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PubMed1993

A comparative study of two low-dose combined oral contraceptives: results from a multicenter trial.

A comparative multicenter clinical trial of two low-dose combined oral contraceptives (OCs) was conducted in Malaysia, Egypt, Thailand, and Mexico. Efficacy, safety and acceptability were investigated in women taking either a norgestrel-based (NG) OC or a norethindrone acetate-based (NA) OC. This paper includes analysis of 892 women, all of whom were at least 42 days but within 26 weeks postpartum and randomly allocated to one of the above OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Baseline sociodemographic characteristics were similar for both groups, as well as compliance. There were nine unintended pregnancies reported; eight of these occurring in the NA group. Adverse experiences were minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. The group taking the NG-based OC had significantly (p < .05) fewer menstrual-related complaints. Discontinuations due to menstrual problems were significantly more common among NA users (primarily amenorrhea). Discontinuations in the NG group were primarily for other personal reasons, e.g. unable to return to the clinic. There was also a significant difference between the two groups for the 11-month gross cumulative life table discontinuation rates due to menstrual problems (p < .01); the NA group had the higher rate.

Adolescent↗
PubMed1993

Copper release from copper intrauterine devices removed after up to 8 years of use.

We studied the copper-releasing ability, weight and microscopic appearance of 2 copper-bearing intrauterine devices (IUDs), Copper-T Cu 200 (CuT) and Nova-T Cu 200 Ag (NovaT), after they had been in utero for up to 8 years. In addition, we studied whether IUDs removed from pregnant women showed different copper release. We found that IUD weight was a linear, negative function of duration of use, and that less than 20% of total copper would be released over a period of 8 years. The average copper-releasing ability was significantly higher for CuT than for NovaT (82.6 +/- 6.4 vs. 42.7 +/- 2.6 micrograms/day). The copper release was constant and thus unrelated to duration of use. Copper-releasing ability was similar in IUDs removed from pregnant and non-pregnant women. Fragmentation or minor defects only occurred in 3% of the IUDs and no correlation was found between deposits or corrosion and copper release rates. We conclude that CuT and NovaT both have constant copper release for at least 5-6 years and that the useful life-span probably can be prolonged to 6-8 years or more.

Copper↗
PubMed1993

Another look at the Dalkon Shield: meta-analysis underscores its problems.

Numerous non-comparative clinical trials of the Dalkon Shield appear to provide ample evidence that the Dalkon Shield was an effective IUD; they seem to yield little evidence that it was a dangerous device, nor markedly different from its contemporaries. Equating the performance of the Dalkon Shield IUD to that of the Lippes Loop or of Copper IUDs is erroneous, however, with respect to rates of pregnancy, expulsion, pelvic infection, septic abortion, death with the device in situ, and tubal infertility. Randomized studies show the Dalkon Shield had approximately double the pregnancy rates of the Lippes Loop D or Copper IUDs (P < .05) and a significantly lower expulsion rate. These differences coupled together with the distinguishing multifilament tail of the Dalkon Shield underlay the higher rates of pregnancy complications, including septic abortions with the device in situ and deaths, associated with the Shield. A five-fold increased risk of hospitalized pelvic infection among Dalkon Shield users found in the Women's Health Study resulted not from ascertainment bias, but was related to the fact that Dalkon Shield users had more severe hospitalized PID than did other hospitalized women with PID and IUD use. Following cessation of distribution and of use of the Dalkon Shield, and following the FDA's recommendation to remove IUDs in case of pregnancy, there have been no deaths reported among pregnant American women with an IUD in situ in a 15-year period. Neither the IUDs of today nor those in use during 1970-1974 are equitable to the Dalkon Shield [corrected].

Case-Control Studies↗
PubMed1993

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↗
PubMed1993

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↗
PubMed1993

THe "U" technique: a new method for Norplant implants removal.

The standard technique for Norplant implants removal was compared with a new technique called the "U" technique, which employs the use of a modified no-scalpel vas deferens holding forceps to grasp and remove the capsules. Seventy-six women requesting Norplant implants removal were randomly assigned to Group 1 (standard removal technique) or Group 2 ("U" removal technique). Variables measured included: (a) time required for complete removal, (b) number of capsules not broken or damaged during removal, and (c) number of incisions required for removal of all six capsules. In clients with visible or palpable capsules, the standard removal technique required significantly more time to remove all six capsules, on average, than the "U" technique (19 versus 7 minutes, p < 0.001); also more capsules were damaged during removal (5.6 undamaged versus 6.0, p < 0.01). In addition, with the standard technique, five clients required two incisions for removal of all six capsules while none of the clients required more than one incision with the "U" technique. Our conclusion is that the "U" technique is a quicker and easier method of removing Norplant capsules than the standard technique.

Drug Implants↗
PubMed1994

The Emory method: a modified approach to Norplant implants removal.

Norplant implants were removed from fifty (50) patients using a modified approach to Norplant implant removal (Emory Method). Eighty-eight percent (88%) of the removals were accomplished in less than 10 minutes using this technique. The average time for removal of Norplant implants from 50 women included in the current study was 8 minutes. The Emory Method for Norplant implant removal includes three steps which are different from the technique developed by the Population Council. More anesthesia, a slightly longer incision and vigorous disruption of the tissue encapsulation surrounding the implants are recommended. The Emory Method is fast, safe and easy to perform. It has been successfully taught to over twenty-five clinicians.

Contraceptive Agents, Female↗
PubMed1995

Clinical performance of the TCu 380A and Lippes Loop IUDs in three developing countries.

The clinical performance of the Copper T 380A (TCu 380A) and the Lippes Loop intrauterine devices (IUDs) were evaluated for 12 months in a group of 710 women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at three collaborating research sites located in three developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the Lippes Loop IUD at 12 months (0.7 and 2.1 per women, respectively). Although this difference was not statistically significant (p = 0.25), it is similar to findings from other studies. The 12-month cumulative removal rate due to personal reasons was significantly different (1.4 and 0.0, respectively, 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, medical reasons, planned pregnancy or investigator's choice. A statistically significant difference (p = 0.03) was observed in the number of TCu 380A IUD users experiencing dysmenorrhea (26.1%) during the 12-month study period, compared to Lippes Loop IUD users (18.8%).

Adolescent↗
PubMed1995

Assessing the acceptability of Norplant contraceptive in four patient populations.

The object of this study was to review the experience of Norplant implants insertion at the University of Colorado Health Sciences Center with specific attention to the potential impact of source of care and/or clinic site of of insertion. Norplant implants were inserted at four different office sites, namely, adolescent-teen, resident, certified nurse midwife, and faculty physician. The charts of all patients who had Norplant implants inserted between April 1991 and September 1992 were reviewed and we attempted to contact each patient by telephone to assess clinical course and acceptability of Norplant contraceptive. We were able to contact 254 of 414 women (61%) who had Norplant implants inserted. The average length of time since Norplant implants insertion was 13.2 months. The only significant demographic difference between groups was that the adolescent-teen patients were younger, of lower parity, less educated, and were more likely to be single than the other three groups. The overall removal proportion was 14.6%, and removal proportions were not significantly different between any of the four groups. The primary reason for removal was unacceptable bleeding (32% of removers). Only 59% of patients returned for follow-up care. Faculty physician patients were significantly more compliant with follow-up compared to adolescent-teen and resident patients (p < 0.01). Patient retention of Norplant contraceptive is unrelated to age or the clinic setting in which the device was inserted. Since similar side effects are experienced by retainers and removers, it is unclear what other factors prompt women to seek removal. Particularly in the teen and resident groups, follow-up is poor.

Adolescent↗
PubMed1995

Characteristics and experiences of American women electing for early removal of contraceptive implants.

The study describes the experiences of 430 women who had Norplant(R) contraceptive implants removed prior to the five years of method effectiveness. Each subject was surveyed when the implants were inserted and again at the time of removal. Descriptive data are presented concerning perceptions of the method before insertion and after removal, reactions to the contraceptive and experiences associated with the removal procedure. Subjects' use of Norplant implants ranged from 14 days to 40 months, with a mean of 13.3 and median of 13 months. Over 95% reported changes in menstrual bleeding patterns and 95% experienced other non-bleeding related side effects. Non-bleeding side effects were the most frequently indicated reasons for removal, followed by bleeding changes. The mean removal time was 34 minutes with a median of 25 minutes. Over 48% reported experiencing significant pain during the removal procedure, and 27% stated that the pain was greater than expected. Despite electing for early removal of implants,the majority of women surveyed indicated satisfaction with all aspects of the method save its effect on their overall health. Although method-related side effects were intolerable for most subjects, their overall perception of the method was generally satisfactory.

Adolescent↗
PubMed1996

Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, Uniplant.

Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.

Adult↗
PubMed1996

Bleeding complaints during the first year of norplant implants use and their impact on removal rate.

The frequency of bleeding complaints during the first year of use and their influence on removal rate were analyzed in a retrospective cohort study of 491 Norplant implants acceptors. Removal rates were significantly higher in women having menstrual complaints (1.98% and 29.23% in the first and fourth trimester) than in those who did not mention them (0.79 and 5.07% in the same periods). In all periods of observation, most women who mentioned menstrual problems decided to continue using the method. Two possible explanations for this are that 1) the complaints did not persist for very long, and 2) the most frequent complaint mentioned was bleeding irregularity, which was not as strongly associated with removals as increased or decreased bleeding. The authors conclude that bleeding problems are the most important factor limiting the acceptability of Norplant implants, either being the main reason for removal (3.9 per 100 women) or influencing the rate of removal for other reasons. Adequate counseling appears to be critical for reducing the impact of bleeding problems on removal rates, and thereby increasing the acceptability of the method. The importance of research aimed at preventing or treating menstrual problems to improve the acceptability of the method is emphasized.

Adult↗
PubMed1996

Removal of deeply inserted, nonpalpable levonorgestrel (Norplant) implants.

Deeply inserted, nonpalpable contraceptive implants can often be removed easily using 6-8 cm3 of 1% lidocaine and a single 1 cm incision. There is no need for suturing of the incision. The location of nonpalpable implants not retrieved by this procedure can be determined by a plain, soft tissue x-ray (standard AP and lateral and internal oblique; 45-55 kVP) of the area where the implants are inserted. Removal can then be accomplished several weeks later.

Analgesia↗
PubMed1996

Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide.

The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.

Adult↗
PubMed1996

A comparative study of two techniques used in immediate postplacental insertion (IPPI) of the Copper T-380A IUD in Shanghai, People's Republic of China.

Chinese women in Shanghai who delivered vaginally and who chose to use an IUD for contraception received a Copper T-380A IUD inserted vaginally within 10 minutes after delivery of the placenta (i.e., immediate postplacental insertion, IPPI). Among them, 97.7% were primipara. The women were randomly divided into two groups: IUD inserted by hand and IUD via ring forceps. The follow-up rate of six months was 95.2%. Using Tietze's life table method and log rank test, the expulsion and other discontinuation rates were compared at three and six months postinsertion between these two different insertion techniques. Expulsions were the main reason for discontinuation. The six-month gross cumulative expulsion rates were 13.3 and 12.7 per 100 women in the hand-insertion group and ring forceps-insertion group, respectively. Discontinuation rates for medical removals (bleeding/pain) were 2.1 and 1.0 in these two groups, respectively. Neither of the differences was statistically significant (p > 0.05). No uterine perforation, infection or pregnancy occurred. The results suggest that these two different insertion techniques do not significantly affect discontinuation rates in vaginal IPPI using the TCu 380A, and the TCu 380A appears to be suitable for postpartum insertion in Chinese women. Other relevant issues, such as breastfeeding and IUD placement in uterine cavity, are also analyzed and discussed in this report.

Adult↗
PubMed1996

Modified needle elevation technique for misplaced Norplant implants removal.

This study reports on a simple, feasible and easily learned technique for Norplant implants removal. This technique is modified from the needle elevation technique. The objective of this study was to introduce an alternative Norplant implants removal technique, especially for misplaced capsules. Fifteen Norplant implants clients whose capsules were difficult to palpate had removal by this technique. The mean duration of Norplant implants use was 18.4 +/- 12.5 months. The mean length of removal time was 10.4 +/- 4.5 minutes. None of the capsules was damaged during the removal. No immediate or late complications were observed. The conclusion is that the modified needle elevation technique is a simple and easy method of removing misplaced Norplant capsules with less complications.

Adult↗
PubMed1981

Postpartum contraception.

Recently-delivered women who wish to avoid pregnancy should initiate contraception before ovulation. Since the return of ovulation is not predictable, regardless of the woman's lactation status and duration of postpartum amenorrhea, contraception should be initiated as soon as is reasonable after delivery. The choice of contraceptive method will depend on several factors, including: the woman's lactation status, the preference of the woman and her partner, and the health status of the newborns. For women who do not wish to have additional children, tubal sterilization through a minilaparotomy incision is the procedure of choice. For other women who are not lactating, all methods, with the exception of the use of cervical caps and diaphragms, may be initiated immediately after delivery. However, preference should be given to IUD use by lactating and non-lactating woman, especially for women who may not return for any additional postpartum care.

Contraception↗
PubMed1982

Experience with Lippes loop and copper-T intrauterine devices in rural Bangladesh.

Experience with IUD use among rural Bangladeshi women within two programmatic efforts demonstrates that the Copper-T IUD suited the needs of younger, lower-parity women better than Lippes Loop. The differential performance by the device was especially marked within the program that offered a broad selection of contraceptive methods and occurred mainly because of lower rates of expulsion and lower rates of discontinuation for bleeding and pain among the Copper-T users. Nevertheless, the easy availability of a wide choice of methods during the second program successfully encouraged dissatisfied IUD discontinuers to try other methods of contraception.

Adult↗