present in both groups. Thus, elcometrine could be best alternative and the most effective method of contraception for lactating women.
Assuntos
Aleitamento Materno , Desenvolvimento Infantil , Anticoncepcionais Femininos/administração & dosagem , Dispositivos Intrauterinos de Cobre , Norprogesteronas/administração & dosagem , Período Pós-Parto , Adulto , Amenorreia , Constituição Corporal , Peso Corporal , Anticoncepcionais Femininos/farmacocinética , Implantes de Medicamento , Feminino , Humanos , Lactente , Menstruação , Leite Humano/química , Norprogesteronas/farmacocinéticaRESUMO
OBJECTIVE: To determine the influence of depot medroxyprogesterone acetate (MPA) on bone mineral density when used as a contraceptive method. DESIGN: Cross-sectional study. SETTING: Academic tertiary-care hospital. PATIENT(S): Fifty premenopausal women who had used depot MPA as a contraceptive method for > or =1 year and 50 women who had never used hormonal contraceptive methods. INTERVENTION(S): Bone mineral density was evaluated at the midshaft and at the distal radius of the nondominant forearm using single x-ray absorptiometry. MAIN OUTCOME MEASURE(S): Bone mineral density. RESULT(S): Bone mineral density at the midshaft of the forearm was lower in depot MPA users than in women who had never used hormonal contraceptive methods, but the difference was not statistically significant. At the distal portion, bone mineral density was significantly lower in the study group. The duration of depot MPA use was not related to bone mineral density. CONCLUSION(S): Women > or =35 years of age presented with a lower bone mineral density only at the distal portion of the forearm after the use of depot MPA for > or =1 year. However, this decrease was not related to the duration of depot MPA use. It is not possible to conclude that women who use depot MPA are at risk of osteoporosis.
PIP: The impact of depot medroxyprogesterone acetate use on bone mineral density was assessed in a cross-sectional study of 100 women recruited from a teaching hospital in Campinas, Brazil, during 1996-98. Bone mineral density, as evaluated at the midshaft and distal radius of the nondominant forearm by single x-ray absorptiometry, was compared in 50 women 35-45 years of age who had been using Depo-Provera for contraception for 1 year or more (mean duration, 46.4 +or- 38.6 months) but had never used any other hormonal method and 50 age- and weight-matched women who had never used any form of hormonal contraception. Although mean bone mineral density at the midshaft of the forearm was lower in Depo-Provera users than nonusers of hormonal contraception (0.459 +or- 0.042 vs. 0.474 +or- 0.049 g/sq. cm), the difference was not statistically significant. At the distal portion, bone mineral density was significantly lower in Depo-Provera users than nonusers of hormonal methods (0.362 +or- 0.040 vs. 0.392 +or- 0.049 g/sq. cm, p 0.001). The duration of Depo-Provera use was not related to bone mineral density, even when women had used the method for more than 5 years. Multiple regression analysis indicated that 4 pregnancies, White race, and Depo-Provera use were significantly associated with lower bone mineral density at the midshaft section of the forearm; at the distal section of the forearm, these variables were Depo-Provera use, more than 4 pregnancies, White race, older age at menarche, and habitual coffee drinking. These findings do not provide sufficient evidence to conclude that Depo-Provera users are at increased risk of osteoporosis.
Assuntos
Densidade Óssea/efeitos dos fármacos , Anticoncepcionais Femininos/farmacologia , Antebraço , Acetato de Medroxiprogesterona/farmacologia , Rádio (Anatomia)/efeitos dos fármacos , Ulna/efeitos dos fármacos , Adulto , Estudos Transversais , Feminino , Humanos , Modelos Lineares , Pessoa de Meia-Idade , Pré-Menopausa , Estudos Retrospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
A prospective study was conducted with 430 new depot medroxyprogesterone acetate (DMPA) acceptors to estimate continuation rates and investigate factors associated with length of use. Data were collected on services received and sociodemographic characteristics of participants. Women were enrolled over the course of 1 year and were followed for up to 13 months. Failure to return to the same clinic within 104 days of the last injection was the outcome of interest. The 3-, 6-, 9-, and 12-month continuation rates were 68%, 67%, 55%, and 51%, respectively. In the bivariate analysis, women who were told to return to the clinic for side effects were more likely to continue using DMPA than those who were not given such advice (p <0.05). Likewise, women who received information on DMPA efficacy, side effects, and amenorrhea were more likely to continue using DMPA compared to those who did not receive such information (p <0.05). A proportional hazards regression model was constructed to estimate the simultaneous effect of various factors on length of use. In results consistent with the bivariate analysis, women who were told to return to the clinic were 2.7 times more likely to continue using DMPA compared to women who did not receive that advice. Likewise, women who were told about the possibility of amenorrhea were 2.5 times more likely to continue using DMPA compared to those who did not receive that information. The regression model also identified new factors such as number of children, attitude toward menstruation, lactating at admission, and spousal input on method choice. The findings suggest that providers play an important role in ensuring the highest possible continuation rates for DMPA.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Acetato de Medroxiprogesterona/administração & dosagem , Cooperação do Paciente/estatística & dados numéricos , Educação de Pacientes como Assunto/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Adolescente , Adulto , Bolívia , Anticoncepcionais Femininos/efeitos adversos , Escolaridade , Feminino , Humanos , Lactação , Masculino , Estado Civil , Acetato de Medroxiprogesterona/efeitos adversos , Distúrbios Menstruais , Estudos Multicêntricos como Assunto , Paridade , Cooperação do Paciente/psicologia , Modelos de Riscos Proporcionais , Estudos ProspectivosRESUMO
PIP: Emergency contraception (EC) refers to methods usually based on standard contraceptives for use within a few days of unprotected intercourse to prevent pregnancy. The most common, used in many countries for over 2 decades, is based on high doses of combined oral contraceptives (OCs) taken within 72 hours of unprotected coitus, followed by a second dose 12 hours later. Copper IUDs inserted within 5 days also provide protection. The "morning-after pills" have no effect on a pregnancy that is already established, do not cause abortion, and have not been shown to cause congenital malformations in case of failure. Emergency OCs entail no risk for most women, and occasional use is not believed to carry the same risks as regular OC use for women at cardiovascular risk, although progestin-only EC may be indicated. Only about 2% of women who use EC become pregnant. EC is useful in case of method failure, unexpected sexual relations, or rape. EC may reduce recourse to abortion by preventing unwanted pregnancy. There is no evidence that availability of EC increases sexual activity among young people. Women are not likely to replace their regular methods with emergency OCs because of the side effects, greater expense, and lower efficacy. Adding EC to existing reproductive health services is not costly in itself and offers savings in care for unwanted pregnancy and abortion.^ieng