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Risk of ovulation during lactation.

60 breastfeeding mothers in Baltimore and 41 in Manila recorded their infant feeding patterns daily, and gave additional information at weekly interviews. Ovarian activity was monitored by assays for hormone metabolites in daily urine samples. On average, women in Baltimore breastfed less often but for longer at each feed than women in Manila, and the mean times until ovulation were 27 and 38 weeks post partum. 41% of first ovulations had luteal phase defects. Anovular first menses were common (45.1%) during the first 6 months post partum but the rate fell greatly thereafter. The risk of ovulation was reduced by a higher frequency of breastfeeds, longer duration of each feed, and less supplementary feeding. During the first 6 months post partum, amenorrhoeic women had low risks of ovulation (below 10%) with partial breastfeeding, and exclusive breastfeeding reduced the risk to 1-5% with either frequent short feeds or infrequent longer feeds. However, if the woman started menstruating before 6 months post partum, or if she continued breastfeeding beyond 6 months, the risk of ovulation rose, and contraception would be needed.

Amenorrhea↗

Long-term recall of time-to-pregnancy.

OBJECTIVE: To validate two versions of a short self-completion questionnaire on time-to-pregnancy. DESIGN: Information from the questionnaire was compared with concurrently collected data from the same individuals. POPULATION: Questionnaires were sent to 1,647 women who continue to be followed up by the Oxford Family Planning Association Contraceptive Study. Replies were received from 1,498, a response rate of 91.0%. Successful matching was achieved with 1,392 pregnancies that met the study criteria and that had values of time-to-pregnancy in both data sources. Median recall time was 14 years (interquartile range, 11 to 16 years). MAIN OUTCOME MEASURES: At the group level, the frequency distributions of time-to-pregnancy from the two sources are presented as cumulative percentages. At the individual level, the distribution of discrepancies between the sources is tabulated separately for each value of time-to-pregnancy, and accuracy of detection of clinical subfertility is presented (sensitivity and specificity). RESULTS: At the group level, remarkably good agreement was found between the two sources of information. Digit preference was present to a limited degree. There were no important differences between the two questionnaire versions. At the individual level, some misclassification was evident. For the detection of clinical infertility, sensitivity was 79.9% and specificity was 94.9%. CONCLUSIONS: Short, self-completion questionnaires are remarkably accurate for assessing time-to-pregnancy at a group level. Individual-level misclassification is frequent, but detection of clinical subfertility is fairly accurate.

Adult↗

Measuring the intensity of pregnancy planning effort.

This study validated a measure of pregnancy planning effort based on Miller's conceptual framework in two clinical settings. The questionnaire's main items deal with general behaviour with regard to pregnancy, timing and proception (proception being the reverse of contraception). Values for these three items are added to yield a continuous score ranging from 0 to 12. The study population comprised 448 women of different cultural backgrounds recruited in prenatal, fertility and family planning clinics in Quebec and North Carolina. The results indicate that the internal consistency between the three items pertaining to pregnancy planning was excellent (Cronbach's alpha of 0.83). Test-retest reliability after a 4-week interval was excellent, with an intraclass correlation coefficient of 0.86 for the planning score. The planning score median for women attending family planning clinics (1.00) was significantly lower than that for those recruited in fertility clinics (11.00), confirming the discriminant ability of the instrument. Path analysis shows that the conceptual model corroborates the observed data and explains 53% of the pregnancy planning variability. In conclusion, this is the first questionnaire specifically designed to assess the intensity of pregnancy planning effort, a potentially important variable in epidemiological studies and clinical practice.

Family Planning Services↗

[An integrated concept for contraception counseling and HIV prevention for young women: the Project Nécessaire].

PURPOSE: The aim of this study was to evaluate the effectiveness of the innovative project "Nécessaire" on sexual and reproductive health promotion. "Nécessaire" was developed for young women and carried out in the German-speaking part of Switzerland. The concept consisted of giving theoretical information in a brochure suitable for young women in its design combined with several items (such as condom, chewing gum, sticker) in a spongebag. METHOD: Young women (n = 183) as well as professionals (n = 154) were asked to give their opinion on the "Necessaire" by filling in a semi-structured questionnaire. In addition, the product ordering was monitored over 7 months, in order to examine the use of the product by various institutions. RESULTS: On the whole, the young women praised the product. They especially liked the brochure, which was made up like a diary written by a young woman called Rosa. According to their answers the combination of information and useful items stimulated the reflection on topics like sexuality, love, and prevention of sexually transmitted diseases. Critical voices pointed out the need for interventions aimed at young men, in order to make them more aware of their responsibility in contraception, HIV prevention and partnerships. The professionals generally would like to continue using the product in their work with young women. Many of them asked for more accompanying material with practical ideas for using the product. A similar product for young men and foreign youngsters was often asked for. The monitoring of the product ordering showed that schools and institutions such as youth centres evinced the greatest interest in the product. This contrasted with the results of a feasibility study conducted in advance. Although medical and advice centres indicated a need for a product to support professionals counselling young women, these institutions ordered relatively few kits. CONCLUSION: Generally speaking the "Nécessaire" was well received by young women as well as by professionals. It not only informs on sexual health but also promotes preventive behaviour in daily life. The product was not used as an aid for counselling young women as much as was intended. It is suggested to promote the Nécessaire's use by taking specific measures like developing written material with practical ideas for professionals. In the case of developing a similar product for young men and migrants, their specific backgrounds and cultures should be taken into account and the material adapted accordingly.

Adolescent↗

Experience with Implanon in a northeast London family planning clinic.

AIM: The primary objective of the study was to evaluate the continuation rates of a relatively new long-acting method of contraception, Implanon. The secondary objective was to study discontinuations related to bleeding problems and their management. METHOD: A retrospective review of records of women fitted with Implanon was undertaken during February 2000--January 2003. RESULTS: Results from the secondary objective will be the subject of a separate communication. Of the 147 implants fitted, 132 records could be retrieved; of these, 97% of the women had pre-insertion counselling by the clinician. The most common indications for Implanon usage were choice of a long-acting method, unhappy experience with other contraceptive methods and suboptimal compliance with contraceptive pills and injectables. The median age of fitting was 25 years and 36% of the women were nulliparous. No problems were experienced with fitting or removal of implants. Twenty (15%) women were lost to follow-up. Twenty-two implants were removed by the end of the study period, with 12 (60%) removals attributed to prolonged heavy/light bleeding. There were no known pregnancies during the study. Given that 15% of the women could not be followed up or contacted, the assumed lifetimes of Implanon using the Kaplan-Meier method are 0.90 (95% confidence interval 0.82-0.95) at 12 months, 0.80 (0.67-0.88) at 24 months and 0.75 (0.58-0.85) at 35 months. The confirmed lifetimes are 0.84 (0.71-0.91) at 12 months, 0.63 (0.42-0.78) at 24 months and 0.53 (0.28-0.73) at 35 months. CONCLUSION: Although not free of side-effects, Implanon can be a good choice for women who are properly informed and counselled and seek long-term 'forgettable' contraception.

Adult↗

A time to pregnancy questionnaire designed for long term recall: validity in Oxford, England.

STUDY OBJECTIVE: To establish the degree of validity of data on time to pregnancy, derived retrospectively using a short questionnaire. DESIGN: Information from the questionnaire was compared with data that had been collected concurrently from the same individuals. SETTING AND PARTICIPANTS: Questionnaires were mailed to 1647 women who continue to be followed up by the Oxford Family Planning Association contraceptive study, and a further 424 were approached for personal interview. Response rates were 91% and 79% respectively. MAIN RESULTS: Matching was successful in 91% of pregnancies. Median recall time was 14 years (interquartile range, 11-16 years). At the group level, remarkably good agreement was found between the two sources of information, presented as cumulative percentage distributions of live births. The findings were at least as good with longer recall (> 14 years) as with shorter recall. Digit performance was present to a limited degree. At the individual level, some misclassification was evident, which has implications for statistical power. For detection of clinical infertility (no conception within 12 months), the sensitivity was in the range 67%-91%, and the specificity was 92%-96%. Variations with format, duration of recall, age at delivery, year of birth, parity, social class, smoking habit, last contraceptive method, and outcome (live birth or not) were generally small, and were not statistically significant. CONCLUSIONS: Time to pregnancy is a sensitive way of assessing reproductive function in either sex. Valid data at a group level can be derived retrospectively, with a long duration of recall, using a short questionnaire.

Adult↗

Minireview: genetic models for the study of gonadotropin actions.

Fertility in both sexes relies on complex physiological and molecular processes with many levels of regulation, and our ability to alter the mammalian genome using transgenic technology has greatly enhanced our understanding of these processes. There are numerous commonalities in human and mouse physiology, and the list of mouse models recapitulating recognized and idiopathic human reproductive defects is growing at an ever-increasing rate. In this review, we focus on genetic models of gonadotropin actions, summarizing features of transgenic mice that phenocopy defects in gonadotropin production and gonadotropin receptor responses seen in patients. In addition, we provide examples of mouse models with genetic alterations influencing pituitary FSH and LH production and their effects. These include: 1) transgenic mice with aberrations in steroid hormone, inhibin, and activin feedback pathways; 2) knockouts that demonstrate specific in vivo functions of pituitary transcription factors; and 3) models with alterations in other pituitary hormones, IGF-1, and leptin signaling pathways, which affect both the central and peripheral endocrine axis. What we have to learn from these and other models will continue to revise our conceptions of physiology, identify new targets for contraception, and improve our tools for understanding, diagnosing, and treating cases of human endocrinopathies and pathologies of the reproductive tissues.

Animals↗

Emotional reaction to sterilization.

Ninety-four patients sterilized by tubal occlusion were interviewed at the time of hospitalization for surgery and followed at scheduled intervals for a 2-year period. There were no serious problems, medical or psychologic, and all but 3 patients were pleased and satisfied at the end of 2 years. There were no technical failures. Psychosomatic symptoms do develop. They are more prominent and persist longer in the younger age group. Patients having these symptoms are those who had difficulty with contraceptive technics, have a limited understanding of the sterilization procedure, and continue to question its permanency. The need for preoperative evaluation and counseling is emphasized.

Adolescent↗

Squamous metaplasia of the endometrium. Endometrial response to intrauterine presence of fibroblast-carrying Ivalon sponge.

Squamous metaplasia of the endometrium was detected in 3 women out of ten in which fibroblast-carrying Ivalon sponge (produced by implanting the sponge subcutaneously for 6 to 8 weeks) was inserted into the uterus following dilatation and curettage. The experiments were carried out in view of previous successful similar procedures in rabbits to produce fibroblastic bridges inside the uterus, and to avoid the patients from undergoing major surgery (hysterectomy) if possible, and at the same time to use the experiment as a model of contraception procedure. Since no improvement was experienced by the patients, which continued to have excessive blood loss, hysterectomies were performed at a later date, and the specimens were thoroughly examined. The possible effect of the Ivalon sponge (acting as IUCD) on the endometrium is discussed.

Adult↗

Reproductive health counseling at pregnancy testing: a pilot study.

OBJECTIVES: To pilot brief reproductive health counseling for women obtaining pregnancy testing in a managed-care setting who did not desire pregnancy. METHODS: Women received counseling, access to contraception and a booster call at 2 weeks. Changes in contraceptive behavior were evaluated. RESULTS: Of 85 women who completed counseling, 58 (68%) completed follow-up. Participants reported that counseling was useful at baseline (94%) and follow-up (83%). The staff found the intervention important (100%) and implementation feasible (100%). Forty-one percent of participants improved their use of contraception (from no use or from less effective use to more effective use). Twenty-nine percent continued highly effective use and 9% recessed from highly effective use. Of 22 participants with risk of sexually transmitted disease, 3 (14%) began using condoms consistently, while 1 (5%) continued using condoms consistently. CONCLUSIONS: Counseling at pregnancy testing was well accepted by the staff and participants. Observed behavioral changes suggest that this intervention may be effective in increasing effective use of contraception.

Adolescent↗

Some methodological considerations of a progestin-only oral contraceptive study from a programmatic perspective.

Among the limited number of reports on progestin-oral contraceptives (POCs), noncomparative studies conducted at family planning clinics have been the most often reported. This research trend will probably continue. Generally, noncomparative studies address a number of practical issues on POC use, and such studies have made important contributions to the understanding of this contraceptive modality. However, some studies have presented results that are either difficult to extrapolate for potential users or conflict with other findings. This article reviews several studies and suggests ways to improve the study methodology. Well-conceived, -executed, and -analyzed noncomparative studies can cost-effectively address a number of practical issues of POC use that have not been adequately addressed. Additional topics with programmatic utility, such as the effect of local background variables on POC acceptability, and the place of POCs in the ever-increasing contraceptive spectrum, are also discussed.

Adult↗

The long-term demographic role of community-based family planning in rural Bangladesh.

Experimental studies demonstrating the effectiveness of nonclinical distribution of contraceptives are typically conducted in settings where contraceptive use is low and unmet need is extensive. Determining the long-term role of active outreach programs after initial demand is met represents an increasingly important policy issue in Asia, where contraceptive prevalence is high and fixed service points are conveniently available. This article examines the long-term rationale for household family planning in Bangladesh-where growing use of contraceptives, rapid fertility decline, and normative change in reproductive preferences are in progress, bringing into question the rationale for large-scale deployment of paid outreach workers. Longitudinal data are analyzed that record outreach encounters and contraceptive use dynamics in a large rural population. Findings demonstrate that outreach has a continuing impact on program effectiveness, even after a decade of household visitation. The policy implications of this finding are reviewed.

Adult↗

The prevention of breast cancer through reduced ovarian steroid exposure.

Analysis of epidemiologic data on cancers of the breast, ovary and endometrium; the effects of endogenous hormones on cell proliferation; and current carcinogenesis concepts, suggest that hormonal contraceptives can be developed that will reduce lifetime risk of all 3 cancers. The 'unopposed-estrogen hypothesis' accounts for endometrial cancer risk factors. Ovarian cancer risk is closely related to the total frequency of ovulation. The risk of breast cancer can be explained by an 'estrogen-plus-progestogen hypothesis'. On the basis of this analysis an hormonal contraceptive regimen has been developed consisting of a gonadotropin-releasing hormone agonist (GnRHA) plus continuous low-dose add-back estrogen and a short course of progestogen every fourth month. The total dose of add-back estrogen is estimated to be approximately 38% that in present-day low-dose combination-type oral contraceptives (COCs). The total dose of progestogen is approximately 15% that in COCs. This regimen prevents ovulation and should thus reduce ovarian cancer risk. It also reduces the exposure of the endometrium to unopposed estrogen, and the exposure of the breast to estrogen-plus-progestogen. It is estimated that use of such a regimen for 10 years will only reduce lifetime risk of endometrial cancer by one-sixth, but lifetime risk of ovarian cancer is estimated to be reduced by two-thirds, and lifetime risk of breast cancer is estimated to be reduced by one-half.

Breast Neoplasms↗

The levonorgestrel intrauterine system in contraception.

The levonorgestrel intrauterine system (LNG IUS) releases 20 microg/24 h of levonorgestrel from a polymer cylinder mounted on a T-shaped frame and covered with a release rate-controlling membrane. It is approved for 5-year use. The most outstanding features of LNG IUS are its high contraceptive efficacy and reduction of menstrual blood flow. No single mode of action can account for its contraceptive efficacy. The endometrium becomes thin and inactive, and the cervical mucus turns scanty and viscous. Although ovulation may be disturbed to some degree, estradiol production continues normally. The Pearl index for LNG IUS from large clinical trials is 0.1. Extrauterine pregnancies occur in 1 in 5000 users per year. Both the volume of menstrual blood loss and the number of bleeding days are reduced. During the first year of use, 20% of women become amenorrheic. There is an initial increase in the mean number of bleeding and spotting days, but in 3 to 6 months the number of bleeding and spotting days is the same as observed in copper IUD-users. The variation between individuals is wide and unpredictable. There are also additional health benefits secondary to the inactivation of the endometrium: increased hemoglobin, decreased dysmenorrhea, a possible decrease in pelvic inflammatory disease. LNG IUS may also decrease the growth of fibroids. LNG IUS is well accepted by users, with typical annual continuation rates above 80% in clinical studies.

Contraceptive Agents, Female↗

[Long acting hormonal contraception].

Long-acting hormonal contraception has been widely accepted in different cultures, where the use of injectables and implants is preferred over other methods of fertility control. The administration of synthetic progestogens in combination with estrogens as injectables suppresses ovulation, allowing the control of the endometrial bleeding too. The use of injectables containing only progesterone constitutes a 2 to 6 months contraceptive method with high effectiveness and easy administration, although its major disadvantage is the alteration of the endometrial bleeding pattern, which is the most common cause of discontinuation. The group of long-acting injectables includes the development of microencapsulated steroids, whose structure gives them the property of maintaining controlled liberation of the drug. Recently subdermal contraceptive implants (Norplant) have appeared, based on the subcutaneous sustained liberation of levonorgestrel. The daily drug dose is enough to inhibit ovulation in the initial months of use and modifies the cervical mucus in the subsequent months. Norplant has been shown to be efficient in preventing pregnancy, but main secondary effect is bleeding pattern disturbance during the menstrual cycle. The Capronor constitutes a new system of contraceptive implant which is different from Norplant, where the capsules containing levonorgestrel are of unbiodegradable material, and Capronor is formed by a biodegradable polimerus. Finally, among the contraceptive methods that have been developed to date there are the vaginal rings; these rings are silastic made and allow a continuous release of levonorgestrel or progestins.

Algestone↗

Contraception guidance in women with pre-existing disturbances in carbohydrate metabolism.

OBJECTIVES: To review our studies on the clinical and metabolic impact of contraceptive methods in women with insulin dependent diabetes mellitus (IDDM) and women with previous gestational diabetes mellitus (GDM) in order to provide suggestions for the contraceptive counselling of these women. METHODS: The clinical events following first insertions of copper IUDs were studied in 103 women with IDDM and in 119 non-diabetic women. Moreover we studied the effects on glycometabolic control and lipid metabolism in women with well-controlled IDDM using low-dose oral contraceptives (OCs) containing ethinylestradiol combined with norethisterone (n = 10), levonorgestrel (n = 9) or gestodene (n = 11). Hemostatic and endothelial function was also studied in the women using the gestodene-containing preparation. Finally, we studied the impact of oral contraceptives on the insulin sensitivity in women with previous GDM. RESULTS: The continuation rates and indications for medical removal of the IUDs were similar in the diabetic and the non-diabetic women. There was no increased pregnancy rate or increased frequency of pelvic inflammatory disease in the diabetic women. The glycemic control was not changed by the OCs and none of the treatment regimens were associated with changes in plasma lipids linked to increased risk of atherosclerosis. Indications of increased fibrin formation, which seemed to be compensated by increased fibrinolytic activity, were noted with the gestodene-containing preparation. None of the women developed microalbuminuria during the study. Compared to normal women, we found reduced insulin sensitivity in the women with previous GDM using the pill. CONCLUSION: Intrauterine devices and barrier methods can be used by diabetic women with the same reservations as in the general population. Low-dose OCs do not influence the glycemic control and have no adverse impact on plasma lipids. The balance between fibrin formation and resolution was maintained during intake of the gestodene-containing pill. Our findings suggest that combined oral contraceptives can be used in women with uncomplicated IDDM and in women with previous GDM if clinical and metabolic monitoring can be ensured.

Case-Control Studies↗

The estrogen component of OCs: cardiovascular benefits and risks.

The relationship of oral contraceptive (OC) use to risk of venous thrombolism, stroke, and myocardial infarction continues to be evaluated. The estrogen component of combination OCs, which is primarily responsible for maintaining the endometrium and minimizing breakthrough bleeding (BTB) and spotting, was the initial focus of clinical and epidemiologic interest following early reports of an increased risk of vascular events with high-estrogen-dose formulations. OC estrogen continues to hold attention; current areas or interest include the relationship of estrogen to laboratory changes in hemostatic, lipid/lipoprotein, and carbohydrate variables, and, more important, to their possible clinical consequences. The historical view that OC-induced lipoprotein changes are responsible for observed increases in vascular risk in OC users is being debated, but the preponderance of evidence suggests that CO-related vascular disease is most likely due to thrombosis rather than atherosclerosis. This issue is made somewhat moot, however, by cumulative epidemiologic data indicating that although some combination OCs containing < or = 35 micrograms estrogen appear to produce a slight increase in the risk of venous thromboembolism, they have no adverse effect on the risk of myocardial infarction and minimal, if any, effect on the risk of stroke. The risks that may be associated with cigarette smoking and concomitant OC use have recently emerged as a somewhat contested issue relative to estrogen dose. Critical examination of the available information suggests that women over 35 years of age who smoke should be advised to use non-estrogen contraceptive methods and that smokers under age 35 may use any OC containing < 50 micrograms estrogen.

Adult↗

Oral and intrauterine contraception: a 1978 risk assessment.

This report reviews the current literature on the various risks associated with the use of oral contraceptives and intrauterine contraceptive devices. Reports on oral contraceptives from large prospective studies are not beginning to supplement the detailed reports resulting from earlier case-control studies. These studies suggest that in Western societies there is an increase in the incidence of a variety of circulatory diseases, with an increased risk of death. With intrauterine contraceptive devices it now has been fairly well documented that there is an increased risk of pelvic inflammatory disease. After reviewing and assessing the risks of both methods in some detail and comparing these risks to the benefits, the resultant conclusion is that the benefits continue to outweigh the risks for both methods, except for older women who choose oral contraceptives and also are heavy smokers.

Abnormalities, Drug-Induced↗