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PubMed1988

Vaginal bleeding patterns among women using one natural and eight hormonal methods of contraception.

Menstrual diary records were obtained from a total of 5257 women using nine different methods of contraception, one natural and eight hormonal. This paper presents a comparative analysis of their vaginal bleeding patterns. The analytic procedures follow the recommendations of a recent WHO workshop on bleeding pattern analysis, which involve dividing each subject's diary into successive 90-day reference periods, calculating ten indices for each period, and classifying women according to whether they have "clinically important" bleeding disturbances. In general, the findings of this analysis confirm those of previous studies. Women using the natural method, who were deliberately selected for the regularity of their menstrual cycles, averaged three bleeding/spotting episodes of length 5 days in each 90-day period, with very little variability within or between women. Subjects given a combined oral contraceptive had more regular patterns than any other treated group, with short (4-day) episodes and 23-24 day bleeding-free intervals. Progestogen-only pill users had more frequent, longer episodes and shorter, less predictable intervals than combined pill users. Contrary to widely-held beliefs, the progestogen-only pills produced fewer spotting days than the combined pills, and almost no spotting episodes at all. Nearly half of vaginal ring users experienced some menstrual disturbance in each period; their most common problems were irregular, infrequent or prolonged bleeding. Women using the long-acting injectable, depot medroxyprogesterone acetate, had totally unpredictable patterns, with infrequent but prolonged bleeding/spotting episodes. The incidence of amenorrhea rose from just under 10% in their first injection interval to over 40% in their fourth. The methods of analysis recommended by WHO in 1985 still require substantial refinement. Nevertheless, they are more sensitive than those used previously for WHO trials and produce an easily understood, clinically meaningful characterization of bleeding patterns.

Administration, Intravaginal↗
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

The antiprogestational agent RU 486 as an abortifacient in early human pregnancy: a comparison of three dose regimens.

Three different regimens of RU 486, a progesterone receptor blocking agent, were compared for their ability to terminate early human pregnancy. One-hundred-fifty-three healthy women with a gestational length less than 49 days from the last menstrual period were recruited to the study and randomly allocated to one of three treatment regimens: 1) RU 486 10 mg x 2 for seven days; 2) RU 486 25 mg x 2 for seven days; or 3) RU 486 50 mg x 2 for seven days. No significant difference in efficacy was seen between the three dose regimens. Treatment with 10 mg x 2 x VII resulted in 73 per cent complete abortions, 25 mg x 2 x VII in 66 per cent and 50 mg x 2 x VII in 64 per cent complete abortions. Response to treatment, measured as reported onset of bleeding and passage of products of conception, however, occurred significantly later on the 10 mg x 2 regimen than on the other two dose regimens. In each treatment group, women who subsequently aborted completely had significantly lower pretreatment levels of hCG than women with incomplete abortion or continuing pregnancy. The treatment was well tolerated by the women and except for one woman who experienced a profound bleeding necessitating a blood transfusion, no serious side effects were seen.

Abortion, Induced↗
PubMed1989

Effect of Norplant contraceptive use on hemoglobin, packed cell volume and menstrual bleeding patterns.

A study was conducted to evaluate the effect of NORPLANT use on hemoglobin levels (HB), packed cell volume (PCV) and menstrual bleeding patterns. NORPLANT insertions were performed on 50 healthy volunteers in Ilorin, Nigeria, between January-March 1986. Whole blood samples were collected at admission, 6-month and 12-month follow-up visits, and each acceptor was asked to keep a daily bleeding calendar. Mean age of the acceptors was 32.8 years with a mean parity of 5.3 live births. Almost 50% of the acceptors indicated that they did not want any more children. After 12 month's follow-up, there were a total of three discontinuations, two for excessive menstrual bleeding and one due to husband's objection. Mean HB and PCV values remained relatively unchanged from admission to 12 months. Nearly 50% of the women experienced at least one episode of 8 or more days of continuous bleeding during the first six months of use, and about 20% reported amenorrhea of 90 or more days. Despite the incidence of menstrual bleeding irregularities, acceptability of the NORPLANT method was high as indicated by a 1-year continuation rate of 93.7 per 100 users. Clinically more important was the finding that despite a high proportion of women reporting menstrual pattern changes, HB and PCV levels remained unchanged.

Adult↗
PubMed1990

Clinical results with subcutaneous implants containing 3-keto desogestrel.

Eight healthy women using one Silastic implant of 30 mm length filled with 3-keto desogestrel, the active metabolite of desogestrel, were studied for 36-664 days. The release rate of 3-keto desogestrel was quite constant and around 30 micrograms/day. No ovulations occurred. One woman was amenorrheic, while the others had different bleeding patterns, often with periods of spotting. No other side effects were recorded. The mean plasma levels of 3-keto desogestrel were 0.9 nmol/l after 1 month and 0.5 nmol/l after 12 months. 3-Keto desogestrel was less effective than testosterone, estradiol or levonorgestrel in displacing 3H-dihydrotestosterone from SHBG. It is concluded that contraception with 3-keto desogestrel delivered through an implant is a promising method for further investigation. With a single implant we found a duration of at least one year.

Binding, Competitive↗
PubMed1991

Menstrual blood loss and body iron stores in Brazilian women.

Menstrual blood loss (MBL) studies are relevant for developing world women as this could be an important cause of anemia. Whenever a contraceptive method is to be used by such women, consideration should be given to the method which least affects the volume of MBL. In 309 women considered as clinically healthy, MBL, serum ferritin, serum iron and hemoglobin levels were measured: a mean MBL of 23 ml was found. Age, weight, height and previous oral contraceptive use did not affect MBL. Higher parity women may have higher MBL levels but their hematologic indices are not altered. While body iron stores (as judged by serum ferritin levels) are depleted in women who bleed more than 60 ml per cycle, clinical anemia may not be present until their blood loss exceeds 80 ml per menstruation. Brazilian women who lose more than 60 ml of menstrual blood associated with multiple pregnancies without adequate iron supplementation may have a depletion of their body iron stores.

Administration, Oral↗
PubMed1981

Menstrual blood loss with contraceptive subdermal levonorgestrel implants.

Six Silastic capsules each containing 30 mg of levonorgestrel were inserted subcutaneously in the left forearms of 13 volunteer women for contraceptive purposes. Quantitative determinations of menstrual blood loss were performed during a control cycle and during a 1-month period at the 1st, 6th, and 12th months of treatment. Days on which bleeding and spotting occurred were recorded and hemoglobin concentrations were determined. No changes were found in the amount of menstrual blood loss between the control cycles and the treatment cycles. The mean number of bleeding days during each of the three recorded treatment periods was significantly greater than that in the control cycles. No changes in hemoglobin concentration were found. None of the patients became pregnant during the study.

Adult↗
PubMed1986

Termination of early pregnancy by the progesterone antagonist RU 486 (Mifepristone).

We studied the effects of the progesterone antagonist RU 486 in 100 women with early, unwanted pregnancy (within 10 days of the expected onset of the missed menstrual period). Thirty-four women received oral doses of 400 mg (in four days), 26 received 600 mg (in four days), and 40 received 800 mg (in two days). Uterine bleeding occurred in all patients within four days of the first dose and continued for 5 to 17 days. In 85 of the women, a dramatic decrease in the plasma chorionic gonadotropin level was observed on day 6, and an empty uterus was confirmed by ultrasonography on day 13. Hence, these women were considered to have had a complete abortion. Fifteen subjects had persistently elevated plasma chorionic gonadotropin levels on day 6 and were considered not to have responded to RU 486. They all had uterine evacuation, which was facilitated by a softening of the cervix. The percentage of women with complete abortion was similar in all dosage groups. Furthermore, plasma levels of immunoreactive RU 486 were similar in subjects with and without complete abortion. The only important side effect observed in the responders was prolonged uterine bleeding in 18 percent, but neither blood transfusion nor curettage was required. We conclude that RU 486 is an effective and safe method for termination of very early pregnancy but that it should be used only under close medical supervision.

Abortifacient Agents↗
PubMed1985

Outpatient termination of pregnancy: halothane or alfentanil-supplemented anaesthesia.

Inhalation anaesthesia with halothane was compared with i.v. alfentanil in 66 unpremedicated patients undergoing suction termination of pregnancy as outpatients. Blood loss was significantly greater in the halothane group with a mean loss of 213 ml, compared with a mean loss of 89.8 ml in the alfentanil group. There was a greater frequency of nausea and vomiting in the alfentanil group, but no reduction in abdominal pain or need for analgesia after operation. Positive relationships were found between blood loss and duration of anaesthesia and between blood loss and gestational age in the halothane group, but not in the alfentanil group. We conclude that alfentanil-supplemented anaesthesia is satisfactory for suction termination of pregnancy when rapid recovery is required or the duration of the procedure is likely to be long, but that halothane anaesthesia cannot be recommended, especially if the procedure is long.

Abortion, Induced↗
PubMed1978

Vacuum aspiration at therapeutic abortion: blood loss at operation in multigravid women.

Therapeutic abortion by vacuum aspiration in the first trimester was carried out on 129 healthy multigravid women. The loss of haemoglobin at operation was estimated and the volume of blood calculated. The figures were compared to those in a group of primigravid women earlier reported. Blood loss increases with gestational length. Blood loss at first trimester abortion is smaller in multigravid than in primigravid women. In multigravid women blood loss is not significantly influenced by the woman's age and the number of pregnancies.

Abortion, Therapeutic↗
PubMed1989

Termination of early pregnancy with RU 486 (mifepristone) in combination with a prostaglandin analogue (sulprostone).

The antiprogestin RU 486 (mifepristone) has been shown to induce abortion when administered in early pregnancy, but the rate of incomplete abortion is high, around 40%. As blockage of the progesterone receptor increases the myometrial sensitivity to prostaglandins, a combination of RU 486 and a prostaglandin E2-analogue was tested for termination of pregnancy. One hundred and sixteen women, with a gestational length of less than 49 days from the first day of the last menstrual period, were treated with a daily dose of 50 or 100 mg RU 486 for 3 to 6 days, complemented with an intramuscular dose of 0.25 mg sulprostone (16-phenoxy-PGE2-sulfonylamide) on the last day of RU 486 treatment. The results confirmed that a reduction of treatment duration to 3 days is just as effective for inducing abortion (91% complete abortion) as a 4-6-day treatment regimen (95% complete abortion). Six patients had an incomplete abortion and in one the pregnancy continued unaffected. Side effects included intense uterine pain after the prostaglandin administration (16%), vomiting associated with the antiprogestin intake (9%) and after the prostaglandin administration (9%). One woman needed emergency curettage due to heavy bleeding. Six percent of the treated patients had a decrease in hemoglobin exceeding 20 g/l during the first week but no patient needed blood transfusion. No serious side effects were recorded.

Abortifacient Agents↗
PubMed1982

Control of IUD-induced bleeding by three non-steroidal anti-inflammatory drugs.

Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) reduced excessive IUD-induced bleeding. The effect of 3 different oral NSAIDs, namely indomethacin, Alclofenac, and flufenamic acid, on menstrual blood loss (MBL) and pain among women fitted with copper IUDs was studied and compared with a placebo on a randomized single blind basis. Each drug was given to 6 subjects (18 cases) over 2 consescutive cycles and was either preceded or followed by placebo for 2 more cycles. 1/2 of the cases on each drug started placebo medication in the 1st 2 months while the other 1/2 started by the drug. The oral treatment was begun on the 1st day of menstrual bleeding or spotting. Estimation of the daily MBL was done by the alkaline hematin method with mechanical extraction of sanitary pads. The 3 drugs tested in this study induced a significant reduction in MBL: maximum reduction by flufenamic acid medication, less with Alclofenac, and least with indomethacin medication. However, these reductions were not statistically different, and marked improvement in IUD-induced pain was observed under the effect of the 3 drugs.

Age Factors↗
PubMed1982

Menstrual pattern and blood loss with U-coil inert progesterone-releasing IUDs.

Menstrual blood loss (MBL) was estimated before and after insertion of the U-coil progesterone-releasing device in 37 patients. The same procedure was carried out in 39 cases fitted with an inert U-coil IUD of the same size and shape. Blood loss was estimated by the atomic abosorption technique during the preinsertion cycle and at the 1st, 3rd, 6th, 9th, and 12th postinsertion cycles. MBL was significantly reduced in patients fitted with a progesterone-releasing U-coil compared to those fitted with an inert U-coil who showed a significant increase in MBL. The cycle length was prolonged with the progesterone U-coil, and was reduced with inert U-coil devices. The duration of flow was significantly reduced with the progesterone U-coil and significantly prolonged with the inert device. The incidence of intermenstrual spotting was higher with the progesterone U-coil than with the inert U-coil. The hemoglobin level was significantly increased with the progesterone U-coil while it was significantly reduced with inert U-coil devices.

Contraception↗
PubMed1989

A comparative evaluation of the safety and contraceptive effectiveness of 65 mg and 100 mg of 90-day norethindrone (NET) injectable microspheres: a multicenter study.

The first of a second generation of slow-release injectable contraceptives is the norethindrone (NET) microspheres with a 90-day duration of action. It was evaluated at 65-mg and 100-mg doses for safety and contraceptive effectiveness in two randomized, single-blind trials among 131 women: 94 women for 12 months and 37 women for 6 months. The 6-month trial included additional evaluations of ovarian function and serum NET values. In the 6-month trial, no indication of ovulation was detected in the 100-mg dose group, while 3 of the 19 women in the 65-mg group showed signs of ovulation (progesterone greater than 3 ng/ml). No pregnancies were reported in the 100-mg group and one pregnancy in the 65-mg group resulted in a life-table pregnancy rate for that dose of 2.6 per 100 woman-years (95% confidence interval, 0 to 7.5). Days of vaginal bleeding were analyzed for 30 days before treatment and in 90-day reference periods after treatment. The mean number of vaginal bleeding and spotting days increased initially after the first injection in both dose groups, but decreased to below baseline in both dose groups after 6 months. The two doses appear comparable in clinical safety, side effects, vaginal bleeding patterns, and laboratory measures. With the preliminary estimate of efficacy, the 65-mg dose would be the minimally effective dose for the NET 90-day injectable contraceptive.

Adult↗
PubMed1986

Dysfunctional uterine bleeding.

Dysfunctional uterine bleeding is defined as abnormal uterine bleeding in the absence of organic disease. It is the result of anovulation or the abnormal local production of prostaglandins, and in each case the primary fault is inappropriate hormone formation. There are two approaches to diagnosis. The traditional one is primarily concerned with the exclusion of cancer of the endometrium; this concern results in the frequent resort to uterine curettage. The second approach is to limit curettage to patients whose symptoms are not ameliorated by medical therapy. The aim of medical treatment is either to produce secretory change in the endometrium or to decrease the formation of uterine prostaglandins. Intermittent progesterone treatment is used to cause secretory changes in the endometrium. Decreased production of the prostaglandins is achieved indirectly by causing atrophy of the endometrium or directly through the use of prostaglandin synthetase inhibitors. Surgery in the form of dilatation and curettage has no long-term therapeutic effect; hysterectomy is definitive therapy.

Adult↗