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Effectiveness of breast self-examination prompts on oral contraceptive packaging.

BACKGROUND: The purpose of this study was to determine if a breast self-examination (BSE) "prompt" on oral contraceptive pill (OCP) packages would improve the frequency and timing of BSE among women who use OCPs. METHODS: Women between 13 and 40 years of age who were initiating, restarting, or continuing use of OCPs completed a baseline survey that assessed health behavior and practices. All received BSE education, and then were randomized to take either OCPs with a BSE prompt or regularly packaged OCPs (without BSE prompt) for three cycles. Three months later, subjects completed a follow-up survey that assessed BSE frequency and timing. A telephone survey of randomly selected subjects conducted 6 months after the baseline survey assessed BSE compliance after discontinuation of the prompt. RESULTS: Of the 907 subjects at baseline, 49.3% performed BSE monthly but only 24.5% performed BSE during the correct time of the menstrual cycle. Among subjects who never performed BSE prior to the study, 40.3% of prompt subjects and 36.4% of the education-only subjects began BSE by the 3-month survey. Among subjects who performed BSE less than once per month at baseline, 50.9% of prompt subjects and 45.5% of education-only subjects increased the frequency of BSEs to a monthly basis by the 3-month survey. More women performed BSE during the correct time of the menstrual cycle at the 3 month follow-up survey (68.1% prompt, 62.2% education only) and 6-month survey (57.4% prompt, 48.9% education only) when compared with the baseline survey (24.7% prompt, 24.1% education only). Ninety-one percent of women in this study expressed a preference for a BSE prompt on OCP packaging. CONCLUSIONS: An increased frequency of BSE was observed when women were exposed to an OCP package prompt, particularly for women who at baseline were already partially compliant with performing monthly BSE. A small but significant improvement was observed for correct BSE timing and this effect continued after the prompt was removed, although at a reduced level. The innovative BSE prompt was overwhelmingly well received by women in this study.

Adolescent↗

Patient satisfaction with a levonorgestrel-releasing contraceptive implant. Reasons for and patterns of removal.

OBJECTIVE: To investigate the experience of the users of a levonorgestrel-releasing contraceptive implant (Nor-plant) and reasons for early removal. STUDY DESIGN: Two hundred fifty-one women who had Norplant placed through the Ohio State University Department of Obstetrics and Gynecology were sent a questionnaire that included general demographic questions and questions regarding preplacement education; reasons for choosing Norplant; problems experienced due to Norplant; reasons for removal, if applicable; and overall satisfaction. RESULTS: One hundred eleven questionnaires (44%) were completed and analyzed. Twenty-four (21.6%) of patients had Norplant removed, 32 (28.8%) planned on early removal, and 55 (49.5%) desired continued use. Ninety-eight percent of women who planned continued use of Norplant had received reading material as part of their preplacement counseling and 95% felt adequately counseled. This is significantly higher than women who had Norplant removed or planned on early removal. Convenience, problems with other contraceptive methods and effectiveness were the most important reasons why patients chose Norplant. Menstrual changes were the most common side effect, experienced by 80% of all women in the study. Weight gain, headache, mood changes, mastalgia and acne were also frequently reported. Women who had Norplant removed were significantly more likely to have experienced dizziness when compared to women desiring continued use. Women planning early removal were also more likely to have experienced dizziness in addition to acne, headache, hair loss and other side effects. Menstrual irregularities, followed by mood changes and headaches, were the most important side effects associated with early Norplant removal. Overall, 68% of users were at least somewhat satisfied with Norplant. CONCLUSION: Norplant contraception was a satisfactory form of birth control for the majority of patients in the study despite the frequent occurrence of side effects. Reading material regarding benefits and side effects of Norplant is an important aspect of patient counseling and may improve long-term use of Norplant.

Adolescent↗

Gender and blood pressure.

The prevalence, impact, and control of hypertension differ between the sexes in the US population. In addition, pregnancy, oral contraceptive use, and menopausal hormone therapy may influence blood pressure regulation in ways that have therapeutic implications for some women. Whether gender should be a significant consideration in the choice of individual antihypertensive drugs continues to be a topic of intense interest and debate. This brief review will discuss recent findings that bear on considerations of gender in the management of hypertension, particularly among older women.

Antihypertensive Agents↗

Gynecologic and obstetric issues in the adolescent with heart disease.

It is necessary to adopt a proactive, prevention-based strategy for addressing gynecologic and obstetric issues in the adolescent with heart disease. Pregnancy carries known cardiovascular alterations, manifestations and risks. The nature of the underlying cardiac disease needs to be considered in preconception counseling and in the prevention of pregnancy. Specific risks of oral contraceptive methods must be considered as well. Estrogen-based oral contraceptives may confer risks of thromboembolic phenomenon, whereas progesterone-based agents may be associated with increased risk of bleeding. Medical termination of pregnancy may pose risks to the young woman with cyanotic heart disease or pulmonary hypertension. Full prepregnancy evaluation helps to ensure a good outcome for both mother and baby. There are risks of continuing specific cardiovascular medications during pregnancy; however, certain medications are continued to safeguard maternal health. This is particularly problematic in the patient who must remain on anticoagulation.

Adolescent↗

Asian workshop recommends injectables.

Injectable contraceptives are now in use in over 65 countries, including 15 developed nations. At the 1st Asian Regional Workshop on Injectable Contraceptives, held in Thailand in May, this fact was underlined and the conclusion reached that it was time that other countries should review the acceptability of and need for injectable contraceptives in the context of their own national family planning programs. Over 50 people from 11 countries, including Bangladesh, India, Indonesia, the Philippines, Sri Lanka, and Thailand, took part. The workshop was also attended by IPPF's deputy medical director, Dr. Pramilla Senanayake. The largest clinical experience in the use of injectable contraceptives is in Asia, and the participants of the workshop were able to meet 10 of the Thai women who had had the injectable, Depo-Provera, continuously for over 10 years. These women had not missed a single injection, and had had no serious side effects, nor any unwanted pregnancies during this time. In a discussion on the recent decision of the U.S. Food and Drug Administration (FDA) to refuse a license for Depo-Provera in the U.S., it was pointed out that on 2 successive occasions Depo-Provera had been recommended for approval to the FDA by its own Obstetric and Gynecological Advisory Committee. (The membership of this advisory committee was made up of U.S. experts in obstetrics and gynecology.) Medical data were considered which showed that the return of fertility with Depo-Provera was comparable to that with oral contraceptives or IUDs, and method failure extremely low. On the evidence now available the workshop agreed that on the grounds of safety, exceptional use-effectiveness, and acceptability, injectable contraceptives had a valuable role to play in family planning. No serious adverse effects had been reported, freedom from metabolic effects was important, and earlier concern about the return of fertility after discontinuation had been dispelled. The current evidence on the safety of injectables did not indicate that this method would be less safe than oral contraceptives or IUDs.

Asia↗

Hypertension, renal vein thrombosis and renal failure (occurring in a patient on an oral contraceptive agent).

A case of accelerated hypertension leading to renal failure in a young woman taking an oral contraceptive agent is described. During the course of her disease the left kidney was documented to decrease in size. Renal vein plasma renin activity was found to be elevated on the left in the absence of renal artery stenosis. Left nephrectomy, prompted by continuing poor blood pressure control, resulted in amelioration of the hypertension. Left renal vein thrombosis was found at surgery. It is suggested that renal vein thrombosis was a contributing factor to this patient's accelerated hypertension and may represent an unusual thrombotic complication of oral contraceptives.

Acute Kidney Injury↗

Mortality and fertility control.

The authors present a continuation of the thesis suggesting that the most rational procedure for regulating fertility is a perfectly safe, even though not completely effective, contraceptive method combined with safe methods for terminating pregnancy when the contraceptive fails. This analysis demonstrates that, compared with the risk of death from pregnancy and childbirth, major reversible methods of fertility control--the pill, IUDs, condoms, and diaphragms--and abortion are associated with very low levels of mortality. The exception to this statement is pill use after age 40 by women who smoke. This analysis also confirms the very low mortality associated with using the condom and diaphragm with early induced abortion as a backup to terminate pregnancies resulting from contraceptive failures.

Abortion, Induced↗

Chronic low-dose antiprogestin impairs preimplantation embryogenesis, but not oocyte nuclear maturation or fertilization in rhesus monkeys.

Continual administration of low doses of the antiprogestin ZK137316 permits ovarian/menstrual cyclicity, but prevents pregnancy in female rhesus monkeys. The sites of contraceptive action remain unknown. This study determined whether chronic, low-dose antiprogestin exposure during follicular development impairs oocyte maturation in vivo, as well as fertilization and preimplantation embryogenesis in vitro. Adult, female rhesus monkeys exhibiting normal menstrual cycles received vehicle (n=9) or 0.03 mg ZK137316 (n=8)/kg body weight i.m. daily for 3 months. Controlled ovarian stimulation with recombinant gonadotropins was initiated in the 3rd month. Oocytes collected from preovulatory follicles were evaluated for nuclear maturity and inseminated in vitro. Preimplantation embryonic development was monitored in vitro. The total number of oocytes and percentage collected at each nuclear stage were similar in both groups. More (P<0.05) atretic oocytes were recovered following antiprogestin relative to vehicle treatment. Fertilization rates and percentages of embryos that progressed to the morula stage were similar between groups, but antiprogestin-treated females exhibited less (P<0.05) normal cleavage. Embryonic development was accelerated by 1 day (P<0.05) from the 16-cell to the morula stage in the antiprogestin group relative to vehicle. Despite this, the majority of embryos became blastocysts within 6 days in vitro in the antiprogestin group, but fewer expanded (P=0.09) and hatched (P<0.05) compared to vehicle. During in vivo treatment with chronic, low-dose antiprogestin, oocytes retained their ability to resume and complete meiosis as well as fertilize following insemination in vitro. However, preimplantation embryogenesis in vitro was impaired, particularly during the later stages of blastocyst development. Thus, antiprogestin exposure during follicular development altered oocyte functions that are critical for normal preimplantation embryogenesis; this may contribute to pregnancy prevention.

Animals↗

Unsafe abortion: an avoidable tragedy.

An estimated 60 000-70 000 women die annually from complications of unsafe abortion and hundreds of thousands more suffer long-term consequences which include chronic pelvic pain and infertility. The reasons for the continuing high incidence of unwanted pregnancy leading to unsafe abortion include lack of access to, or misuse of and misinformation about, effective contraceptive methods, coerced sex which prohibits women from protecting themselves, and contraceptive failure. Unsafe abortion is closely associated with restrictive legal environments and administrative and policy barriers hampering access to existing services. Vacuum aspiration and medical methods combining mifepristone and a prostaglandin for early abortion are simple and safe. For second trimester abortion, the main choices are repeat doses of prostaglandin with or without prior mifepristone, and dilatation and evacuation by experienced providers. Strategies for preventing unsafe abortion include: upgrading providers' skills; further development of medical methods for pregnancy termination and their introduction into national programmes; improving the quality of contraceptive and abortion services; and improving partner communication.

Abortifacient Agents↗

Fertility status among women treated for aggressive non-Hodgkin's lymphoma.

In young women treated for intermediate-high-grade non-Hodgkin's lymphoma with CHOP (cyclophosphamide, adriamycin, oncovine and prednisone), there is insufficient data concerning gonadotoxicity or the need for fertility-preserving measures. The aim of the present study was to evaluate the fertility status in the first complete remission of women who were treated for aggressive non-Hodgkin's lymphoma. A cohort of 36 women with aggressive non-Hodgkin's lymphoma in first remission, who were treated in five university-affiliated hospitals in Israel, was evaluated. All women were aged younger than 40 years at diagnosis and received frontline protocols, including cyclophosphamide and adriamycin, mostly CHOP. Menstrual cycle characteristics, as well as pregnancies before the diagnosis, during treatment and in first complete remission, were evaluated. The patients' mean age at the diagnosis was 28 +/- 7 years (range 17 - 40 years). All patients were treated with chemotherapy, although 10 patients received additional radiotherapy. Follow-up time at first complete remission was 84 +/- 48 months. Before diagnosis, all patients had menstrual cycles, which were regular in 31 (86%). Three patients received gonadtropin-releasing hormone analogs, whereas nine received contraceptive pills together with cytotoxic treatment. During treatment, 18 patients (50%) had amenorrhea, six (17%) had irregular menstrual cycles, and 12 (33%) continued their regular cycles. All but two women resumed menses in the first complete remission, and these were regular in 22 (61%) patients. In 63% of patients, the menstrual cycle recovered within 3 months of the discontinuation of chemotherapy. Eighteen patients (50%) became pregnant during the first complete remission. There was no significant difference between those patients who received fertility-preserving measures versus the remainder concerning regular menstrual cycles recovery or pregnancies. The two patients who developed amenorrhea were 40 years old at the time of diagnosis. In conclusion, the rate of gonadal dysfunction is very low among young, CHOP treated, non-Hodgkin's lymphoma female patients. Fertility-preserving techniques are not needed for women aged younger than 40 years and should probably be reserved for those who are at high risk for gonadal toxicity.

Adolescent↗

Venous thromboembolism during pregnancy is not associated with persistent elevated activated protein C (APC) sensitivity ratio based on the endogenous thrombin potential.

Women who are using oral contraceptives can acquire APC resistance, measured by the effect of APC on the endogenous thrombin potential (ETP). The objective of our study was to examine whether persistentAPC resistance determined with an ETP-based normalized APC sensitivity ratio (nAPCsr) is a risk marker for venous thromboembolism in women with pregnancy-associated thromboembolism. We determined the activities of antithrombin, protein C, protein S, and performed a genetic analysis of factor V Leiden G1691A, prothrombin mutation G20210A, and methylenetetrahydrofolate reductase mutation (MTHFR C677T) in 65 women with venous thromboembolism during pregnancy or the puerperium and in 114 normal women. A significantly (p<0.05) higher nAPCsr was present in normal women using hormones, in younger women (<or=45 yrs), and in women with carrier status of factorV Leiden. In normal women without factor V Leiden a significant (p<0.05) negative correlation of nAPCsr with age (r=-0.39), antithrombin activity (r=-0.38), protein S activity (r=-0.26), and a significant positive correlation with hormone intake (r=0.36) was present. nAPCsr is influenced by several coagulation parameters, which are modified by the use of oral contraceptives. Consequently, a multivariate analysis of our data did not show a significant association of nAPCsr to venous thromboembolism, neither as a continuous variable (odds ratio 0.8, 95% CI 0.6-1.1, p=0.10) nor using a cutoff value (nAPCsr cut-off 3.1: odds ratio 1.2, 95% CI 0.3-5.3, p=0.77). Our study demonstrates that nAPCsr is not a risk marker for pregnancy-associated venous thromboembolism.

Activated Protein C Resistance↗

A review of teen-tot programs: comprehensive clinical care for young parents and their children.

Comprehensive clinical programs for teenage mothers and their children, also known as teen-tot programs, have been a promising intervention to improve outcomes of teenage childbearing and parenting. However, much remains unknown regarding the efficacy of such programs. We reviewed four published evaluations of programs that provided medical care, counseling, contraception, guidance for parenting, and assistance with staying in school. The evaluations reported moderate success in preventing repeat pregnancies, helping teen mothers continue their education, and improving teen and infant health over 6 to 18 months. However, the evaluations had limitations that may have reduced or accentuated observed effectiveness. Teen-tot programs will continue to face the challenges of sustaining adequate long-term interventions and evaluations, and reducing the high attrition rate among program participants. It is concluded that increased support and funding for teen-tot programs and more complete evaluations are warranted.

Adolescent↗

Advances in the management of endometrial adenocarcinoma. A review.

Endometrial adenocarcinoma is the most common and curable gynecologic neoplasm; the five-year survival for women with surgical stage I disease ranges from 83% to 93%; stage II, 73%; stage III, 52%; and stage IV, 27%. The absence of an asymptomatic latency phase amenable to detection through screening and the already excellent cure rates seen with early-stage disease have precluded the need for endometrial cancer screening programs. Adenocarcinomas constitute 97% of endometrial cancers, with endometrioid the most common histologic subtype. Two different pathways of endometrial carcinogenesis exist. One arises in a background of estrogen excess, giving rise to atypical hyperplasia as the malignant precursor of the more common endometrioid adenocarcinomas. The use of oral contraceptives has consistently been shown to decrease the risk of developing endometrial carcinoma via this pathway, with 12 months or more of continuous use decreasing the lifetime risk by 40-50%. The alternate pathway of endometrial carcinogenesis represents malignant transformation of atrophic endometrium and proceeds through endometrial intraepithelial carcinoma as the malignant precursor of the more virulent serous papillary and clear cell endometrial adenocarcinomas. The staging of endometrial cancer (according to the International Federation of Obstetrics and Gynecology) is surgical. Recent studies suggest a therapeutic benefit associated with extensive retroperitoneal lymph node evaluation to determine the disease extent and thereby more effectively direct potentially life-saving adjuvant therapy. Adjuvant radiation therapy, known to have survival benefit in advanced-stage disease, may also have survival benefit in intermediate-risk surgical stage I disease on the basis of results recently released from a Gynecologic Oncology Group study. The use of radiation therapy, systemic chemotherapy and hormonal therapy, alone or in combination, is recommended for primary advanced and recurrent disease.

Adenocarcinoma↗

Research on methods of fertility regulation.

Researchers continue to discover improved methods of fertility regulation. The primary goal has been to find methods that are as effective as oral contraceptives and the intrauterine device, but that have fewer side effects. Ease of administration and long-term usage are highly desirable secondary goals. Hormonal methods (various pills, implants, vaginal rings, and injectables), new intrauterine devices, and other methods under study are discussed.

Contraception↗

Trends in fertility, family size preferences, and family planning practice: Taiwan, 1961-76.

A series of six sample surveys and vital statistics are used to analyze major reproductive trends for 1961-76 in Taiwan. Fertility fell rapidly during 1961-70 as a result of adoption of contraception and rising age at marriage, while there was little change in preferred family size. Between 1970 and 1976 the practice of contraception reached high levels in all social strata, and preferred family size and fertility both declined rapidly. Practice of contraception for spacing births increased considerably after 1970. These changes occurred while many traditional familial values, including strong son preference, persisted. A continuation of the decline in fertility is predicted.

Adolescent↗

The role of family planning in recent rapid fertility declines in developing countries.

World Fertility Survey data for ten developing countries are used to examine the respective roles of development and family planning in influencing the regulation of fertility. The findings show that high proportions of women at all socioeconomic levels in the countries studied wanted no more children, including large proportions among rural, poor, and uneducated women with few children. The data also show that despite the limitations of underdevelopment, in countries with strong family planning programs knowledge and use of contraception was high. These findings confirm that there is a large unmet demand for family planning and point to the importance of continued allocation of funds to support service programs.

Adolescent↗

Maternal implications of gestational diabetes.

Gestational diabetes encompasses a variable spectrum of decompensated glucose tolerance, with a substantial risk for developing future NIDDM. Several easily identifiable risk factors for subsequent diabetes have been identified, notably elevated fasting glucose levels during pregnancy, early diagnosis of gestational diabetes, and obesity. By continuing to identify independent risk factors during pregnancy and in the puerperium, we can develop better intervention programs and medical therapy to prevent or delay the onset of diabetes. Glucose tolerance testing in the postpartum period followed up by annual glucose surveillance for diabetes should be performed in all women with prior GDM. They should be actively educated about their high risk of diabetes and strongly encouraged to continue their diabetes and strongly encouraged to continue their diabetic diet, achieve an ideal body weight, and implement an exercise program. Combining such a program of preventive care with contraceptive visits contributes to a complete health care program for women with prior GDM during their reproductive years.

Diabetes, Gestational↗

Studies of a controlled-release microcapsule formulation of an LH-RH agonist (D-Trp-6-LH-RH) in the rhesus monkey menstrual cycle.

It has been shown that continuous administration of LH-RH agonists inhibits ovulation in many species, including human and nonhuman primates. However, the need of daily injections or intranasal application of the LH-RH agonists makes this contraceptive approach impractical. In addition, due to the repeated daily administration of the LH-RH analogues and their bioavailability, serum levels of gonadotropins and estradiol present wide variations and are often associated with irregular bleeding and/or endometrial hyperplasia. This experiment was designed to study the effects on ovulation and the hormonal profile during the rhesus monkey menstrual cycle of a system that continuously delivers a potent agonist of LH-RH (D-Trp-6-LH-RH encapsulated in poly [DL-lactide-co-glycolide]). Subjects were divided into two groups: On day 1 of the cycle, monkeys received a single subcutaneous injection of microcapsules containing D-Trp-6-LH-RH at a release rate of 13.6 micrograms/day (Group 1) or placebo microcapsules (Group 2). Ovulation dates were significantly delayed in animals from Group 1 (50 +/- 3 days) as compared to those in group 2 (20 +/- 2 days). Luteal phases following ovulation were normal in animals of both groups, as determined by length and serum progesterone levels. No significant differences on baseline levels of FSH and LH were observed between the two groups of animals. Post-treatment cycles were ovulatory and presented normal luteal phases and hormone concentrations as compared to the non-treated animals of our colony. The present data show for the first time that a controlled-release microcapsule formulation that delivers an agonist of LH-RH can effectively suppress ovulation when injected in a single dose in non-human primates.

Animals↗