A comparative clinical trial of Norinyl 1 + 35 versus Norinyl 1 + 50 in Merida, Yucatan, Mexico.

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.

Television and adolescent sexuality.

Existing studies of the sexual content of television programming and advertising and the effects of this content on adolescent viewers are reviewed. Content studies show that the frequency of sexual references have increased in the past decade and are increasingly explicit. Studies of the effects of this content, while scarce, suggest that adolescents who rely heavily on television for information about sexuality will have high standards of female beauty and will believe that premarital and extramarital intercourse with multiple partners is acceptable. They are unlikely to learn about the need for contraceptives as a form of protection against pregnancy or disease. Suggestions for future research and trends in television programming policies are explored.

PIP: US television's effects on 2 broad areas of sexuality: 1)sexual beauty standards; and 2) sexual activity, including sexual intercourse are focused on. Physical attractiveness and thinness are often emphasized in television advertising and programming. The current attractiveness standard on television and in magazines is the slimmest since the 1920s. Commercials often use sexual attractiveness to sell products. Advertising has become much more explicit. References to and depictions of sex activity have gone up in the last 10 years. An average adolescent television viewer watched between 1900 and 2400 sexual references on television in 1985. The average rate of the frequency of sexual acts and references of R-rated movies is 7 times higher than prime-time commercial television. Television can have a powerful effect on adolescents' sex beliefs, especially beliefs about marital fidelity, marital stability, and female sexuality. The few studies done indicate that teenagers who get most of their information about sexuality from television will have higher criteria for female beauty and will accept the idea of premarital sex and extramarital intercourse with one or more partners. Content analyses should be continued to see how models of sexual attractiveness are used by students. Research needs to be done on the idea that women are often shown as sex objects available for men's pleasure. How sexual encounters are initiated should be researched. Content analyses should consider the consequences and context of sexuality that is televised. All adolescents do not interpret what they see in the same way. Subsequent behavior is based on the adolescents' content perception. Experimental studies are needed to set up causal sequence. Longitudinal studies are needed to set up to what extent these effects last and are "generalizable." Each of the 3 television networks had a "censor" board. But, they would not let condoms or other contraceptives be advertised. However, the networks now have a lot of competition. Some think this will loosen network standards and encourage more explicitness. However, portrayals of sexuality on television are now also becoming more responsible, with public service messages on safe sex.

A comparative clinical trial of Norinyl 1/35 versus Brevicon in Rio Clara, Brazil.

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.

Long-term use of intrauterine devices.

PIP: Analysis was performed of data relative to 10,001 IUD insertions (mostly Lippes Loop D and C) in 8091 women in Slovenia between 1965 and 1972. Data were gathered on sociodemographic characteristics of the users; cumulative life-table rates per 100 women for removals due to pregnancy, expulsion, bleeding/pain, other medical reasons, and personal reasons as well as continuation rates and the rate of follow-up; and the proportion of women with bleeding, spotting, vaginitis, and pelvic inflammatory disease (PID) at 1-, 5-, and 10-year follow-up. The most frequent reason for removal was bleeding. Increased duration of IUD use was associated with a smaller number of women with bleeding and PID episodes. Of those with first insertions, 608 were hospitalized for IUD-related complications (49% for bleeding requiring curettage and 20% with PID). IUD use for more than five years carried a relative risk of 3.9 for a severe episode when PID developed. Of the women who terminated use of their first IUD because of expulsions, pregnancy, or bleeding, 28% asked for reinsertion. Over the 15 years of IUD use, 853 pregnancies occurred with an IUD in situ. If the IUD was removed after conception, the pregnancy outcome did not differ from women without IUDs. If the IUD was not removed, there was an increased risk of spontaneous abortion, preterm labor, and intrauterine fetal infection. While the IUD users experienced the same risk of ectopic pregnancy as noncontraceptors, if the IUD user did become pregnant, their risk of ectopic pregnancy was twice as high as that faced by those who did not use IUDs. Duration of IUD use and type of IUD had no effect on time from removal to desired conception. This duration was increased, however, in women with a history of PID and in older women. Women over 40 tolerated the IUD better than younger women but as women approached 50, removals for bleeding became more frequent. In conclusion, the IUD is a very safe contraceptive agent and is well tolerated if users are selected carefully, are motivated, and receive help with side effects.^ieng

Use of echosonography to monitor uterine placement of intrauterine devices after immediate postpartum insertions.

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.

Severe pain at interval IUD insertion: a case-control analysis of patient risk factors.

This investigation, using a case-control analysis approach on an IUD data set from a less-developed country center, delineated four risk factors in patient characteristics that are associated with severe pain at interval IUD insertion. They are: higher education (greater than or equal to seven years), low-parity (1-2 live births), longer open interval (greater than or equal to 13 months) between the end of the last pregnancy and insertion, and non-breastfeeding at the time of insertion. Adjusted relative risks estimated by odds ratios are 2.1, 2.7, 2.7 and 5.0, respectively. For women with a combination of the above risk factors, they have a further increased (additive in nature) risk of suffering severe insertion pain. Similar analysis was also performed on a developed country center data set for which only the effect of education and parity could be studied; an odds ratio of 5.0 for nulliparity was obtained. The plausibility of these findings as well as their clinical and programmatic implications are discussed.

PIP: This investigation, using a case-control analysis approach on an intrauterine device (IUD) data set from a less-developed country center, delineated 4 risk factors in patient characteristics that are associated with severe pain at interval IUD insertion. They are: higher education ( or = 7 years) low parity (1-2 live births), longer open interval ( or = 13 months) between the end of the last pregnancy and insertion, and non-breast feeding at the time of insertion. Adjusted relative risks estimated by odds ratios are 2.1, 2.7, 2.7, and 5.0 respectively. For women with a combination of the above risk factors, they have a further increased (additive in nature) risk of suffering severe insertion pain. Similar analysis was also performed on a developed country center data set for which only the effect of education and parity could be studied; an odds ratio of 5.0 for nulliparity was obtained. Better educated women are probably less inhibited to complain of pain than less-educated women. A tighter uterine cervix and a smaller uterine cavity in women of low parity may account for IUD insertion pain. Postpartum involution of the uterus could explain pain upon insertion for women with a long open interval. These findings support the hypothesis that cervical stretching and direct endometrial pressure are probably the most important factors for IUD insertion pain.

Do insertion-related problems affect subsequent IUD performance?

This investigation compares the IUD performance of 372 women who had an insertion-related problem (most with moderate or severe pain) and 372 matched women who had no such problem; all women had interval insertion. A woman in the Problem Cohort and her matched counterpart in the Comparison Cohort were inserted with the same IUD type by the same insertor on the same day or on close dates. The six IUD types used by these women were Lippes Loop D, Copper-7, Copper T-200, Copper T-380 Ag, Multiload Copper 250 and Multiload Copper 375. Cumulative gross life-table rates of the pertinent events (accidental pregnancy, expulsion and medical removal for bleeding and pain), adjusted for age and parity, were calculated. Between the Problem Cohort and the Comparison Cohort, no differences were detected in the event rates that were of either statistical or practical significance. Results from this preliminary study suggest that the insertion-related problems usually encountered during interval insertion such as insertion pain, syncope and/or mild cervical laceration are not associated with an increased risk of IUD discontinuation due to pertinent events.

PIP: This study, based on data compiled by Family Health International, examined IUD performance in terms of problems related to insertion. The subjects included 2415 women from 6 centers in 5 countries who had had a Lippes Loop D, Copper T-200, Copper T-380 Ag, or Multiload 375 IUD inserted in 1976-84. Of these women, 165 (6.8%) had at least 1 insertion-related problem, including moderate or severe pain in 115, cervical laceration in 30, and syncope or other vasovagal reactions in 20. 150 of these cases were able to be matched with controls of similar age and parity with no insertion-related problems with the same device. Cases and controls were then compared in terms of rates of accidental pregnancy, expulsions, and medical removal in the 6 months postinsertion. The pregnancy rate at 6 months was 2.5% in cases vs. 1.6% in controls. The expulsion rate was 4.4% in cases vs. 1.5% in controls, and the medical removal rate was 2.3% in cases vs. 6.1% in controls. None of these differences was statistically significant. This lack of difference may be due to the experienced personnel at the study centers. In addition, since virtually all subjects had had at least 1 child, the study population was a low-risk one in terms of insertion-related problems. Moreover, there may not have been real differences between cases and controls, i.e., cases may have exaggerated the degree of insertion pain as moderate or severe when it was in fact mild. Although these results suggest that insertion-related problems are not associated with an increased risk of IUD termination, further studies with larger samples are needed to confirm this finding.

IUD insertion at cesarean section--the Chinese experience.

This review reports the experience of nine studies in Chinese maternity hospitals with insertions of an intrauterine device (IUD) at the time of cesarean section. In contrast to the usually high expulsion rates associated with immediate postpartum vaginal insertions, all nine studies reported low expulsion rates, thus resulting in high continuation rates with this procedure, comparable to those with interval insertions. This immediate post-cesarean section insertion procedure was also found to be safe. These findings are of programmatic importance for postpartum family planning delivery services and may eventually lead to an understanding of the expulsion mechanism in postpartum IUD contraception. Results of these reports have been synthesized in this review. Seven of these nine reports were originally in Chinese and were translated into English for the benefit of a broad international audience. Future research directions on this insertion procedure are also discussed.

Postpartum IUD insertions in Manila, Philippines.

In comparative IUD trials conducted in the Philippines, IUDs were inserted immediately postpartum (within ten minutes postplacenta). The first study was designed to compare the IPCS-52 mg (Intrauterine Progestasert Contraceptive System) IUD with the TCu200 when inserted either by hand or with an inserter. Follow-up continued for three years because the IPCS model was designed to release progesterone for this length of time. There was one suspected pregnancy for which the IUD was removed during the study period. The expulsion rates were higher in the IPCS groups than in the TCu groups (p less than or equal to 0.05) and they were higher in the hand insertion groups than in the inserter groups (p less than or equal to 0.05). The second study was a comparison of the Lippes Loop D and a Delta Loop, modified by the addition of three biodegradable suture projections (made of Ethicon #2 chromic material) on the upper arms of the device. The purpose of this modification was to lower the expulsion rates associated with postpartum insertions. The expulsion rates for these two devices were comparable. There were no difficulties during insertion in either study, and few complaints were reported at follow-up. These two studies demonstrated that immediate postpartum IUD insertion proved a safe, effective means of postpartum contraception.

Return to fertility after IUD removal for planned pregnancy.

The ability to conceive after discontinuing contraceptive practice is an important concern for women who have not completed their families. This paper focuses on 576 women who had their IUDs removed for planned pregnancy. The data from this study add further evidence that fertility subsequent to IUD removal is not impaired. Among these women followed-up, 94.3% conceived. The majority of these conceptions (55.9%) occurred during the first three months after IUD removal. In addition to analyzing conception rates, there were four factors that were considered in relationship to return to fertility. These were age at removal, duration of use, type of IUD (medicated vs non-medicated) and timing of insertion (interval vs postabortion). Age at removal was the only variable which seemed to influence conception rates.

Four-year follow-up of insertion of quinacrine hydrochloride pellets as a means of nonsurgical female sterilization.

Eighty-four women were admitted to a study in Baroda, India, designed for evaluation of the efficacy of three transcervical insertions of quinacrine hydrochloride pellets, each 1 month apart, in producing occlusion of the oviducts. A 4-year follow-up has been completed for 100% of the women. Three women became pregnant during the time between the first and third administrations. Of the 81 women remaining in the study after administrations were complete, 3 became pregnant during the 4-year follow-up period, which resulted in a cumulative life-table pregnancy rate of 3.7 at 48 months. The results of this study indicate that intrauterine insertion of quinacrine pellets can be a safe, effective nonsurgical sterilization procedure.

Evaluation of Copper I IUD's.

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.

Effects of breastfeeding on IUD performance.

The effect that lactation might have on intrauterine device (IUD) performance was investigated by using data from a series of multicenter clinical trials. Life-table methods were applied to compare breastfeeding and non-breastfeeding women with respect to IUD expulsion, accidental pregnancy, IUD removal for various reasons, and overall continuation of IUD use. Results indicate that breastfeeding does not increase the risk of expulsion or other events, whether the device is inserted immediately (within ten minutes) or more than 42 days after delivery. (Am J Public Health 1983; 73:384-388.)