RESUMO
A comparative clinical trial of two combined oral contraceptives differing only in estrogen type and dosage was conducted at the Centro de Investigaciones Hideyo Noguchi in Merida, Yucatan, Mexico. The trial was designed to determine the differences between Norinyl 1 + 50 (Syntex) and Norinyl 1 + 35 (Syntex) in rates of discontinuation and frequency of selected side-effects which might contribute to method discontinuation. Three hundred women were randomly assigned to either the Norinyl 1 + 35 group or to the Norinyl 1 + 50 group and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. In the Norinyl 1 + 35 group, more women experienced an increase in intermenstrual bleeding (primarily staining and spotting) (p less than 0.05), breast discomfort (p less than 0.05) and nausea than in the Norinyl 1 + 50 group. There was a significantly higher discontinuation rate for personal reasons, such as desired change of method and method not needed, among the women taking Norinyl 1 + 35 (p less than 0.05). The largest number of discontinuations comprised women discontinuing for menstrual problems in both groups. The life-table total discontinuation rate at 12 months was 52.0 for the Norinyl 1 + 35 group and 50.7 for the Norinyl 1 + 50 group. The lost-to-follow-up rates at 12 months were 17.8 for the Norinyl 1 + 35 group and 22.8 for the Norinyl 1 + 50 group.
Assuntos
Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Sintéticos/efeitos adversos , Mestranol/efeitos adversos , Noretindrona/efeitos adversos , Adolescente , Adulto , Anticoncepcionais Orais Combinados/administração & dosagem , Anticoncepcionais Orais Sintéticos/administração & dosagem , Combinação de Medicamentos , Feminino , Humanos , Mastite/induzido quimicamente , Mestranol/administração & dosagem , México , Estudos Multicêntricos como Assunto , Náusea/induzido quimicamente , Noretindrona/administração & dosagem , Cooperação do Paciente , Distribuição Aleatória , Hemorragia Uterina/induzido quimicamenteRESUMO
A comparative clinical trial of two combined oral contraceptives (OCs) with equivalent estrogen content, but different amounts of progestogens, was conducted at the Centro Medico Especializado em Planejamento Familiar in Rio Clara, Brazil. The study was designed to determine the differences in discontinuation rates between Norinyl 1/35 (Syntex) and Brevicon (Syntex) as well as the frequency of selected side effects which might contribute to method discontinuation. Both OCs contain 0.035 mg of ethinyl estradiol; Brevicon contains 0.5 mg and Norinyl 1/35 contains 1 mg norethindrone. Three-hundred women enrolled in the study were randomly assigned to either the Norinyl 1/35 or Brevicon OCs and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Intermenstrual bleeding was reported by significantly more women in the Brevicon group than in the Norinyl group (p less than 0.05), and significantly more Brevicon users reported an increase in intermenstrual bleeding. At the end of the study period, no differences were found between the two OC groups in terms of discontinuation rates, but a large number of women in each group discontinued for menstrual problems. The total discontinuation rates at 11 months for both groups were extremely high: 68.2 for the Norinyl 1/35 group and 75.2 for the Brevicon users. The largest group of discontinuations were comprised of those discontinuing for menstrual problems, other personal reasons, planned pregnancy and side effects.
Assuntos
Anticoncepcionais Orais Hormonais , Etinilestradiol , Mestranol , Noretindrona , Adulto , Ensaios Clínicos como Assunto , Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Hormonais/efeitos adversos , Combinação de Medicamentos , Etinilestradiol/efeitos adversos , Feminino , Humanos , Mestranol/efeitos adversos , Noretindrona/efeitos adversos , Fatores SocioeconômicosRESUMO
A study designed to monitor uterine placement of IUDs inserted immediately postpartum using echosonography was conducted at the Hospital de Gineco Obstetricia No. 23, "Dr. Ignacio Morones Prieto" in Monterrey, Mexico. TCu220 and Delta T IUDs were randomly assigned to, and inserted in women immediately following a normal vaginal delivery. Ultrasound examinations were to be performed within 60 min postinsertion, at 24 h postinsertion and at 1- and 3-month follow-up visits. There were no differences in the expulsion rates of the two device groups. Data are presented on the readings taken at the ultrasound examinations of the distance between the fundus and the upper part of the stem of the T. These differences differed significantly between the two device groups at the first ultrasound reading only (P less than or equal to 0.01). No relationship was found between the incidence of expulsion and the distance between the IUD and the fundus at any of the readings.
PIP: A study designed to monitor uterine placement of IUDs inserted immediately postpartum using echosonography was conducted at the Hospital de Gineco Obstetricia No. 23, "Dr. Ignacio Morones Prieto" in Monterrey, Mexico. TCu220 and Delta T IUDs were randomly assigned to, and inserted in women immediately following a normal vaginal delivery. Ultrasound examinations were to be performed within 60 minutes post-insertion, at 24 hours postinsertion and at 1- and 3-month follow-up visits. There were no differences in the expulsion rates of the 2 device groups. Data are presented on the readings taken at the ultrasound examinations of the distance between the fundus and the upper part of the stem of the T. These differences differed significantly between the 2 device groups at the 1st ultrasound reading only. No relationship was found between the incidence of expulsion and the distance between the IUD and the fundus at any of the readings.
Assuntos
Dispositivos Intrauterinos de Cobre , Período Pós-Parto , Ultrassonografia , Feminino , Seguimentos , Humanos , Expulsão de Dispositivo Intrauterino , México , Gravidez , Distribuição Aleatória , Fatores de TempoAssuntos
Dispositivos Intrauterinos de Cobre , Dispositivos Intrauterinos , Ensaios Clínicos como Assunto , Costa Rica , Feminino , Humanos , Expulsão de Dispositivo Intrauterino , Dispositivos Intrauterinos/efeitos adversos , Dispositivos Intrauterinos de Cobre/efeitos adversos , Período Pós-Parto , Gravidez , Distribuição AleatóriaRESUMO
The development of the Copper 1 IUD (Cu 1) was an attempt to decrease the incidence of unpleasant side effects (primarily pain and bleeding) associated with IUD use, by reducing the size of the vector carrying the copper. The Cu 1 consists of a straight stem with crossarms in an "X" configuration, designed to anchor the IUD in place. The device was tested in 98 interval women in the Hospital Barros Luco in Santiago, Chile who were asked to return at 1, 3, 6, and 12 months post-insertion for follow-up examinations. There was only 1 removal for bleeding and pain; however, both pregnancy and expulsion rates were high at 9.0 and 16.0 respectively after 12 months. The crossarms did not keep the device in place as expected. The high pregnancy rate may have been due to the reduced size of the IUD and to increased displacement/expulsion. Future efforts to decrease IUD size will be dependent on designing an IUD which will be less easily expelled or displaced.
Assuntos
Coeficiente de Natalidade , Anticoncepção , Cobre , Diagnóstico , Estudos de Avaliação como Assunto , Serviços de Planejamento Familiar , Hemorragia , Dispositivos Intrauterinos , Metais , Dor , Taxa de Gravidez , Projetos de Pesquisa , Pesquisa , Sinais e Sintomas , América , Fenômenos Químicos , Química , Chile , Demografia , Países Desenvolvidos , Países em Desenvolvimento , Doença , Fertilidade , Compostos Inorgânicos , América Latina , População , Dinâmica Populacional , América do SulRESUMO
An analysis is presented of a study of the Copper-T 200 (CuT 200) intrauterine device at the Barros Luco Hospital in Santiago, Chile. The devices were inserted in 1142 postpartum patients. The expulsion rate was high, 32.1% at 3 months. Of the 372 women who expelled devices, 349 received a replacement CuT 200. The expulsion rate for these reinsertions was 7.7% at 12 months with a continuation rate of 86.4%.
PIP: An analysis is presented of a study of the Copper-T 200 (CuT 200) IUD at the Barros Luco Hospital in Santiago, Chile over the August 16, 1976 June 30, 1978 period. 1142 IUDs were inserted in postpartum women, the majority of whom (96.1%) received their IUDs within 72 hours of giving birth. Data were recorded on standard forms designed to obtain demographic and medical information and were processed by the International Fertility Research Program (IFRP). The CuT 200 used in this study consisted of a plastic T-shaped device with 200 sq mm of copper wire wound around the vertical arm. The mean age of women in this study was 24.0 years; the mean number of live births was 2.4 57 (5.0%) of the women reported having had 1 or more induced abortions. There was no previous incidence of pelvic inflammatory disease (PID) reported by the patients, and none of them showed evidence of inflammation/infection of the genital organs at the time of insertion. There were no complications or complaints reported for women at insertion. There were no complications or complaints reported for women at insertion. 945 (82.7%) patients returned for 1 or more follow-up visits. Cervical perforation was found at follow-up in 2 (0.2%) women, and 9 (0.7%) women were hospitalized during the study period. From this latter group, women were hospitalized because of retained placentas and 2 women because of a perineotomy infection. 4 women were hospitalized for endometritis and 1 for the spontaneous abortion of a pregnancy conceived with the IUD in situ. 158 (13.8%) women were diagnosed as having 1 or more incidents of inflammation/infection. Included among these were 19 (1.7%) cases of adnexitis and 20 (1.8%) cases of endometritis. Dysmenorrhea was reported by 23.7% of the women. Intermenstrual bleeding/pain was reported by 297 (20.0%) of the women and 113 (9.9%) reported intermenstrual spotting. The continuation rate after 1 year was 55.5. The 3 month termination rates were 0.3 for accidental pregnancy, 32.1 for expulsion/displacement, 0.2 for bleeding/pain, and 1.3 for other medical reasons. Most expulsions occurred within 1 month postinsertion. 372 (32.6%) women who received CuT 200s in this study expelled them; 370 of them received a replacement IUD. 349 received a 2nd CuT 200 and 21 received Lippes Loop IUDs. 92.8% of the women who received replacement CuT 200s returned for follow-up and were diagnosed as having 1 or more infections. 19 of the women who expelled their 1st CuT and received a replacement also expelled their 2nd device and had a 3rd CuT 200 inserted. No complications or complaints were reported at insertion for this group. At follow-up 4 women were diagnosed with trichmonas and 1 with an unspecified inflammation/infection. 7 women expelled their IUDs and 1 woman had her IUD removed for other personal reasons.