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PubMed1987

Treatment of increased menstrual blood loss in IUD users.

Although bleeding problems represent the commonest side effect of IUDs and an important medical reason for discontinuation of use, its pathogenesis still remains incompletely understood and a standard universally acceptable therapy is not yet available. Proper insertion, change in size, material or shape of the IUD, as well as custom fitting to avoid dimensional incompatibilities, did not significantly improve the IUD-associated bleeding problems. Addition of copper to inert devices seemed to slightly improve the bleeding by reducing the antifibrinolytic activity but probably more was achieved through reducing the device size. Hormone-releasing devices appear to reduce the amount of bleeding significantly but a post-insertion phase of irregular spotting is a common complaint. Locally released antifibrinolytic agents were tried in limited investigations but a short period of drug release restricted further evaluation. Systemic administration of antifibrinolytic agents and non-steroidal anti-inflammatory drugs hold promise for the control of IUD-induced menorrhagia. The duration of bleeding and intermenstrual spotting still remains an unresolved clinical problem that requires further evaluation. This area of clinical concern in IUD use needs more in depth understanding and testing of new agents, particularly in the area of local release of antihemorrhagic agents.

Female↗

PubMed1987

Five-year experience with Norplant.

At Klinik Raden Saleh, Department of Obstetrics and Gynaecology, University of Indonesia, from 1 May until 31 August, 1981, Norplant contraceptive implants were inserted into 437 Indonesian women. The continuation rates of Norplant at first, second, third, fourth and fifth year were, respectively, 96%, 92%, 88%, 82% and 78%. Bleeding problems were the most common cause for removal. The cumulative five-year net pregnancy rate for Norplant was 1.8 per 100 women. The Norplant contraceptive system is thus seen to combine the highest acceptability as measured by its continuation rate with the highest long-term effectiveness among the available temporary contraceptive methods.

Adult↗

PubMed1987

Norplant contraceptive implants: rods versus capsules.

Norplant contraceptive implants are silastic implants containing levonorgestrel. When placed subcutaneously in the medial aspect of the upper arm, they release low levels of levonorgestrel in a constant manner over an extended period of time. Comparative studies of two silastic rods versus six capsules containing levonorgestrel were studied in 250 subjects for 4,464 months of use. Only one pregnancy occurred during the study. Side effect patterns were similar in both groups; the major side effect being irregular uterine bleeding. The bleeding, however, was well tolerated by subjects in both groups and discontinuation rate was very low. The two-rod system offers the advantages of easier insertion technique and shorter insertion time as well as ease of removal as compared to the six-capsule system. Norplant contraceptive implants offer a highly effective means of contraception which is particularly suited for women who are concerned about failure and compliance with oral contraceptives. This type of contraception should become well accepted, not only in underdeveloped countries, but in developed countries as well.

Adolescent↗

PubMed1988

Norplant contraceptive subdermal implants: one year experience in Singapore.

Norplant contraceptive implants are silastic implants containing levonorgestrel. This study describes our experience with 100 acceptors of Norplant implants in Singapore. There were no infections at the site after the implants were inserted. No pregnancies occurred during the first year of use. Disruptions of menstrual rhythm was the main complaint. However, the incidence of menstrual irregularities appeared to diminish with time. Implant users have tolerated this early disruption of their menstrual rhythm well and the continuation rate at the end of the year was 96.6 percent. Thus, it appears that Norplant contraceptive implants offer a highly effective means of contraception which should become well accepted in the near future.

Adolescent↗

PubMed1988

The analysis of menstrual bleeding patterns: a review.

Patterns of vaginal bleeding are an important factor in the acceptability of contraceptive methods. The analysis of data obtained from daily menstrual diary records is a major methodological problem to which no satisfactory solution exists. This review describes approaches to the analysis of bleeding patterns among contracepting and non-contracepting women and reviews the difficulties involved. The reference period method, introduced to avoid the arbitrary rules and definitions required for an analysis based on the concept of a menstrual cycle, is discussed and its limitations presented. The review draws on reports of meetings convened by the World Health Organization and the University of Exeter Family Planning Unit to discuss issues in the analysis. Previously unpublished methods are summarized and areas of controversy and topics for further research are identified.

Contraception↗

PubMed1988

A micro-computer software for the analysis of menstrual diaries: the menstrual diary system.

A microcomputer software was developed to analyse menstrual diaries following the reference period method as described in the article "The analysis of vaginal bleeding patterns induced by fertility regulating methods" published in this journal (Contraception, 34:253-260, 1986). The programme allows the analysis of groups of diaries selected according to subjects' characteristics recorded at commencement of the diary. It also offers flexibility in selecting options of analysis within the reference period method. The output can be presented graphically as Box-whisker plots. A tutorial is included in the package.

Contraception↗

PubMed1988

Assessing changes in vaginal bleeding patterns in contracepting women.

In clinical trials comparing alternative contraceptive methods, women often discontinue for disturbances in menstrual bleeding patterns. Vaginal bleeding diaries have been used to monitor these patterns, and this paper suggests two new methods of analysis of these data. One analysis measures trends over time in the occurrence of specific patterns and, a second analysis, the relation between a woman's current experience and the probability of continuing method use. Contrasts between these approaches and the reference period method of analysis are made. A randomised clinical trial of the relative efficacy of 100 and 150 mg doses of depot-medroxyprogesterone acetate (DMPA) is used for illustration.

Amenorrhea↗

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

Acceptability of injectable contraceptives in Assiut, Egypt.

The present work was a randomized comparative study of two injectable progestogen-only contraceptives. The first group (200 subjects) received 150 mg of depotmedroxyprogesterone acetate (Depoprovera) every 84 +/- 7 days and the second (200 subjects) received 200 mg of norethisterone enanthate (Noristerat) every 56 +/- 7 days. Acceptors of injectable contraceptives in Assiut, Egypt, were mainly women looking for fertility termination. Menstrual disruption was the main side effect among both treatment groups. Amenorrhoea was the commonest menstrual complaint and was the main reason for discontinuation in both groups. Only one pregnancy occurred during NET-EN use; two more pregnancies occurred, one in each of the two groups but there were indications that conception preceded the first injection. Menstrual irregularities were generally more frequent with DMPA users. However, DMPA had better one-year continuation rates than NET-EN (68.8 +/- 3.5 and 57.1 +/- 3.6 per 100 women, respectively).

Adolescent↗

PubMed1988

Norplant-2 rods: one year experience in Singapore.

Norplant-2 contraceptive implants consist of two silastic rods in which levonorgestrel has been incorporated with the polymer. This study describes our experience with 100 acceptors of the Norplant-2 rods in Singapore. No pregnancies occurred during the first year of use. Menstrual irregularities was the main complaint associated with the use of Norplant-2. However, the incidence of menstrual irregularities appeared to diminish with time and the continuation rate at the end of one year was 95.0 per cent. Thus, it appears that the Norplant-2 rod systems offer a highly effective, convenient means of contraception which should be well accepted in future.

Adult↗

PubMed1988

A comparative clinical trial of Norinyl 1/35 versus Brevicon in Rio Clara, Brazil.

A comparative clinical trial of two combined oral contraceptives (OCs) with equivalent estrogen content, but different amounts of progestogens, was conducted at the Centro Medico Especializado em Planejamento Familiar in Rio Clara, Brazil. The study was designed to determine the differences in discontinuation rates between Norinyl 1/35 (Syntex) and Brevicon (Syntex) as well as the frequency of selected side effects which might contribute to method discontinuation. Both OCs contain 0.035 mg of ethinyl estradiol; Brevicon contains 0.5 mg and Norinyl 1/35 contains 1 mg norethindrone. Three-hundred women enrolled in the study were randomly assigned to either the Norinyl 1/35 or Brevicon OCs and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Intermenstrual bleeding was reported by significantly more women in the Brevicon group than in the Norinyl group (p less than 0.05), and significantly more Brevicon users reported an increase in intermenstrual bleeding. At the end of the study period, no differences were found between the two OC groups in terms of discontinuation rates, but a large number of women in each group discontinued for menstrual problems. The total discontinuation rates at 11 months for both groups were extremely high: 68.2 for the Norinyl 1/35 group and 75.2 for the Brevicon users. The largest group of discontinuations were comprised of those discontinuing for menstrual problems, other personal reasons, planned pregnancy and side effects.

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↗

PubMed1989

Changes in menstrual blood loss after four methods of female tubal sterilization.

One-hundred females requesting tubal sterilization were included in this study. They were enrolled into 4 groups, each n = 25. They were allocated to a particular method of sterilization on a randomized basis. The four modalities used were: laparoscopic Falope ring application, bipolar electrocoagulation, Hulka clip application and Pomeroy tubal ligation via minilaparotomy. The menstrual blood loss (MBL) was quantitatively estimated, using the alkaline hematin method, prior to sterilization and after 3, 6 and 12 months. No significant changes in MBL were observed after the four sterilization techniques. Moreover, they did not differ significantly in this context.

Adult↗

PubMed1989

Blood loss following induction of early abortion using mifepristone (RU 486) and a prostaglandin analogue (gemeprost).

The pattern and amount of blood loss following induction of therapeutic abortion using mifepristone (RU 486) and a prostaglandin E analogue (gemeprost) was studied in 222 women of less than 63 days amenorrhoea. A single oral dose of mifepristone (400, 500 or 600 mg) was followed 48 hours later by a half or 1 mg gemeprost vaginal pessary. Complete abortion occurred in 218 (98%) women without necessity for surgical evacuation of the uterus. Bleeding commonly occurred following administration of mifepristone and prior to prostaglandin administration. The median duration of bleeding following abortion was 13 days with a range of from 1 to 44 days. There was a wide individual variation in measured blood loss between women, from 14 to 512 ml, with a median loss of 74 ml. The amount of blood loss was independent of the dose of mifepristone or prostaglandin but was significantly correlated with gestation. These results confirm that the combination of mifepristone and gemeprost is a highly effective and safe method of inducing therapeutic abortion medically. As the amount of blood loss increases with increasing gestation, it is suggested that its use should be restricted to women with amenorrhoea less than or equal to 56 days.

Abortifacient Agents↗

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↗

PubMed1989

Bleeding patterns and acceptability among Norplant users in two Asian countries.

Changes in menstrual bleeding patterns are the most frequent reason for discontinuing NORPLANT during the first year of use. Although NORPLANT is used by more women in Asia than in any other region, the changes that occur among these women are not well documented. In pre-introductory clinical trials of NORPLANT in the Philippines and Sri Lanka, 175 women were enrolled with greater than 95% continuing the method after one year. Daily menstrual bleeding calendars were kept by 94% of subjects for nine months and by 66% for one year. In contrast to findings in previous studies which showed that approximately 60% of NORPLANT users had bleeding disruptions in the first year of use, almost all of these women experienced bleeding disruptions. In a one-year study of menstrual pattern changes, increased bleeding was found to occur with the same frequency as reduced bleeding. However, the changes experienced by the Asian women tended to be decreases, rather than increases, in menstrual bleeding.

Adult↗

PubMed1990

Cycle control on low-dose oral contraceptives: a comparative trial.

Cycle control was studied comparing the monophasic oral contraceptive Loestrin with three low-dose phasic preparations (Triphasil, Ortho 10/11 and Ortho 7/7/7) in 391 women of whom 300 completed 6 cycles. Loestrin subjects had a rate of occurrence (31% of cycles) for intermenstrual bleeding (IMB) comparable to the rates for subjects on the phasic preparations (36%, 37% and 37%, respectively). Triphasil subjects had lower rates than the Ortho 10/11 and Ortho 7/7/7 subjects (p less than 0.01) in cycle one when all subjects were analyzed and in pre-study users when continuing menstrual flow (CMF) episodes were not included as IMB. IMB was a cause for dropping out of the study in 7% of subjects who were evenly distributed between groups. There were no differences between groups for BTB when perceived by subjects as a side effect. Spotting was perceived as a side effect more often with Ortho 10/11 and Ortho 7/7/7 use than with Triphasil (p less than 0.01). Loestrin, Ortho 10/11 and Ortho 7/7/7 subjects were more likely to report amenorrhea (p less than 0.001) and less likely to report leg cramps (p less than 0.01) compared to those on Triphasil. Triphasil subjects were less likely to report acne than subjects on Ortho 7/7/7 (p less than 0.01).

Adolescent↗

PubMed1990

Modern oral contraceptives and dysmenorrhoea.

Women with primary dysmenorrhoea not sufficiently helped by triphasic oral contraceptives (OCs) were offered a modern, low-dose monophasic OC containing 30 micrograms of ethinylestradiol and 150 micrograms of desogestrel. The study shows that for these women, the monophasic pill was the better alternative. The fact that 19 of 23 women who continue treatment on the monophasic OC indicates that this type of pill may be chosen as the first alternative for women with primary dysmenorrhoea.

Adolescent↗