Rebecca Ramos

The effects of steroidal contraceptives on the well-being and sexuality of women: a double-blind, placebo-controlled, two-centre study of combined and progestogen-only methods

A placebo-controlled, double-blind study was carried out to assess the direct hormonal effects of combined and progestogen-only oral contraceptives on well-being and sexuality of women in two contrasting cultures. One-hundred-fifty women, who had been sterilised or whose partners had been vasectomised, were recruited from two centres-Manila, Philippines, and Edinburgh, Scotland. After one month pretreatment assessment, women were randomly assigned to one of three treatments (combined oral contraceptive (COC), progestogen-only pill (POP), or placebo; 50 within each treatment group, 25 per centre) and continued on treatment for four months. Assessment was by daily ratings, questionnaires and interviews. The COC adversely affected sexuality in the Edinburgh women, with 12 of the 25 women in this group also reporting the side effect of reduced sexual interest. There were modest negative effects of the combined pill on mood, more noticeable in the Edinburgh women. The POP was associated with no adverse effects on sexuality and some improvement in well-being in both centres. Possible explanations for the apparent lack of adverse effects in the Manila women are discussed. The negative effects reported may be less evident in women using the COC for contraceptive purposes but may lead to discontinuation in some women and warrant further investigation.

Assessing the acceptability, service delivery requirements, and use-effectiveness of the diaphragm in Colombia, Philippines, and Turkey.

The diaphragm is not available in many countries, despite the recommendations of numerous authors that it has important advantages as a woman-controlled method that offers some protection against sexually transmitted diseases, and one that is safe and free of side effects. An interagency team collaborated to introduce the diaphragm in Colombia, the Philippines, and Turkey, using the same protocol to assess the acceptability, service delivery requirements and use-effectiveness of the method. Eighteen public and private sector service delivery sites were involved and a total of 550 women were enrolled in the study. Provider training aimed to improve the quality of care with which all methods were delivered and included counseling about sexuality and reproductive health risks. The cumulative 12-month pregnancy rate of 10.1 (SE 1.7) per 100 woman-years is on the low end of previous studies of the diaphragm, and the 12-month continuation rate (57.2 [SE 2.4] per 100) compares favorably with that for oral contraceptives and the intrauterine device. Focus group discussions conducted with clients and providers indicated that the method was an important alternative for some women, particularly those who had experienced health problems with other methods or were unable to negotiate condom use with their partners. Provider biases diminished as they observed the strategic niche that the diaphragm filled for their clients. While providing the diaphragm requires training and good client-provider interaction, the requirements are consistent with those called for in the Programme of Action of the International Conference on Population and Development (ICPD, 1994). With proper attention to quality of care, the diaphragm can be successfully offered in resource-poor settings.

Effectiveness of lactational amenorrhoea in prevention of pregnancy in Manila, the Philippines: non-comparative prospective trial

Abstract Objective: To determine the contraceptive efficacy of the lactational amenorrhoea method. Design: Non-comparative prospective trial. Setting: Urban Manila, the Philippines. Subjects: 485 lower income, educated women with extensive experience of breast feeding. Intervention: Women were offered all available contraceptives for use after birth. Those who chose the lactational amenorrhoea method were taught the method, screened for the study, and followed for 12 months to determine the risk of pregnancy when the method was used. Main outcome measures: Life table pregnancy rates during correct and incorrect use of the method, censored monthly in the event of sexual abstinence or the use of another contraceptive method. Results: The lactational amenorrhoea method was 99% effective when used correctly (that is, during lactational amenorrhoea and full or nearly full breast feeding for up to six months). At 12 months the effectiveness during amenorrhoea dropped to 97%. Conclusions: The lactational amenorrhoea method provided as much protection from pregnancy as non-breast feeding women experience with non-medicated intrauterine devices and barrier methods. The contraceptive effect of lactation cannot be attributed to lactational or postpartum abstinence. Key messages Henceforth, data from clinical trials on contra-ceptives must be subject to the rigours of multiple censoring such as applied here. By excluding periods of abstinence from the calculation of risk of pregnancy, the contraceptive protection of the method cannot be attributed to postpartum or lac- tational abstinence During the first year post partum, the rate of pregnancy before the return of menses in lactating women was less than 3%

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.

A comparative analysis of three different dose combinations of oral contraceptives

Three different low-dose formulations of oral contraceptives were compared to determine the most suitable preparation for Filipino women as reflected in the first year continuation rates, incidence of side effects and failure rates. A total of 1,800 subjects were enrolled in the study from 18 health centers in six provinces in two regions of the Philippines, covering a total of 18,282 women-months of use. Sociodemographic characteristics were comparable. The monophasic levonorgestrel group showed the best performance followed by the triphasic preparation. The norethindrone group consistently showed higher drop-out rates, which may be due to the relatively higher incidence of side effects. For all three preparations, bleeding irregularities were low. There were no major side effects and no pregnancy was reported in one year of use. Noted was a distinct regional and provincial difference in recruitment and follow-up performance, possibly due to clinic, client or program factors.

Users' understanding of the lactational amenorrhea method and the occurrence of pregnancy.

It is unknown whether a users understanding of the Lactational Amenorrhea Method (LAM) is related to its successful use. A study of 876 LAM users in Pakistan and the Philippines collected information about womens understanding of LAM. The present analysis aims to determine: (1) the proportion of LAM users who understand the method, (2) whether any known factors can distinguish those who understand LAM from those who do not, and (3) whether an understanding of LAM is related to subsequent pregnancy. Over 75% of LAM users could consistently recite the LAM guidelines correctly for a full year postpartum. However, 38% of users failed to display, at least once, an understanding of LAM during the first year postpartum mainly by failing to abstain, to use another method or to explain their nonuse of another method when their LAM protection expired. LAM understanding generally could not be predicted by sociodemographic factors. The occurrence of pregnancy during the first year postpartum was not related to LAM understanding, regardless of how LAM understanding was defined, nor could it be predicted by any other measured characteristic of the users.

The Lem Device in an Immediate Postpartum Contraception Program

Experience with the LEM intrauterine device in an immediate postpartum program at the Jose Fabella Memorial Hospital, Manila, Philippines, is reported. During a 6-month period, the LEM was inserted in 1359 women immediately after normal term deliveries. The early expulsion rate was high, but removals for bleeding or pain were minimal. Pregnancy rates during the second 6 months of use were higher than those reported previously for postpartum insertions of the LEM device.

A 3-year evaluation of the TCu380Ag and the Cu-7

The TCu380Ag and the Cu‐7 intrauterine devices (IUDs) were evaluated in a randomized comparative clinical trial. A total of 198 women who had not recently been pregnant entered the trial in Manila, Philippines and were followed‐up through 3 years postinsertion. The 36‐month follow‐up rates were impressively high at 80.3 for TCu 380A users and 76.7 for users of the Cu‐7. Although the two IUDs demonstrated statistically similar termination rates, the findings suggest a higher efficacy for the TCu380Ag. Gross cumulative life‐table pregnancy rates were 0.0 and 4.5 for the TCu380Ag and Cu‐7, respectively, at 3 years. Overall 3‐year continuation rates were 74.3 and 64.9 for users of the respective devices.

A Program of IUD Insertions by Paraprofessionals and Physicians in the Philippines

A program of IUD insertions by paramedics and physicians was undertaken at the José Fabella Memorial Hospital. Both Lippes C and D were inserted in the postpartum and interval periods. Results show that paramedics can safely and effectively perform IUD insertions, although there are indications of a need to periodically monitor, and perhaps retrain, personnel, be they paramedic or physician, in the techniques of IUD insertion.

Experience with minilaparotomy in the Philippines.

This paper presents the socio‐demographic characteristics, medical histories, and clinical data on 651 women sterilized by interval minilaparotomy procedures in Manila, Philippines. About two thirds of the procedures were performed with local anesthesia; the Pomeroy technique was used for tubal ligation. In 2.8% of the patients, salpingectomy or fimbriectomy was performed on one side because of surgical difficulties and complications. Surgical difficulties were encountered in 19.8% of the procedures; adhesions (4.3%) and bowel interference (4.0%) were the most frequent causes of surgical difficulty. Complications occurred during surgery in 1.7% of the procedures. Early postoperative complications were noted in 9.1% of the cases. None of the patients required readmission to the hospital. While 612 women were followed up at 6 months, 299 were followed up at 12 months. One woman (0.2%) became pregnant after sterilization; at repeat minilaparotomy, ligation of the left round ligament rather than the tube was observed. Pelvic surgery, other than pregnancy‐related surgery, during the year following sterilization was reported for one patient who underwent exploratory laparotomy with appendectomy and oophorocystectomy. Menstrual pattern changes were minimal. The results of this study suggest that tubal ligation via minilaparotomy is practical, safe, and effective.