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A multicenter clinical trial of a progestin-only oral contraceptive in lactating women.

A non-comparative study of a progestin-only oral contraceptive (POC) containing 75 micrograms norgestrel was conducted at 22 sites in 14 countries. This study was designed to evaluate safety, contraceptive efficacy, and the overall acceptability of a POC in breastfeeding women. A total of 4,088 women entered the study over a three-year period and 29,399 woman-months of experience was gathered. Women had follow-up visits at 2, 6, and 11 months after admission. Headaches and vaginal discharge were the medical complaints most commonly reported by women, both prior to and after admission. Menstrual problems were reported by 59% of the women after admission. Of the 3,714 women who returned for at least one follow-up visit, 1,101 (29.6%) discontinued through month 11. The 11-month total discontinuation percentage, including those lost to follow-up (25.3%) was 51.6%. The most common reason given for discontinuation was a woman's desire for a change in contraceptive method. Only 4.9% discontinued pill use for menstrual problems, a percentage far below those generally reported for POCs. Twenty-nine unintended pregnancies occurred through 11 months giving a gross cumulative life table rate of 1.2 per 100 women (Pearl Index = 1.4). The POC appears to be a safe, effective and acceptable contraceptive option for postpartum breastfeeding women.

Adolescent↗

Four-year experience in a randomized study of the Gyne T 380 Slimline and the Standard Gyne T 380 intrauterine copper devices.

Performance of the Slimline and Standard models of the Gyne T 380 were measured through four years in a comparative study initially involving 996 women, seventy percent of whom were randomized to the Slimline device. Cumulative pregnancy rates of Slimline users were 0.3 +/- 0.2 per 100 both at three and at four years, as compared with rates of 1.5 +/- 0.9 and 3.8 +/- 1.7 at the same intervals for users of the Standard model (P > .05). The four-year explusion rate of the Slimline, 8.6 +/- 1.3 per 100, was significantly higher than the comparable rate of the Standard model, 4.4 +/- 1.6 (P < .05). The two Gyne T* models did not differ in continuation rates. First time IUD users, however, had substantially lower continuation rates than did former users (P < .001), in consequence of their relative youth and desire to have additional children. Other performance measures did not differ importantly by device.

Adolescent↗

Breakage and slippage of condoms in family planning clients.

Information was obtained from 540 clients on the 3,754 occasions when condoms were used over a one-month period. One or more major problems, breakage, slippage, leakage or a combination of these, occurred in 410 (10.9%) events, involving 217 (40.2%) clients. Breakage occurred in 209 (5.6%) events and slippage in 243 (6.5%). Leakage was almost always associated with breakage or slippage. There was a small group of accident prone clients. Breakage was more common in younger and inexperienced clients and in those who had previously experienced breakage. There were some differences in breakage rates between brands of condoms. Poor fitting condoms and non-spermicidal condoms were associated with more breaks. Other contributing factors included vigorous sex, dryness and tearing with fingernails. Additional lubrication did not protect from breaks and saliva was associated with more breaks than expected. Oil-based lubricants were associated with less breaks than expected. On many occasions (66.0%), clients were aware of the break before ejaculation occurred. Slippage was more common in the inexperienced and in those who had previously experienced slippage. There was no association between brand of condom and slippage but poor fitting condoms were associated with more slips. The most common reason for slippage was the condom being left on too long. Additional lubrication did not affect slippage.

Adolescent↗

Clinical performance of the TCu 380A and TCu 220C IUDs in four developing country family planning clinics.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 220C (TCu 220C) intrauterine devices (IUDs) were evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at four collaborating research sites located in two developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the TCu 220C IUD at 12 months (0.3 and 0.8, respectively), although this difference was not statistically significant (p > 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. No statistically significant differences were observed in the frequency of experiencing menstrual disturbances (i.e., dysmenorrhea, intermenstrual pelvic pain or intermenstrual bleeding) between the two IUD groups. These data suggest that the TCu 380A and TCu 220C IUDs are both appropriate options for contracepting women. The TCu 380A IUD, however, may be a more appropriate option for those women wishing to space births over a longer period of time.

Adolescent↗

Effectiveness of the non-spermicidal fit-free diaphragm.

Standard instructions for diaphragm use call for an individually sized latex diaphragm, used in conjunction with spermicide jelly. However, some investigators have reported that the diaphragm can be effective without a spermicide. A non-randomized trial designed to measure the contraceptive effectiveness of the diaphragm used without spermicide was conducted. A total of 110 self-selected women were enrolled to use a non-spermicide fit-free (60mm) diaphragm for a period of one year. They were advised to wear the diaphragm continuously, removing it once each day for washing but not within six hours after intercourse. Product-related problems related to insertion, retention and removal were few at both the 6- and 12-month follow-up visits, most commonly odor. The 12-month life table accidental pregnancy rate during typical use was 24.1 per 100 women (29.5 per 100 women without female barrier experience and 17.9 per 100 women with barrier experience). Over 85% of the women who returned for follow-up visits reported using the diaphragm during every act of intercourse. Until better data refute the traditional recommendations, users should be advised to add spermicide to fitted latex diaphragms.

Adult↗

A comparison between Nova T and Copper T 200 Ag in Hungary.

In a comparative use-effectiveness study, 855 Nova T and 883 TCu 200 Ag devices were inserted in a randomised sequence. By the end of the first year the gross rate of unplanned pregnancy was 1.1 per 100 users of Nova T and 2.1 per 100 users of TCu. After 2 years the pregnancy rates for Nova T and TCu were 3.1 and 4.8 per 100 users, respectively. Although there was no statistically significant difference between the rates for the two devices, they suggest a higher contraceptive efficacy for Nova T.

Clinical Trials as Topic↗

Secondary cervical perforation by the Copper-T intrauterine device.

Five cases of cervical perforation have been observed in women with a Copper-T IUCD, over a period of 5 yr. In all cases, the distal end of the stem (vertical limb) of the T had perforated through the cervical wall into one of the fornices of the vagina. Only 2 cases had symptoms leading to the discovery of the device, while the other 3 were discovered accidentally or on routine examination.

Adult↗

Seminal vesicles as organs of sperm storage.

This study was done to determine whether or not the seminal vesicles store spermatozoa. Half of the nonhuman primates' vesicles had sperm at autopsy as did one of the men dying a traumatic death. Seminal vesicle sperm storage may be the reason for continued spermatozoa in the ejaculates of men after vasectomy.

Adolescent↗

The effect of sexual behavior and a pregnancy on contraceptive method switching among black female teens.

Little is known about determinants of contraceptive method switching and few reports use data that can link events that occur close in time. Using retrospective information from the sexual calendars of black female teens who attended a reproductive health clinic, determinants of method switching in four areas were investigated. Method switchers, those who switched from an unprepared to a prepared method (n = 62) and those who switched from a prepared to an unprepared method (n = 18), were matched with nonswitchers who used the same initial method. Associations between switching and changes in the frequency of intercourse, sexual abstinence, and pregnancy were found. It is suggested that abstinence may have a different role in switching from each type of method. Counselors need to emphasize the importance of method continuation, even when sex has not occurred for a short period of time.

Adolescent↗

Contraception with progestogens and progesterone during lactation.

The growth and development of breastfed infants whose mothers used the contraceptive implants Norplant containing levonorgestrel and the injectable containing norethisterone enanthate were studied. Each group comprised of 120 women who initiated the use during the 5th to 7th week postpartum and were compared with a similar number of IUD using mothers. The breastfeeding performance did not differ between groups. The infants of the three groups performed similarly as regards their physical growth and health as well as the time of acquisition of the various milestones of psychomental development. A vaginal ring releasing 10 mg of the "natural" progesterone per 24 h was tested in breastfeeding mothers. The continuous use of the ring produced a serum level of progesterone around 4 ng/ml. This was effective in augmenting lactational infertility even through the later phases of breastfeeding when such an effect starts to wane off. The use of the ring proved to be acceptable and had no ill-effect on breastfeeding or infant growth or health. Using the natural progesterone as a contraceptive adds a new measure of safety, since the amount of the steroid secreted in the mother's milk will not be effectively absorbed from the infant's gut. These studies suggest the possibility of using two new methods for breastfeeding mothers; Norplant and the progesterone vaginal contraceptive ring. These can be initiated early postpartum, whenever this is considered needed.

Contraceptive Devices, Female↗

Unintended pregnancies with the etonogestrel implant (Implanon): a case series from postmarketing experience in Australia.

This paper describes a case series of over 200 unintended pregnancies associated with the etonogestrel implant, Implanon. These cases have been reported to the Australian Adverse Drug Reactions Advisory Committee during the first 3 years of marketing in this country. Of 218 cases included, 45 had insufficient data to assess the reason for contraceptive failure and 46 women were determined to have been already pregnant prior to Implanon insertion. Of the remaining 127 cases, the most common reason for unintended pregnancy was failure to insert the implant in 84 women. Other reasons included incorrect timing of insertion (19 cases), expulsion of Implanon (3 cases) and interaction with hepatic enzyme-inducing medicines (8 cases). The remaining 13 cases were classified as product/method failures once other reasons had been excluded. Using the 204,486 Implanon devices subsidized in this period to estimate the population exposed and the 218 pregnancies reported, the approximate failure rate in postmarketing use was 1 in 1000 insertions. These findings (and reports to medical indemnity insurers) have resulted in the development of guidelines and training for doctors inserting Implanon in Australia.

Australia↗

Tubal perforation by ESSURE microinsert.

Female tubal sterilization remains the most widely used method of permanent contraception worldwide. Recent studies have shown the new sterilization technique by ESSURE microinsert to be an effective method with decided advantages for the patient in terms of morbidity associated to a quick recovery. We discuss the possible hysteroscopic signs of tubal perforation and the right measures to take if a perforation is suspected, with respect to the possible complications and contraceptive failure.

Fallopian Tubes↗

Factors related to autonomy and discontinuation of use of natural family planning for women in Liberia and Zambia.

From 1983 to 1988, natural family planning programs were conducted in Liberia and Zambia. In Liberia 1055 and in Zambia 2709 women used natural family planning to avoid pregnancy. These users could become pregnant, discontinue use of the method, or become autonomous users. Women who changed intention did not stop use of natural family planning and were not treated as discontinuations. In a multivariate analysis, client's age, breastfeeding status, employment, urban/rural residence, time of registration in the program, and visit intensity were significantly associated with the outcomes. The most consistent association was that women who entered the programs in the later time periods were more likely to become autonomous users and less likely to discontinue use of the method or to experience an accidental pregnancy.

Adolescent↗

The modified mucus method in India.

The modified mucus method-Prajanan Jagriti (fertility awakening) is intended to serve the cultural needs of illiterate and semilliterate women. Over 10 months, 3003 women in northern India were taught the modified mucus method. There were a total of 42 pregnancies in 24,702 cycles for a Pearl index of 2.04. High effectiveness is attributed to the support that was provided to clients by the instructor.

Cervix Mucus↗

The Copper T 220C: a new long-acting copper intrauterine contraceptive device.

The Copper T(TCu) intrauterine contraceptive device (IUD) has been found to be an effective method of contraception but has the disadvantage of needing periodic replacement due to loss of copper through dissolution and fragmentation of the copper wire. Modification of the Copper T to overcome this disadvantage involved substitution of copper sleeves for wire on the vertical arm and the addition of copper sleeves to the horizonal arms to give an effective surface area of 220 sq. mm. of copper and an estimated life span of 20 years. A randomized comparative study was undertaken in 999 women to determine if the new model performed as well as the wire-wound Copper T 300. Net cumulative first-event rates at one year were as follows: TCu 220C-pregnancy 0.9, expulsion 3.7, removal for pain or bleeding 14.4; TCu 300-pregnancy 1.1, expulsion 3.1, removal for pain or bleeding 9.3. None of the differences in event rates were significant. If long-term follow-up confirms these findings, this new long-lasting copper intrauterine device could become the IUD of choice for all women.

Adolescent↗