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PubMed1981

A prospective multicentre trial of the ovulation method of natural family planning. I. The teaching phase.

The percentage of 869 women in five countries capable of being taught to recognize the periovulatory cervical mucus symptom of the fertile period was determined in a prospective multicentre trial of the ovulation method of natural family planning. The women were ovulating, of proven fertility, represented a spectrum of cultures and socioeconomic levels, and ranged from illiteracy to having postgraduate education. In the first of three standard teaching cycles, 93% recorded on interpretable ovulatory mucus pattern. Eighty-eight per cent of subjects successfully completed the teaching phase; 7% discontinued for reasons other than pregnancy, including 1.3% who failed to learn the method. Forty-five subjects (5%) became pregnant during the average 3.1-cycle teaching phase. The average number of days of abstinence required by the rules of the method was 17 in the third teaching cycle (58.2% of the average cycle length). To what extent the findings of this study can be extended to other couples remains to be demonstrated.

Adult↗
PubMed1975

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↗
PubMed1982

Sex of offspring of women using oral contraceptives, rhythm, and other methods of birth control around the time of conception.

Sex ratios were studied in a cohort of 33,205 newborns whose mothers had been questioned in early pregnancy about contraceptive use around the time of conception., The proportion of males was 0.517 (95% confidence limits [CL], 0.512 to 0.522). In the 9279 offspring of women who had used oral contraceptives (OC) in the 5 months prior to conception the sex ratio was 0.517 (0.507 to 0.527). There are sufficient numbers available for study for us to be 95% certain that OC causes no shift in sex ratio of 1% or more. Women who conceived within 2 months of stopping the pill had a small excess of males (0.528; 95% CL, 0.510 to 0.546), but this excess was probably due to chance. OC failures were followed by a raised sex ratio in the offspring (0.543; 95% CL, 0.509 to 0.577), and this excess of males was observed consistently in subgroups of maternal age, parity, race, and education. Failures of rhythm contraception were also associated with a consistent excess of male births (0.567; 95% CL, 0.514 to 0.620). No changes were observed after failures of IUDs, barrier, or chemical methods.

Adult↗
PubMed1978

Failure of withdrawal bleeding during combined oral contraceptive therapy: "amenorrhoea on the pill".

Serum follicle stimulating hormone, luteinising hormone and oestradiol-17beta concentrations have been measured in 21 patients with failure of withdrawal bleeding during combined oral contraceptive therapy and 21 matched controls with a normal bleeding pattern. Gonadotrophin and oestradiol-17beta concentrations were effectively suppressed in all patients during the phase of contraceptive ingestion. During the week between courses of treatment, there was a significant rise in the gonadotrophin (p less than 0.02) and oestradiol (p less than 0.05) concentrations in the patients but not in the controls. It is suggested that patients with failure of withdrawal bleeding during combined oral contraceptive therapy may have higher total oestrogen levels during the treatment-free week because of a less persistent suppression of hypothalamic-pituitary-ovarian function.

Amenorrhea↗
PubMed2002

Antibiotics and oral contraceptives.

With the exception of rifampin-like drugs, there is a lack of scientific evidence supporting the ability of commonly prescribed antibiotics, including all those routinely employed in outpatient dentistry, to either reduce blood levels and/or the effectiveness of oral contraceptives. To date, all clinical trials studying the effects of concomitant antibiotic therapy (with the exception of rifampin and rifabutin) have failed to demonstrate an interaction. Like all drugs, oral contraceptives are not 100% effective with the failure rate in the typical United States population reported to be as high as 3%. It is thus possible that the case reports of unintended pregnancies during antibiotic therapy may simply represent the normal failure rate of these drugs. Considering that both drug classes are prescribed frequently to women of childbearing potential, one would expect a much higher rate of oral contraceptive failure in this group of patients if a true drug:drug interaction existed. On the other hand, if the interaction does exist but is a relatively rare event, occurring in, say, 1 in 5000 women, clinical studies such as those described in this article would not detect the interaction. The pharmacokinetic studies of simultaneous antibiotic and oral contraceptive ingestion, and the retrospective studies of pregnancy rates among oral contraceptive users exposed to antibiotics, all suffer from one potential common weakness, i.e., their relatively small sample size. Sample sizes in the pharmacokinetic trials ranged from 7 to 24 participants, whereas the largest retrospective study of pregnancy rates still evaluated less than 800 total contraceptive users. Still, the incidence of such a rare interaction would not differ from the accepted normal failure rate of oral contraceptive therapy. The medico-legal ramifications of what looks like at best a rare interaction remains somewhat "murky." On one hand, we have medico-legal experts advising the profession to exercise caution and warn all oral contraceptive users of a potential reduction in efficacy during antibiotic therapy. These opinions are not evidence-based and rely heavily on one or two legal proceedings that cannot even be substantiated. On the other hand, there is one recently published legal proceeding in which the outcome was in favor of the oral surgeon. There is clearly a need for additional scientific research in oral contraceptive users that incorporates larger sample sizes, different time courses (prophylactic use versus standard 7-10 day use versus extended use), and different delivery systems (systemic administration versus local-controlled delivery) of antibiotic therapy. Though experts on this topic still recommend informing oral contraceptive users of the potential for a rare interaction, and for clinicians to advise them to employ additional barrier techniques of birth control during antibiotic therapy and for at least 1 week beyond the last dose [40], it is hoped that a set of guidelines regarding this controversy will eventually be published that is evidence-based, and not solely the results of anecdotal reports, expert opinions, and legal proceedings.

Anti-Bacterial Agents↗
PubMed1982

Two oral contraceptives, efficacy, serum proteins, and lipid metabolism. A comparative multicentre study on a triphasic and a fixed dose combination.

A triphasic, combined oral contraceptive containing 30 - 40 - 30 micrograms ethinyloestradiol (EE), and 50 - 75 - 125 micrograms levonorgestrel was compared with a fixed dose combination containing 30 micrograms EE and 150 micrograms desogestrel in a randomized multicentre trial in 193/199 women and 1 063/1 073 cycles, respectively. The duration of the trial was six months. Eleven centres in Denmark, Sweden, and Norway participated. Contraceptive reliability, bleeding control and side effects were evaluated. Influence on serum sex hormone binding globulin (SHBG) and transcortin was assayed as well as lipid metabolism. Three pregnancies occurred in the group using the triphasic regimen but none in the fixed dose regimen. Two of the three pregnancies were considered drug failures and the third a possible interaction. Possible reasons for the triphasic contraceptive failure are discussed with special reference to a British report on eight pregnancies. Bleeding control appeared to be equally good for the two preparations. However, the number of cycles with spotting, breakthrough bleeding and missed withdrawal bleeding were above the levels reported earlier on the triphasic regimen. About 80 per cent of the women completed the planned six months on either combination. Side effects were generally mild and in accordance with earlier reports on low dose oral contraceptives. Metabolically the triphasic levonorgestrel combination increased SHBG 100 per cent versus 200 per cent for the fixed desogestrel combination. Transcortin rose about 98 and 110 per cent, respectively. Both preparations induced similar changes in the levels of lipids and lipoproteins with the exception of a significant increase in the arachidonic content of cholesterol during treatment with the desogestrel-containing preparation.

Adolescent↗
PubMed1993

Single- and multiple-dose pharmacokinetics of a low-dose oral contraceptive in women with chronic renal failure undergoing peritoneal dialysis.

OBJECTIVE: Our purpose was to compare the pharmacokinetic parameters of oral administration of a 35 micrograms ethinyl estradiol, 1 mg norethindrone pill in peritoneal dialysis patients and normal women. STUDY DESIGN: A single-dose study was performed with five patients and four controls, followed by a multiple-dose study with five subjects in each group. Pharmacokinetic parameters were calculated by noncompartmental analysis and statistical analysis performed with Mann-Whitney U testing. RESULTS: There is no difference in the pharmacokinetic parameters for norethindrone in peritoneal dialysis patients compared with normal women. During multiple dosing an increased area under the concentration curve and decreased apparent oral clearance was observed for ethinyl estradiol in peritoneal dialysis patients compared with normal women. CONCLUSION: Peritoneal dialysis patients have decreased apparent oral clearance of ethinyl estradiol, leading to slightly higher serum concentrations compared with women with normal renal function. The clearance of norethindrone is the same in peritoneal dialysis patients and normal women.

Adult↗
PubMed1990

A guide to interpreting contraceptive efficacy studies.

Results of trials of various birth control methods and contraceptive products may provide misleading data and engender unrealistic expectations regarding efficacy. An analysis of published efficacy-trials reveals numerous fallacies in their design, performance, and reporting. Consequently, family planning clinicians find it virtually impossible to make valid comparisons among the methods or products. This article reviews the definitions and measures that have been used to assess contraceptive efficacy, describes and illustrates some of the flaws that confound interpretation and comparison of studies, and presents a set of recommendations for future studies. A summary table providing comparative failure rates for all methods of contraception is included.

Confounding Factors, Epidemiologic↗
PubMed1992

Reproductive failure as a health priority in the Third World: a review.

Family planning is synonymous with contraception in most third world countries, even though--in a great number of these countries--infertility, foetal death and child loss together constitute an important public health problem resulting in a high prevalence of childlessness. In underdeveloped countries much less attention has been paid to reproductive failures than in contraceptive failure and a highly biased approach towards "population control" has dominated. It is argued that childlessness represents a neglected aspect of family planning and that narrow-minded and goal-oriented population control is likely to be unsuccessful if it does not take into account all determinants of human reproductive failure.

Attitude to Health↗
PubMed1977

Contraceptive and sterilization practices and extrauterine pregnancy: a realistic perspective.

Comparative data on the incidence of ectopic pregnancy among accidental pregnancies associated with failure of a contraceptive or sterilization procedure are shown in Table 16. The practical clinical significance of the data in this review is predicated upon a number of related factors. One of the most important of these is the realistic failure rate (or success rate) of each contraceptive or sterilization method. The reported efficacy of various contraceptive methods has such a wide range that we have not attempted to calculate the likelihood that a woman may experience an ectopic pregnancy within a particular time period while using a specific method. The success or failure rate of each method is influenced by such variables as (1) the conscientiousness and ability of the patient to follow instructions, (2) the true failure rate of the method itself, (3) the experience of the clinician prescribing a method or performing a surgical procedure, and (4) other factors less clearly defined. Because of these many variables, the data shown in Table 16 were calculated on the basis of the number of reported accidental pregnancies which occurred coincidentally with, or subsequent to, a specific contraceptive or sterilization modality. (formula: see text). These data do not reflect the actual rate of occurrence of ectopic pregnancy with respect to woman-months of experience. We recognize the significant influence that age, race, gravidity, and socioeconomic factors have upon the incidence of ectopic pregnancy, but were unable to control for these factors in the data presented in this review. These data reprresent only what has occurred under specific circumstances and cannot logically be extrapolated to any specific future case or study series. It is important to emphasize the necessity of constant awareness by the medical and paraprofessional personnel of the potentially increased risk to the patient of an extrauterine pregnancy should one or another of these contraceptive or sterilization procedures fail. Complacency or a false sense of security on the part of responsible medical personnel concerning women who are "protected against conception" can quickly lead to a life-threatening situation in case of an ectopic pregnancy. Prompt diagnosis and definitive treatment of the extrauterine pregnancy is vital for the successful management of this serious complication of conception.

Contraceptive Agents, Female↗
PubMed1989

Contraceptive practice of Irish married and single first-time mothers.

This study surveys 100 married and 100 unmarried primiparous mothers, attending the National Maternity Hospital, Dublin, with regard to their contraceptive practice, their planning of their pregnancy and the timing of their first antenatal visit. Nineteen per cent of the married women, but 64% of the unmarried women, had never used any contraceptive method. The contraceptive pill was the most popular method for both groups, but while three in five of the married women had at some time used the pill, only a little more than one in five of the unmarried women had ever used it. One quarter of the women who had used contraception reported that their pregnancy was the result of a failure in their contraceptive method. Eighty-nine per cent of the single group and 20% of the married had not planned their pregnancy. None of the married women, but almost a quarter of the single, delayed their first antenatal visit until after they were 20 weeks pregnant.

Contraception Behavior↗
PubMed2000

Newer anticonvulsants: comparative review of drug interactions and adverse effects.

The tolerability and drug interaction profiles of 6 new anticonvulsants: oxcarbazepine, vigabatrin, lamotrigine, gabapentin, tiagabine and topiramate, are reviewed. In general, these new anticonvulsants are well tolerated and drug interaction problems are minor with the exception of the risk of failure of oral contraceptives during treatment with oxcarbazepine or topiramate. In this review, the clinical implications of the tolerability of these drugs are discussed for different patient groups. The choice of which new anticonvulsant for which patient depends upon individual factors, in particular, seizure type, tolerability and practical administration factors. Treating elderly patients may be complicated by an increased sensitivity to adverse effects as these patients very often receive polytherapy for accompanying diseases. Drugs with very simple pharmacokinetic properties may be preferred in this group. Women of childbearing age face specific problems related to the epilepsy and to treatment with anticonvulsants. These include impaired fertility, failure of oral contraceptives and the risk of birth defects. Some new anticonvulsants may be suggested in preference to classical drugs to avoid these problems, but the human experience with newer anticonvulsants is still limited and, therefore, so is knowledge of the risk of congenital malformations in the offspring of mothers taking anticonvulsants. Psychiatric and behavioural changes frequently complicate treatment of patients with mental retardation. Some of the new anticonvulsants, in particular those affecting the gamma-aminobutyric acid (GABA) system such as vigabatrin, seem to exacerbate this problem and should be used with caution in these patients.

Abnormalities, Drug-Induced↗