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PubMed1986

Contraception with the cervical cap: effectiveness, safety, continuity of use, and user satisfaction.

With the growing interest in barrier contraceptive methods, the cervical cap has come back into use in North America. We examined the cap's effectiveness, safety, continuity of use, and user satisfaction among 617 women who were fitted at a family planning clinic in Toronto, Canada, between May 1981 and November 1983. Follow-up information was available for 516 of these women. Using a life table analysis with Bayesian adjustment, the probability of becoming pregnant after 12 months of use was 0.166 with a standard error of 0.022. There is evidence that after 1 year of use the caps deteriorate and that this deterioration may increase the risk of pregnancy. Many of the women in this study were very satisfied with the cervical cap; however, such problems as dislodgement, discomfort to user and partner, difficulty with insertion and removal, and unpleasant odour affected acceptability and continuity of use. It is likely that these problems could be alleviated by improving the quality of or changing the materials, modifying the design to improve the fit, and providing a greater range of sizes.

Adolescent↗
PubMed1986

The effect of the contraceptive pill on blood pressure: a randomized controlled trial of three progestogen-oestrogen combinations in Szeged, Hungary.

As part of an international multicentered investigation a double-blind comparative clinical trial was conducted at the Department of Obstetrics and Gynecology, University Medical School, Szeged, Hungary, in order to study the effect of different combined oral contraceptives on blood pressure. Healthy, normotensive women were randomly allocated to either of the following oral contraceptives: 250 micrograms levonorgestrel + 50 micrograms ethinyloestradiol (LN 250 + EE 50), 250 micrograms levonorgestrel + 30 micrograms ethinyloestradiol (LN 250 + EE 30), 1 mg norethisterone acetate + 50 micrograms ethinyloestradiol (NA 1 + EE 50). Standardized blood pressure measurements were carried out at admission and 3, 6, 9, and 12 months after admission. Blood pressure change from admission to subsequent visits was analysed in subjects who were seen by the same observer both at admission and the follow-up under consideration. The systolic blood pressure slightly but not significantly increased in groups LN 250 + EE 50 and NA 1 + EE 50, whereas the diastolic pressure showed a minimal decrease. In group LN 250 + EE 30 both systolic and diastolic blood pressure increased significantly (+5.58 and +3.20 mm Hg, respectively) at the 12-month follow-up. The study supports previous findings that combined oral contraceptive use is associated with a moderate rise in blood pressure. The progestogen-to-oestrogen ratio in the pill may be as important in this context as the dose of either component itself.

Adolescent↗
PubMed1987

Ovulation detection following removal of levonorgestrel subdermal contraceptive implants.

The time to resumption of ovulation following the discontinuation of levonorgestrel subdermal implants (Norplant) was assessed in 10 women. A blood sample (2 ml) was taken at the time of Norplant removal and then twice weekly until the first evidence of ovulation (serum progesterone concentration greater than or equal to 5 ng/ml) was documented. Ovulation was resumed in 80% of the cases by 3 weeks and in all the cases by 7 weeks. Prompt return of ovulation following Norplant removal is an additional advantage of this mode of long-acting contraception.

Adult↗
PubMed1987

Clinical performance of a levonorgestrel-releasing intracervical contraceptive device during the first year of use.

One-hundred-and-ninety-eight women used a new type of levonorgestrel-releasing intracervical contraceptive device (LNG-ICD) designed to release 20 micrograms levonorgestrel/day. The insertion took place within 7 days of menstruation. Clinical performance during the first year of LNG-ICD use was evaluated. Seven pregnancies occurred during the study period; one in an epileptic woman using carbamazepine, 300 mg/day, and the other six in healthy women after unnoticed expulsion of the ICD. Sixteen spontaneous expulsions occurred. The most common reasons for removal were side effects, including bleeding disturbances, hormonal side effects and other medical reasons. The continuation rate was 72.6 per cent after one year. Three pelvic infections were observed.

Adult↗
PubMed1987

Quantitative studies on menstrual blood loss in IUD users.

Despite the introduction of new intrauterine devices (IUDs), the most important complication involving their use continues to be excessive menstrual bleeding. IUD use in developing countries with women who are already depleted in body iron stores may prove to be deleterious to their health. Mean amounts of menstrual blood loss (MBL) for women not using contraception in the western world is about 32 ml. This mean is increased to 52-72 ml with use of the Lippes loop and other non-medicated devices up to 24 months after insertion. For the Copper-7 and Copper-T-200 devices this mean increase is to 37-40 ml in the first month, decreasing to 30-38 ml at 12 months after IUD insertion. In the users of the Multiload-250 IUD at one month post-insertion the MBL is from 56 to 63 ml and from 36 to 39 ml at 24 months of use. The mean Multiload-375 device users at one month after insertion lose a mean of 45-73 ml at 24 months, 35-50 ml. With the progestogen-releasing IUD mean MBL is 27-36 ml at 1 month and 9-13 ml at 12 months post-insertion. Intermenstrual blood loss is significant only in the first month of use for all IUDs. Discontinuation rates for pain and bleeding with non-medicated IUDs are from 11.0-19.6 per 100 women per year, and for the copper IUDs 4.4 to 6.8 per 100 women in the first year of use. The main problem with prolonged menstrual bleeding is depletion of the body iron stores; this is highly significant with non-medicated devices, less important with copper devices and conversely, iron stores are increased in users of progestogen-releasing devices. This is based on serum ferritin measured up to 24 months after insertion. The ferritin values correlated well with the volumes of MBL. It is suggested, especially for women with low body iron stores, that there is an order of preference for IUDs to be used. This should be: firstly, the progestogen-releasing devices; secondly, the Copper-T and Copper-7 IUDs; thirdly the larger surface copper devices (Cu-T-220C, Multiload 250 and 375, Cu-T-380). Non-medicated devices are not to be recommended for these women.

Anemia, Hypochromic↗
PubMed1988

A comparative study of the ease of removal of intrauterine contraceptive devices.

This study compares the rates of easy and difficult removals of various types of IUDs. Eight-hundred-sixteen IUDs were removed in Auckland Family Planning Clinics in an 8-month period. Nearly 80% were the standard Multiload Copper 250. Eight-eight percent of all IUDs were easy to remove with another 7% requiring a hard pull. Of the remaining 5%, 3.5% required simple intracervical exploration, 1% required intrauterine exploration and 0.5% were referred to hospital. When compared with the standard Multiload, no IUD was statistically easier and only the Mini-Copper 7 was harder to remove at the 5% level of significance.

Family Planning Services↗
PubMed1988

The association between vaginal bleeding patterns and reasons for discontinuation of contraceptive use.

This paper describes the relationship between menstrual bleeding patterns recorded and reasons for discontinuing method use given by women using one of four types of hormonal contraception: combined oral pills, progestogen-only oral pills, a vaginal ring or depot-medroxyprogesterone acetate (DMPA). The women were recruited to five clinical trials, each of which lasted at least 48 weeks. The subject's reason for discontinuation was recorded if she stopped contraceptive use before the scheduled time. Overall, the reason expressed for discontinuing method use was a close reflection of the subject's experience. Among women using either type of oral contraceptive or a vaginal ring, subjects who discontinued for a non-menstrual reason or were lost to follow-up had bleeding patterns which did not differ markedly from those of women who continued method use. Only in the DMPA group was there any evidence that women who complained of non-menstrual side effects or were lost to follow-up might have ceased method use because they were unwilling or unable to tolerate their bleeding patterns. Subjects who discontinued because of amenorrhea had few bleeding/spotting days and at least one prolonged bleeding-free interval; women who complained of longer bleeding had long episodes and short intervals. Women who reported heavier bleeding had patterns which were similar to, but less extreme, than those of subjects who reported longer bleeding. The complaint of irregular bleeding, however, did not concur with the bleeding patterns recorded, regardless of contraceptive method. The predominant menstrual disturbance in this group of women was frequency of bleeding. They had no special difficulty in predicting either the time of onset or the length of their bleeding episodes. There were marked differences between individuals in terms of their acceptance of bleeding disturbances. Nevertheless, the results of this study confirm the importance of counselling. Women using DMPA tolerated far greater menstrual disruption than subjects using any other method. Subjects using an oral contraceptive were unlikely to have been warned of potential bleeding problems; when they encountered any, they tended to cease method use. In contrast, subjects using DMPA would have been advised to expect irregular patterns and possibly amenorrhea; prepared for such disturbances, their perseverance was remarkable.

Administration, Intravaginal↗
PubMed1988

Follow-up of men in the recovery period immediately after the cessation of gossypol treatment.

Variables in 46 men who had stopped taking gossypol in two centres in China were investigated for their predictive association with the degree and time of recovery of spermatogenesis. Thirty-nine (87%) were azoospermic at cessation of gossypol treatment. In those with sperm present the geometric mean concentration and total sperm count were 8.3 x 10(6)/ml and 30.7 x 10(6), respectively. Twenty-eight (61%) recovered to a defined threshold spermatogenic function (sperm concentration greater than or equal to 20 x 10(6)/ml), with median recovery time 1.1 years. However, 18 men (39%) had not recovered after a median follow-up of 1.9 years and, of these, 10 (22%) remained azoospermic. The failure of recovery was strongly associated with longer treatment, greater total dose of gossypol, smaller testicular volume, elevated FSH concentrations and, to a lesser extent, with greater body weight.

Contraceptive Agents, Male↗
PubMed1988

Clearance of levonorgestrel from the circulation following removal of NORPLANT subdermal implants.

The disappearance of levonorgestrel from plasma after the removal of NORPLANT subdermal implants was studied in 12 women who had been treated from 5.5 to 78 months. The existence of one or two half-lives for the rate of disappearance was assessed. The influence of body weight, body fat and length of treatment upon levonorgestrel clearance was studied through stepwise regression analysis. It was found that the levonorgestrel decay rate after implant removal can be entirely accounted assuming one half-life of 42 +/- 16 h (mean +/- SD; range 13 to 62 h). Stepwise regression analysis showed that levonorgestrel half-life is positively correlated with body weight and not significantly correlated with the length of treatment or body fat. It is concluded that, after long-term administration of levonorgestrel via subdermal implants, the major part of the steroid is cleared from plasma within 96 h and that only trace amounts are detected in the following days.

Adult↗
PubMed1989

Mini-pill in lactating women.

A non-comparative study of the progestogen-only oral contraceptive, norgestrel 0.075 mg, in breast-feeding women was conducted at the Centro de Investigaciones Regionales, Merida, Yucatan, Mexico. The study was designed to evaluate the overall acceptability and contraceptive efficacy of norgestrel in breast-feeding women. This report includes a survey of 200 women, all of whom were less than 26 weeks postpartum at admission; 113 were interval patients and 87 were postpartum. Follow-up visits were scheduled at 2, 6 and 12 months after admission. Overall, women experienced an increase in intermenstrual bleeding, amenorrhea, vaginal discharge and breast discomfort. The discontinuation rate at 12 months was 32.5 and the corresponding lost to follow-up rate was 22.5; this is a measure of acceptability. The 12-month life-table rate for pregnancy was 3.4 with a standard error of 2.0. Three women discontinued use of the mini-pill due to accidental pregnancy. One pregnancy was attributed to user failure and the woman conceived 9 months after entering into the study; the other two were attributed to method failure, one woman conceived 3 months after admission and the other conceived 6 months after admission.

Adult↗
PubMed1990

Clinical experience with the progestogen-only pill.

Experience with the progestogen-only pill (POP) in a family planning clinic is presented. From the clinic records, 408 women were identified who had opted to use a POP. Of these, 50 women had used the POP during lactation and these were excluded from the analysis. The remaining 358 women used the POP for up to 150 months, giving a total of 18,125 women-months of use. Three pregnancies occurred, giving a Pearl Index of 0.2 per 100 women-years. Non-menstrual side effects were minor and were reported by 77 women. For the women who discontinued the POP, the main reason was menstrual irregularity (47.5%). However, despite the long-term use by most of the women, almost 40% maintained a mostly regular menstrual pattern. Our findings suggest that the POP provides a very acceptable method of oral contraception for many women and that it should be more actively promoted.

Adult↗
PubMed1990

The clinical acceptability of a non-medicated vaginal ring.

In an open study the acceptability of a newly designed vaginal ring was evaluated. The ring, being developed for contraceptive purposes, was made of Silastic and did not contain any medication. Three groups of 10 healthy female volunteers were selected after informed consent. The 6 nulliparous and 24 parous women were equally distributed over the 3 groups. The volunteers were instructed to insert the ring as high in the vagina as possible. In each group a ring of a different stiffness was used for 3 cycles. The first cycle started with the insertion of the ring on day 5 of the menstrual cycle or on the day oral contraception was started. Each cycle consisted of 21 days of vaginal ring use, followed by a 7-day ring-free interval. Expulsions, reasons for removal and complaints were recorded. Vaginal cultures were obtained before insertion and after the third cycle. The vaginal ring was well accepted. There were no differences between the three groups of women using rings of different stiffness. Twenty-two women completed all 3 cycles. Four women (3 nulliparous) stopped after one day. One of the nulliparous women who stopped after one day complained of expulsions, the only one in the study. The 4 women who stopped after a longer period were all parous. In the first cycle several women complained of vaginal discharge, coital problems or foreign body feeling. The complaints decreased in the second cycle and almost disappeared in the third. The rings had no influence on the vaginal flora.

Adult↗
PubMed1990

Five years experience of intrauterine contraception with the Nova-T.

This study was conducted to evaluate the clinical performance of the Nova-T IUD. The insertion period was from November 1981 to November 1982. Two-hundred-and-one (201) consecutive IUDs were inserted in women attending a family planning clinic and they were followed for a period of 5 years. Most events occurred in the first 2 years of the study and there were no pregnancies in the 3rd, 4th or 5th year. The pregnancy rate after 5 years was 3.2 or a Pearl index of 1.21 which is very good compared to other methods of contraception now available. Our conclusion is that the Nova-T IUD is an excellent method of contraception and it can be left in place for a period of 5 years.

Adolescent↗
PubMed1990

Insertion site complications during the first year of NORPLANT use.

Although review articles have provided much information on the NORPLANT system, information on insertion site complications based on multi-country trials has been limited to infection rates. This paper examines 2,674 NORPLANT acceptors from seven countries who were enrolled and followed for one year. The one-year incidence rates of infection (0.8%), expulsion (0.4%) and local reaction (4.7%) varied widely among countries and clinics within a country. In contrast to previous reports that insertion site complications occur during the first few weeks of use, these data show that a substantial proportion of insertion site infections (34.6%) and implant expulsions (64.3%) were reported after the first two months of use, while 35.7% of local reactions were reported after 4.5 months of use. Of the 16 women with infections who did not have the implants immediately removed, 8 eventually required or requested removal, indicating that the ICCR recommendation for immediate removal in case of infection appears appropriate. An awareness of the frequency of insertion site complications, distribution of the time of onset post-insertion and potential sequelae of complications will aid clinicians in better client counseling and complication management.

Adult↗
PubMed1991

Oral contraceptives and neoplasia of the uterine corpus.

Effects of oral contraception on neoplasia of the uterine corpus are reviewed on the basis of epidemiologic studies reported to date. A duration-related protective effect against endometrial cancer occurs from use of combined oral contraceptives, those in which each active pill contains both estrogen and progestogen. The risk before age 60 years is reduced by about 38% with two years of use; use of combined OCs for 4, 8, and 12 years, respectively, confers an estimated 51%, 64%, and 70% reduction in endometrial cancer risk. The protective effect appears not to be diminished by discontinued use, even 15 or more years after stopping. Whether protection continues throughout the entire postmenopausal period, even in the presence of long-term hormone replacement therapy, remains to be seen. Use of combined OCs may protect against uterine leiomyomas ("fibroids"), but the evidence is not conclusive. The few findings about effects of oral contraception on the risk of adenomatous hyperplasia are of uncertain validity. Only one study, with few patients, has considered oral contraception in relation to uterine sarcomas.

Contraceptives, Oral↗
PubMed1991

A comparative study of a progestin-only oral contraceptive versus non-hormonal methods in lactating women in Buenos Aires, Argentina.

A non-randomized comparative clinical trial of the progestin-only oral contraceptive (POC), Ovrette (75 mcg norgestrel) (Wyeth), versus non-hormonal methods was conducted at two clinics in Buenos Aires, Argentina. The trial was designed to assess the breast-feeding patterns of women choosing progestin-only oral contraception and non-hormonal methods of contraception, and to study the relationship between lactation and the clinical performance of a POC. Five-hundred women were allocated to either the progestin-only pill group (n = 250) or to the non-hormonal group (n = 250) and were followed up monthly for six months after admission. Measurements in mean infant weight, mean infant length, and mean head circumference were similar throughout the follow-up period. Non-hormonal users reported significantly more self-perceived decreases in milk production at the 5th and 6th month follow-up intervals. Acceptance and continued use of the pill were excellent, with only one woman discontinuing because of a pregnancy which was attributed to user failure. The principal side effect reported by women in both groups was intermenstrual bleeding.

Adolescent↗
PubMed1991

Open prospective multicenter trial with a new monophasic contraceptive combination containing gestodene.

In a large and open prospective multicenter trial of 12,250 cycles from 2,378 women, contraceptive efficacy, clinical tolerance and acceptability of a new monophasic contraceptive combination containing 75 mcg gestodene (delta-5-levonorgestrel) and 30 mcg ethinyl oestradiol were studied. The objective was to assess efficacy, safety, side effects and cycle control of this oral contraceptive on healthy women using no other additional birth control methods. Two women became pregnant (0.016%) during the trial; both were patient failures. There was no effect on systolic or diastolic pressures. An average weight increase of 0.3 kg was noted. Cycle control was excellent with 95% of the cycles free of spotting and 98% free of breakthrough bleeding after six cycles. No serious complications occurred. There was an overall incidence of 14% reported side effects (after six cycles), indicating that the hormonal combination is well tolerated. It should be noted that 41.4% of the patients had some complaint before starting the treatment. For all complaints, a highly significant improvement was seen during the treatment.

Adolescent↗
PubMed1992

Removal of intrauterine devices with missing tails during early pregnancy.

During a 70-month period, CO2 hysteroscopy was carried out on 52 pregnant women wearing IUDs with retracted tails. Ultrasonography was done prior to hysteroscopy to determine the size of the gestational sac and the site of the device. Successful removal of the device occurred in 46 cases. The technique, the findings of the study, and the limitations of the procedure are described.

Abortion, Spontaneous↗