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Norplant® use among urban minority women in the United States1
ORIGINAL RESEARCH ARTICLE
Norplant威 Use Among Urban Minority Women in the United States Sandra Glantz,* J. Christopher Glantz,† Nancy Campbell-Heider,‡ and Eric Schaff§ The aim of this study was to develop a profile of urban American women who chose Norplant威, determine factors associated with retention and early termination of implants, and to determine reasons for early removal. A total of 197 adult black and Hispanic women who had Norplant inserted were followed prospectively for up to 5 years. Interval and cumulative termination rates were calculated. Data were stratified by race and analyzed to include lost-to-follow-up (LTFU) subjects. Multivariate survival analysis was used to determine variables independently associated with termination. Cumulative continuation rates were 68% after year 1 and 13% after year 4. Significant predictors of retention included black race and lower parity. Probability of early termination increased with higher parity and Hispanic race. For black subjects, recent use of hormonal contraception was a predictor of retention. Menstrual changes and weight concerns were common reasons for removal. The Norplant 1-year continuation rate is lower than previously reported, but is higher than reported for oral contraceptives and Depo-Provera威. Future studies should stratify by age, race, and parity, and use standardized terminology to report intervals of use. CONTRACEPTION 2000;61:83–90 © 2000 Elsevier Science Inc. All rights reserved. KEY WORDS:
Norplant, subdermal implants, hormonal con-
traception
Introduction
W
hen Norplant威 was first introduced in the United States, there were many questions about its acceptability to American women. Methods such as oral contraceptives (OC) and the condom were widely used, but daily pill-taking was difficult, and condoms were bothersome and less *Planned Parenthood of Rochester/Syracuse Region, Rochester, New York; †University of Rochester School of Medicine, Dept. of Obstetrics and Gynecology, Rochester, New York; ‡University at Buffalo, State University of New York School of Nursing, Buffalo, New York; and §University of Rochester School of Medicine, Department of Family Medicine, Rochester, New York Name and address for correspondence: Sandra L. Glantz, RNC, FNP, Planned Parenthood of Rochester/Syracuse Region, 114 University Ave, Rochester, NY 14605; e-mail: [email protected] Norplant姞 is the registered trademark of the Population Council Submitted for publication August 12, 1999 Revised December 28, 1999 Accepted for publication January 3, 2000
© 2000 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010
effective than hormonal methods. Both women and their partners were dissatisfied.1 Norplant seemed ideal, offering 5 years of highly effective, reversible contraception.2–5 Compliance requires only that the user not remove the implants. Like the intrauterine device and Depo-Provera威, Norplant does require some user adaptation to side effects.3,6 – 8 Although the method was studied extensively in less developed countries, with reportedly high continuation rates and patient satisfaction, studies of American women who selected Norplant have appeared in the literature only since 1991.9 –13 Study populations are limited largely to low-income, often minority women who qualify for Medicaid, and these reports often span ⬍2 years of Norplant use.8 –21 Teen and adult data are frequently combined, and often data are not stratified by race or parity. There are few data on white, middle-class women. Most of the American studies suffer from 25%–50% lost-to-follow-up (LTFU) data gaps, even for brief study periods.12,16,18 LTFU data are rarely included in analyses; such omission may artificially elevate the reported continuation rates. Durations of use reported in the literature are variable and are not readily compared. The purposes of this study were: 1) to develop a profile of urban American adult women who chose to use Norplant; 2) to determine factors associated with retention and early termination of implants; and 3) to determine the reasons for removal of implants. Specific terminology to define clearly the durations of method use are also presented and used.
Materials and Methods The study was prospective and descriptive in design. Subjects all were patients at an urban health center in Rochester, New York, who selected Norplant for contraception. They were continuously enrolled over a 4-year period, from 1 June 1991 to 30 June 1995. The health center serves a poor, minority population and delivers primary health care services to 15,000 persons yearly. Cost was not a barrier to Norplant use for any of the women in this study, because New York State Medicaid covers Norplant and grants were available to those with no other coverage. The women ISSN 0010-7824/00/$20.00 PII S0010-7824(00)00082-2
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could return for removal of implants at any time, and it was provided free if they could not afford it. The study was approved by the Human Subjects’ Review Board of the health center. Informed consent was obtained for the procedure and the study from all subjects. All subjects received a standardized evaluation that included counseling several days before implant insertion. They received written materials, available in English and Spanish, that explained the contraindications and potential side effects of the Norplant system and other contraceptive options. They were screened to determine their intent to delay pregnancy for ⱖ3 years. They were told that providers would attempt to manage medically any side effects, especially in the first year of use. They were advised to obtain pregnancy testing for missed menses in the first 2 months of use, or after regular menses followed by amenorrhea. They were encouraged to use available free condoms, but data on subsequent condom use were not collected. The protocol included review of the medical history and a physical examination. Implants were inserted within 5 days of the onset of menses. Abbott Plus (Abbott Laboratories, Abbott Park, IL) urine pregnancy tests were performed as indicated. Data were collected at time of insertion, with a structured interview by two of the clinician investigators. The demographic and social data collected are shown in Table 1. Subjects were given a follow-up appointment in 1 week, told to have a pelvic examination and Papanicolaou smear annually, and encouraged to return to the clinic as needed for any concerns or symptomatic complaints. Complaints of possible side effects were recorded. When reassurance was not sufficient, subjects with frequent or heavy bleeding were treated with Premarin威 (Ayerst Laboratories, Philadelphia, PA) 0.625 mg orally, twice daily; for 14 –21 days, or with one cycle of oral contraceptives. Headache was treated with ibuprofen, and hair loss concerns were managed with reassurance and a high protein diet. Subjects requesting removal were first interviewed using an openended format to determine their concerns and, where appropriate, were offered medical management. If they insisted on termination, an appointment was made for the removal procedure within 1 week. At the time of removal, a structured interview format was used to determine the reasons for implant termination. When more than two reasons were given, subjects were asked to indicate the two most important reasons. Alternative contraception was available. Depo-Provera威 became an available option in the second year of this study (1992). The charts of those subjects not known to have
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discontinued Norplant as of June 30, 1994 were reviewed through July 1996 to verify their implant status for the study. When chart review was not sufficient, subjects were contacted by telephone or mail to verify implant status. Demographic and health history data were tabulated for the study population (excluding LTFU subjects), and then divided by race (black versus nonblack). Variables with continuous distributions were compared by race using t tests for normally distributed data and the Mann-Whitney U-test for nonnormally distributed data. The 2 test was used for categorical data. All statistical analysis was done using StatView 5.0 (SAS Institute, Cary, NC) on a Macintosh G3 computer. Interval termination rates describe the proportion of subjects entering a time period who removed Norplant during that particular period of use (eg, 0 – 6 months). Cumulative continuation rates describe the percentage of all subjects in the study still using Norplant at the end of the time period. Demographic and health history characteristics of women who either terminated within the first year or who used Norplant for ⱖ1 year (excluding withdrawals and LTFU subjects) were compared to determine whether there were significant differences between these two groups. A Kaplan-Meier life table was constructed, with censoring for termination. Using a Cox proportional hazards model for multivariate survival analysis, variables were entered in a backwards stepwise process (p to remove ⫽ 0.1) to determine which variables were independently associated with termination. Variables considered first by univariate analysis for entry included race (black versus nonblack), gravity, parity, number or history of spontaneous abortions, number or history of induced abortions, insertion weight, age at first pregnancy, hormonal contraception within 1 month of implant insertion, duration of relationship with current partner, whether or not in school, last grade completed in school, whether graduated from high school, whether dropped out of high school, and presence or absence of a mental health diagnosis. Appropriateness of variables for entry into the Cox model was assessed by plotting natural log time versus natural log cumulative hazard to determine whether each variable’s hazard function was constant and proportional over time. Wald scores and likelihood ratios were calculated for all multivariate regressions. The Cox regression was repeated for subgroups divided by race. Next, sensitivity analysis was performed to analyze the effect of different retention/termination intervals of subjects for whom no data were available after the date of implant insertion. Health history and demographic characteristics of these LTFU subjects were
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Table 1. Characteristics of 178 adult women at time of Norplant insertion* Characteristic Age (yr) 20–29 ⬎30 Race Black Hispanic White Weight (lb) Gravidity Nulligravida G1–2 G3–4 ⬎G4 Parity Nullipara P1–2 ⬎P2 Ever had induced abortion Ever had miscarriage Mental health problem Age/first pregnancy 12–14 15–17 18–21 ⬎21 Last school grade completed 7–10 11–12 ⬎12 In school Dropped out of high school Current sexual relationship Relationship duration 0–12 mo 13–24 mo ⬎24 mo Previous contraception Barrier Hormonal Other None
N
(%)
168 10
(94.4) (5.6)
114 55 9
(64.0) (30.9) (5.1)
4 68 66 39
(2.3) (38.4) (37.9) (22.0)
7 112 58 84 34 39
(4.0) (63.3) (32.8) (47.5) (19.2) (21.9)
7 54 85 32
(3.9) (30.3) (47.8) (18.0)
29 122 19 51 51 134
(16.3) (68.5) (10.7) (28.7) (28.7) (75.3)
50 8 74
(28.1) (15.7) (41.6)
54 65 34 25
(30.3) (36.5) (19.1) (14.1)
Mean
Range
23.4 ⫾ 3.6
20–40
149.8 ⫾ 35.1 3.2 ⫾ 1.8
84–260 0–10
2.2 ⫾ 1.2
0–6
19.6 ⫾ 4.5
12–37
11.4 ⫾ 1.4
7–16
26.7 ⫾ 25.9
0–108
*Numbers and percentages may not always equal 178 and 100% because of missing data.
compared to those of the study subjects. LTFU subjects were consecutively assigned retention or termination intervals based on race quartiles (ie, termination or retention at quartile intervals based on study subjects of that race) and then added to the study population. To facilitate sensitivity analysis, durations of use for LTFU subjects were all arbitrarily decreased by 6 months, and the Cox regression analysis for the study-plus-LTFU population repeated. This analysis was repeated after increasing the duration of use for LTFU subjects by 6 months from baseline, and then a third time by setting LTFU durations of use to 1 week from insertion. These variations were intended to model the effects of different durations of use in LTFU subjects on the
results observed in the study population, to assess whether varying unascertainable retention/termination rates of LTFU subjects would alter study results.
Results All 197 women who received implants during the enrollment period were enrolled in the study. There were 19 subjects who had no visits since insertion and who were considered LTFU. A final chart review in December 1996 did not confirm the implant status for these subjects. The remaining 178 subjects were followed for up to 5 years. For 126 subjects, the date for removal of the implants was known. For seven subjects, implants were known still to be in use at the
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Table 2. Demographic and health history characteristics by race at time of Norplant insertion
Age (yr) Insertion weight ⬍150 lbs ⱖ150 lbs Gravidity Parity Induced abortion Ever had induced abortion Miscarriage Ever had miscarriage Relationship duration (months) Last grade completed Graduated/high school Dropped out/high school Age at first pregnancy (yr)
Black (n ⴝ 113)
Hispanic (n ⴝ 64)
p value
23.4 (20–40) 155.7 ⫾ 35.1 55 (48.7%) 58 (51.3%) 3.4 (0–10) 2.2 (0–6) 0.9 (0–5) 58 (50.9%) 0.3 (0–3) 29 (25.4%)
23.4 (20–34) 139.4 ⫾ 32.7 44 (68.8%) 20 (31.3%) 2.8 (0–9) 2.1 (0–5) 0.6 (0–4) 26 (41.3%) 0.1 (0–4) 5 (7.9%)
0.49MWU 0.003t-test 0.01CS
23.1 (0–108) 11.7 (9–14) 74 (67.3%) 27 (24.5%) 18.9 (12–36)
34.2 (0–84) 11.0 (7–16) 29 (48.3%) 24 (40.0%) 20.8 (14–37)
0.001MWU 0.02MWU 0.02CS 0.04CS 0.02MWU
0.04MWU 0.71MWU 0.13MWU 0.22CS 0.06MWU 0.005CS
Data are given as mean (range) or number (percent). t-test, unpaired t-test; MWU, Mann-Whitney U test; CS, 2 test.
study’s end. There were 45 subjects whose implant status was not known by the study’s end, but for whom there was a visit date subsequent to insertion when the implants were noted to be still in use. This data was used in the survival analysis for these subjects. Some data were not available in certain areas for a small subset of women (eg, mental health diagnosis). Demographic and health history data are tabulated in Table 1. Subjects were 64% black and 30.9% Hispanic. Only four women were nulligravid and seven nulliparous. One-third had two or more children, and about one-half reported a prior history of one or more induced abortions. Hormonal contraception was the most common method of birth control preceding Norplant insertion. It is not known how many subjects received Norplant within the 6-week postpartum period. Of all subjects, 94% were previous patients at the health center. When split by race (black versus nonblack, the majority of the latter being Hispanic), black women had higher mean body weight at time of insertion, gravidity, numbers of miscarriages, last school grade completed, and percentage completing high school (Table 2). Black women had a lower mean duration of relationship with current partners, high school dropout rates, and age at first pregnancy. The Kaplan-Meier survival curve is depicted in Figure 1, and interval termination rates and cumulative continuation rates are listed in Table 3. Of the subjects, 68% continued use beyond 12 months after implant insertion. The interval termination rate was 16.7% for the first 0 – 6 months, 18.0% for 6 –12 months, and rose to 42.3% during the second year of use. During the third and fourth years, the interval
termination rate was fairly constant, at 38.8%– 46.2%. Beyond 4 years after insertion, only 13% continued use. When compared by race, interval termination rates were not significantly different during the first and third years. Black women did have significantly lower termination rates during the second year (19 of 66 ⫽ 29% vs 25 of 38 ⫽ 66%, p ⫽ 0.0002), and all Hispanic women had terminated by the fourth year after insertion. The characteristics of subjects who discontinued early versus those who retained Norplant during the first year of use were compared. Retainers had significantly lower gravidity and lower parity than terminators. For retainers versus terminators, mean ⫾ SD gravidity was 3.0 ⫾ 1.9 and 3.6 ⫾ 1.7, and mean ⫾ SD
Figure 1. Survival analysis curve for Norplant use over 5 years.
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Table 3. Cumulative continuation rates and interval termination rates in total study population Time Period
Number in cohort
Terminators
% Terminating during interval
Cumulative continuation rate (%)
Six months One year Two years Three years Four years
174 139 104 49 13
29 25 44 19 6
16.7 18.0 42.3 38.8 46.2
83.3 68.3 39.4 24.1 13.0
parity was 2.0 ⫾ 1.0 and 2.7 ⫾ 1.4, respectively. No other characteristics were statistically significant in predicting very early discontinuation. For the entire study cohort, there were significant independent associations of race and parity with termination (Table 4). Black women were 50% less likely to terminate, overall, compared with Hispanic women. For all study subjects, every one-birth increase in parity was associated with a 37% greater likelihood of implant removal. Recent hormonal contraception use was associated with a 47% greater likelihood of Norplant retention in black women, but there was no such association in Hispanic women. Increasing parity was the only variable associated with termination in Hispanic women. This association was stronger and of greater magnitude in Hispanic women than in black women. A comparison done between LTFU and study subjects by the variables of Table 1 found no significant differences between these two groups. Sensitivity analysis to test for potential biases because of possible differential variation in LTFU duration of use did not alter results of the survival model. The significant associations of black race and parity persisted when the LTFU subjects’ duration of use were varied by ⫾6-month intervals or to as low as 1-week retention. For this range of variation, the Cox regression coeffi-
cient for black race ranged from ⫺0.628 to ⫺0.718 (p ⫽ 0.0002) compared to a baseline of ⫺0.687, and the coefficient for parity ranged from 0.302 to 0.324 (p ⫽ 0.0004) compared to a baseline of 0.312. Only seven of 178 subjects (3.9%) continued Norplant use to 5 years. Table 5 shows the reasons for removal. Most subjects gave more than one reason, regardless of how long they had used Norplant. Multiple general reasons, such as headache, fatigue, hair loss, nausea, weight changes, breast symptoms, and appetite changes, were frequently reported by terminators in the first 0 – 6-month interval, and only rarely after that. The most common reason categories were menstrual irregularities (44.4%), weight concerns (32.3%), and headache (33.9%). Cramps and untreated menorrhagia were the most common menstrual complaints. Just over one-fourth of subjects complained of weight gain. Hair loss was a reason for just over one-fifth of the women. Social reasons were reported by 20.2% of subjects and included desire for pregnancy (12%), fears about cancer or other ill effects, partner demands for termination, or moving out of state. Only 3.2% had obtained a bilateral tubal ligation before removal of Norplant. Arm complaints such as itching or pain at the implant site, radicular pain from the site of implantation to the wrist, and visibility of the implants occurred in 17.7% of sub-
Table 4. Cox proportional hazards regression analysis of termination rates Variable Total study group* Black race Parity In school Black women† Parity In school Hormonal contracept. Hispanic women‡ Parity
Coefficient
Relative hazard (95% confidence interval)
p value
⫺0.687 0.312 0.373
0.503 (0.339–0.746) 1.366 (1.153–1.618) 1.452 (0.970–2.174)
0.0006 0.0003 0.07
0.212 0.395 ⫺0.636
1.236 (1.024–1.492) 1.484 (0.895–2.463) 0.529 (0.309–0.908)
0.03 0.13 0.02
0.461
1.585 (1.169–2.150)
0.003
Relative hazard ⫽ exponent “e” to the coefficient power. *168 observations, 113 events, 10 missing, Wald ⫽ 0.0001, likelihood ratio ⫽ 0.0001. †110 observations, 69 events, 4 missing, Wald ⫽ 0.009, likelihood ratio ⫽ 0.009. ‡63 observations, 49 events, 1 missing, Wald ⫽ 0.003, likelihood ratio ⫽ 0.004.
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Table 5. Reasons for implant removal Reason Menstrual (44.4%) Amenorrhea Menorrhagia-not treated Menorrhagia-treated Metrorrhagia Cramps Weight (32.3%) Gain Loss Hair loss Breast complaints Headache Acne Arm (17.7%) Pain Rash Other Pregnant at time of insertion Depression Social (20.2%) Desires pregnancy Partner desires pregnancy Had bilateral tubal ligation Other
Number (% of 124 patients) 7 (5.6) 17 (13.7) 10 (8.1) 6 (4.8) 15 (12.1) 34 (27.4) 6 (4.8) 28 (22.6) 5 (4.0) 42 (33.9) 13 (10.5) 15 (12.1) 5 (4.0) 2 (1.6) 4 (3.2) 17 (13.7) 15 (12.1) 2 (1.6) 4 (3.2) 4 (3.2)
There were no statistically significant racial differences in reasons for removal, nor in stated reasons for removal when stratified by 1-year time intervals.
jects. There was one site infection after removal of the implants that was treated successfully with oral erythromycin. Psychologic reasons such as mood changes, depressive symptoms, and anxiety were uncommon reasons for termination.
Discussion The profile of the women who selected Norplant reported here is reflective of the population served by the health center and of most studies about Norplant use in the United States. Most women who chose Norplant were minority women with one or more children. Minority women without children or pregnancy experience rarely chose Norplant. We found that low parity was a significant independent predictor of Norplant continuation, which is consistent with previous reports.8,16,21 The association of increasing parity with early removal of Norplant was stronger for Hispanic women than for black women. Many Hispanic women are from large families and of the Catholic religion, which might influence contraceptive decision-making. Like other researchers, we found significant differences between black and Hispanic women.15,21 Black women were 50% less likely to remove Norplant than the Hispanic women. This finding complements the report by Polaneczky et al. that black women use
Depo-Provera longer than Hispanic women.22 Mean weight at insertion was higher for black women than for Hispanic women. Because obese women produce more exogenous estrogen than thinner women, it would be interesting to determine whether heavier women experience fewer bleeding problems and other side effects than lighter women. With more pregnancy experience, including abortion and miscarriage, slightly more education, and partner relationships of shorter duration, these black women may have had stronger motivation to avoid pregnancy than the Hispanic women. Because using OCs or DepoProvera in the month before Norplant use was a predictor for Norplant continuation for black subjects, it appears that black women already motivated to use a reliable contraceptive before choosing Norplant are good Norplant candidates. We attempted to clarify terminology for duration of use of Norplant. The Norplant package insert reports annual cumulative continuation rates of 80%–93% for year 1, 86%–90% for year 2, and 29.5% for year 5.23 Our reported cumulative continuation rates for every year of use are lower than those previously reported elsewhere except by Ebacher et al., who reported comparable continuation rates in Latina women and rates of 70%, 43%, 28%, and 22% for years 1– 4 of use in teenage women.2,3,5,12,16,18,24 We attribute our lower continuation rates to our low LTFU rate (more complete data), and to the minimal provider barriers to removal at our site.25 We report data for the cohort with 5 years of follow-up, longer than most other reports for American women using the 6-rod implants. Only seven of 178 subjects used Norplant for the full 5 years possible. The 1-year cumulative continuation rate of 68.5% surpasses the 50% reported rate for OCs and the 30% rate for Depo-Provera.1,22 The 10% LTFU rate reported here is the lowest of all studies reviewed. Our continuation rates closely approximate actual use of Norplant over 5 years by this sample of women. Events in LTFU subjects did not significantly differ from other subjects and our continuation rates were minimally changed when we statistically adjusted for either an early or late removal possibility. The reasons for removal of Norplant reported here were the same as reported elsewhere.5,16,26 Hair loss was diagnosed as telogenic effluvium, a diffuse type of alopecia related to an increase in the percentage of hairs that are in the resting phase of growth. It is frequently present in the postpartum state and is considered to be a reversible condition. Arm complaints were more common than expected, as arm pain was rarely mentioned in the early reports.5,27 Dizziness and depression were not significant reasons
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for removal in our study.5,28,29 Preinsertion counseling about common side effects and strategies to cope, including tampon use, appetite awareness, and overthe-counter medications, are an important aspect of providing this method. There are several limitations in this study, including the lack of a comparison group of women using other contraceptive methods and a potential bias in preinsertion counseling to select women seeking at least 3 years of contraception. The findings reported here should not be generalized to those who are not black or Hispanic inner-city women of low income status. Further research is needed to explore contraceptive decision-making about Norplant and other long-acting methods for Asian and white women, and for middle-class suburban women. Because 2–3 years is the interval of use chosen by most Norplant users in our study, the newer twocapsule formulation, with its 3-year effectiveness, would be a useful option. Infrequent clinic visits by Norplant users suggests these women may need reminders for Papanicolaou smears and other health screenings, as “they are not held hostage to their method” for receiving annual examinations.12 Continuation rates for Norplant may be lower than previous studies indicated, but are still impressive compared with the continuation rates of other hormonal methods. Minority women successfully using OC or injectables need to know about Norplant, because they are the most likely candidates for satisfied, long-term use. In future studies of newer contraceptives, a comparison of subjects by age, race, and parity is recommended, and LTFU subjects need inclusion in the analyses. More studies are needed about contraceptive decision-making by women and their partners, and about their motivations to be pregnant or not pregnant.
Acknowledgments We thank Karen L. Bossolt, medical student, summer 1994 for her assistance. The project was partially supported from a grant for pre-doctoral training in Family Medicine from the US Department of Health and Human Services. The Norplant Foundation provided free kits for those women without resources otherwise.
References 1. Potter L, Oakley D, de Leon-Wong E, Canamar R. Measuring compliance among oral contraceptive users. Fam Plann Perspec 1996;28:154 – 8. 2. Darney PD. Hormonal implants: contraception for a new century. Am J Obstet Gynecol 1994;170:1536 – 43.
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3. Kaunitz AM. Long-acting contraceptive options. Int J Fertil 1996;41:69 –76. 4. Post SG. Implantable hormonal contraceptive: emerging controversy. Obstet Gynecol 1994;84:1055–7. 5. Shoupe D, Mishell DR. Norplant: subdermal implant system for long-term contraception. Am J Obstet Gynecol 1989;160:1286 –95. 6. Shoupe D, Mishell DR, Bopp BL, Fielding M. The significance of bleeding patterns in Norplant users. Obstet Gynecol 1991;72:256 – 60. 7. Berenson AB, Weimann CM. Patient satisfaction and side effects with levonorgestrel implant (Norplant) use in adolescents 18 years of age or younger. Pediatrics 1993;92:257– 60. 8. Eilers G, Swanson T. Women’s satisfaction with Norplant as compared with oral contraceptives. J Fam Pract 1994;38:596 – 600. 9. Clarke LL, Schmit K, Bono C, Steele J, Miller M. Norplant selection and satisfaction among low-income women. Am J Public Health 1998;88:1175– 81. 10. Crosby UD, Schartz BE, Heartwell S. A preliminary report of Norplant implant insertions in a large urban family planning program. Contraception 1993;48: 359 – 66. 11. Cullins V, Blumenthal P, Remsburg R, Huggins G. Preliminary experience with Norplant in an inner-city population. Contraception 1993;47:193–203. 12. Cullins VE, Remsburg R, Blumenthal P, Huggins G. Comparison of adolescent and adult experiences with Norplant levonorgestrel contraceptive implants. Obstet Gynecol 1994;83:1026 –32. 13. Cushman LF, Davidson A, Kalmuss D, Heartwell S, Rulin M. Beliefs about Norplant implants among lowincome urban women. Contraception 1996;53:285–91. 14. Darney PD, Atkinson E, Turner S, MacPherson S, Hellerstein S, Alvarado A. Acceptance and perceptions of Norplant among users in San Francisco, USA. Stud Fam Plann 1990;21:152– 60. 15. Frank M, Poindexter A, Johnson M, Bateman L. Characteristics and attitudes of early contraceptive implant acceptors in Texas. Fam Plann Perspec 1992;24:208 –13. 16. Frank ML, Poindexter A III, Cornin L, Cox C, Bateman L. One year experience with subdermal contraceptive implants in the United States. Contraception 1993;48: 229 – 43. 17. Haugen MM, Evans C, Kim M. Patient satisfaction with a levonorgestrel-releasing contraceptive implant—reasons for and patterns of removal. J Reprod Med 1996;41:849 –54. 18. Kalmuss D, Davidson A, Cushman L, Heartwell S, Rulin M. Determinants of early implant discontinuation among low-income women. Fam Plann Perspec 1996;28:256 –9. 19. Rickets SA. Repeat fertility and contraceptive implant use among Medicaid recipients in Colorado. Fam Plann Perspec 1996;28:278 – 80. 20. Suman V, Van Winter J, Evans M, Simmons P, Jacobsen S, Manolis A. Levonorgestrel contraceptive implants in female patients 14 –21 years old. Mayo Clin Proc 1998; 73:10 – 6. 21. Weisman CS, Plichta S, Tirado D, Dana K. Comparison of contraceptive implant adopters and pill users in a family planning clinic in Baltimore. Fam Plann Perspec 1993;25:224 – 6.
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22. Polaneczky M, Guarnaccia M, Alon J, Wiley J. Early experiences with the contraceptive use of depomedroxyprogestereone acetate in an inner-city clinic population. Fam Plann Perspec 1996;28:174 – 8. 23. Wyeth Laboratories I. Norplant package insert. 1990. 24. Ebacher R, Prior S, Valdini A. Norplant utilization in a Latina inner-city population. J Health Care Poor & Underserved 1999;10:85–99. 25. Kalmuss D, Davidson A, Cushman L, Heartwell S, Rulin M. Potential barriers to the removal of Norplant among family planning clinic patients. Am J Public Health 1998;88:1846 –9. 26. Diaz S, Pavez M, Miranda P, Robertson D, Sivin I,
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Croxatto H. A five-year clinical trial of levonorgestrel Silastic implants (Norplant). Contraception 1982;25: 447–56. 27. Akhter H, Dunson TR, Amatya RN, et al. A five-year clinical evaluation of Norplant威 contraceptive subdermal implants in Bangladeshi acceptors. Contraception 1993;47:569 – 82. 28. Wagner KD, Berenson AB. Norplant-associated major depression and panic disorder. J Clin Psychiatry 1994; 55:478 – 80. 29. Wagner KD. Major depression and anxiety disorder associated with Norplant. J Clin Psychiatry 1996;57: 152–7.
Norplant威 Use Among Urban Minority Women in the United States Sandra Glantz,* J. Christopher Glantz,† Nancy Campbell-Heider,‡ and Eric Schaff§ The aim of this study was to develop a profile of urban American women who chose Norplant威, determine factors associated with retention and early termination of implants, and to determine reasons for early removal. A total of 197 adult black and Hispanic women who had Norplant inserted were followed prospectively for up to 5 years. Interval and cumulative termination rates were calculated. Data were stratified by race and analyzed to include lost-to-follow-up (LTFU) subjects. Multivariate survival analysis was used to determine variables independently associated with termination. Cumulative continuation rates were 68% after year 1 and 13% after year 4. Significant predictors of retention included black race and lower parity. Probability of early termination increased with higher parity and Hispanic race. For black subjects, recent use of hormonal contraception was a predictor of retention. Menstrual changes and weight concerns were common reasons for removal. The Norplant 1-year continuation rate is lower than previously reported, but is higher than reported for oral contraceptives and Depo-Provera威. Future studies should stratify by age, race, and parity, and use standardized terminology to report intervals of use. CONTRACEPTION 2000;61:83–90 © 2000 Elsevier Science Inc. All rights reserved. KEY WORDS:
Norplant, subdermal implants, hormonal con-
traception
Introduction
W
hen Norplant威 was first introduced in the United States, there were many questions about its acceptability to American women. Methods such as oral contraceptives (OC) and the condom were widely used, but daily pill-taking was difficult, and condoms were bothersome and less *Planned Parenthood of Rochester/Syracuse Region, Rochester, New York; †University of Rochester School of Medicine, Dept. of Obstetrics and Gynecology, Rochester, New York; ‡University at Buffalo, State University of New York School of Nursing, Buffalo, New York; and §University of Rochester School of Medicine, Department of Family Medicine, Rochester, New York Name and address for correspondence: Sandra L. Glantz, RNC, FNP, Planned Parenthood of Rochester/Syracuse Region, 114 University Ave, Rochester, NY 14605; e-mail: [email protected] Norplant姞 is the registered trademark of the Population Council Submitted for publication August 12, 1999 Revised December 28, 1999 Accepted for publication January 3, 2000
© 2000 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010
effective than hormonal methods. Both women and their partners were dissatisfied.1 Norplant seemed ideal, offering 5 years of highly effective, reversible contraception.2–5 Compliance requires only that the user not remove the implants. Like the intrauterine device and Depo-Provera威, Norplant does require some user adaptation to side effects.3,6 – 8 Although the method was studied extensively in less developed countries, with reportedly high continuation rates and patient satisfaction, studies of American women who selected Norplant have appeared in the literature only since 1991.9 –13 Study populations are limited largely to low-income, often minority women who qualify for Medicaid, and these reports often span ⬍2 years of Norplant use.8 –21 Teen and adult data are frequently combined, and often data are not stratified by race or parity. There are few data on white, middle-class women. Most of the American studies suffer from 25%–50% lost-to-follow-up (LTFU) data gaps, even for brief study periods.12,16,18 LTFU data are rarely included in analyses; such omission may artificially elevate the reported continuation rates. Durations of use reported in the literature are variable and are not readily compared. The purposes of this study were: 1) to develop a profile of urban American adult women who chose to use Norplant; 2) to determine factors associated with retention and early termination of implants; and 3) to determine the reasons for removal of implants. Specific terminology to define clearly the durations of method use are also presented and used.
Materials and Methods The study was prospective and descriptive in design. Subjects all were patients at an urban health center in Rochester, New York, who selected Norplant for contraception. They were continuously enrolled over a 4-year period, from 1 June 1991 to 30 June 1995. The health center serves a poor, minority population and delivers primary health care services to 15,000 persons yearly. Cost was not a barrier to Norplant use for any of the women in this study, because New York State Medicaid covers Norplant and grants were available to those with no other coverage. The women ISSN 0010-7824/00/$20.00 PII S0010-7824(00)00082-2
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could return for removal of implants at any time, and it was provided free if they could not afford it. The study was approved by the Human Subjects’ Review Board of the health center. Informed consent was obtained for the procedure and the study from all subjects. All subjects received a standardized evaluation that included counseling several days before implant insertion. They received written materials, available in English and Spanish, that explained the contraindications and potential side effects of the Norplant system and other contraceptive options. They were screened to determine their intent to delay pregnancy for ⱖ3 years. They were told that providers would attempt to manage medically any side effects, especially in the first year of use. They were advised to obtain pregnancy testing for missed menses in the first 2 months of use, or after regular menses followed by amenorrhea. They were encouraged to use available free condoms, but data on subsequent condom use were not collected. The protocol included review of the medical history and a physical examination. Implants were inserted within 5 days of the onset of menses. Abbott Plus (Abbott Laboratories, Abbott Park, IL) urine pregnancy tests were performed as indicated. Data were collected at time of insertion, with a structured interview by two of the clinician investigators. The demographic and social data collected are shown in Table 1. Subjects were given a follow-up appointment in 1 week, told to have a pelvic examination and Papanicolaou smear annually, and encouraged to return to the clinic as needed for any concerns or symptomatic complaints. Complaints of possible side effects were recorded. When reassurance was not sufficient, subjects with frequent or heavy bleeding were treated with Premarin威 (Ayerst Laboratories, Philadelphia, PA) 0.625 mg orally, twice daily; for 14 –21 days, or with one cycle of oral contraceptives. Headache was treated with ibuprofen, and hair loss concerns were managed with reassurance and a high protein diet. Subjects requesting removal were first interviewed using an openended format to determine their concerns and, where appropriate, were offered medical management. If they insisted on termination, an appointment was made for the removal procedure within 1 week. At the time of removal, a structured interview format was used to determine the reasons for implant termination. When more than two reasons were given, subjects were asked to indicate the two most important reasons. Alternative contraception was available. Depo-Provera威 became an available option in the second year of this study (1992). The charts of those subjects not known to have
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discontinued Norplant as of June 30, 1994 were reviewed through July 1996 to verify their implant status for the study. When chart review was not sufficient, subjects were contacted by telephone or mail to verify implant status. Demographic and health history data were tabulated for the study population (excluding LTFU subjects), and then divided by race (black versus nonblack). Variables with continuous distributions were compared by race using t tests for normally distributed data and the Mann-Whitney U-test for nonnormally distributed data. The 2 test was used for categorical data. All statistical analysis was done using StatView 5.0 (SAS Institute, Cary, NC) on a Macintosh G3 computer. Interval termination rates describe the proportion of subjects entering a time period who removed Norplant during that particular period of use (eg, 0 – 6 months). Cumulative continuation rates describe the percentage of all subjects in the study still using Norplant at the end of the time period. Demographic and health history characteristics of women who either terminated within the first year or who used Norplant for ⱖ1 year (excluding withdrawals and LTFU subjects) were compared to determine whether there were significant differences between these two groups. A Kaplan-Meier life table was constructed, with censoring for termination. Using a Cox proportional hazards model for multivariate survival analysis, variables were entered in a backwards stepwise process (p to remove ⫽ 0.1) to determine which variables were independently associated with termination. Variables considered first by univariate analysis for entry included race (black versus nonblack), gravity, parity, number or history of spontaneous abortions, number or history of induced abortions, insertion weight, age at first pregnancy, hormonal contraception within 1 month of implant insertion, duration of relationship with current partner, whether or not in school, last grade completed in school, whether graduated from high school, whether dropped out of high school, and presence or absence of a mental health diagnosis. Appropriateness of variables for entry into the Cox model was assessed by plotting natural log time versus natural log cumulative hazard to determine whether each variable’s hazard function was constant and proportional over time. Wald scores and likelihood ratios were calculated for all multivariate regressions. The Cox regression was repeated for subgroups divided by race. Next, sensitivity analysis was performed to analyze the effect of different retention/termination intervals of subjects for whom no data were available after the date of implant insertion. Health history and demographic characteristics of these LTFU subjects were
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Table 1. Characteristics of 178 adult women at time of Norplant insertion* Characteristic Age (yr) 20–29 ⬎30 Race Black Hispanic White Weight (lb) Gravidity Nulligravida G1–2 G3–4 ⬎G4 Parity Nullipara P1–2 ⬎P2 Ever had induced abortion Ever had miscarriage Mental health problem Age/first pregnancy 12–14 15–17 18–21 ⬎21 Last school grade completed 7–10 11–12 ⬎12 In school Dropped out of high school Current sexual relationship Relationship duration 0–12 mo 13–24 mo ⬎24 mo Previous contraception Barrier Hormonal Other None
N
(%)
168 10
(94.4) (5.6)
114 55 9
(64.0) (30.9) (5.1)
4 68 66 39
(2.3) (38.4) (37.9) (22.0)
7 112 58 84 34 39
(4.0) (63.3) (32.8) (47.5) (19.2) (21.9)
7 54 85 32
(3.9) (30.3) (47.8) (18.0)
29 122 19 51 51 134
(16.3) (68.5) (10.7) (28.7) (28.7) (75.3)
50 8 74
(28.1) (15.7) (41.6)
54 65 34 25
(30.3) (36.5) (19.1) (14.1)
Mean
Range
23.4 ⫾ 3.6
20–40
149.8 ⫾ 35.1 3.2 ⫾ 1.8
84–260 0–10
2.2 ⫾ 1.2
0–6
19.6 ⫾ 4.5
12–37
11.4 ⫾ 1.4
7–16
26.7 ⫾ 25.9
0–108
*Numbers and percentages may not always equal 178 and 100% because of missing data.
compared to those of the study subjects. LTFU subjects were consecutively assigned retention or termination intervals based on race quartiles (ie, termination or retention at quartile intervals based on study subjects of that race) and then added to the study population. To facilitate sensitivity analysis, durations of use for LTFU subjects were all arbitrarily decreased by 6 months, and the Cox regression analysis for the study-plus-LTFU population repeated. This analysis was repeated after increasing the duration of use for LTFU subjects by 6 months from baseline, and then a third time by setting LTFU durations of use to 1 week from insertion. These variations were intended to model the effects of different durations of use in LTFU subjects on the
results observed in the study population, to assess whether varying unascertainable retention/termination rates of LTFU subjects would alter study results.
Results All 197 women who received implants during the enrollment period were enrolled in the study. There were 19 subjects who had no visits since insertion and who were considered LTFU. A final chart review in December 1996 did not confirm the implant status for these subjects. The remaining 178 subjects were followed for up to 5 years. For 126 subjects, the date for removal of the implants was known. For seven subjects, implants were known still to be in use at the
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Table 2. Demographic and health history characteristics by race at time of Norplant insertion
Age (yr) Insertion weight ⬍150 lbs ⱖ150 lbs Gravidity Parity Induced abortion Ever had induced abortion Miscarriage Ever had miscarriage Relationship duration (months) Last grade completed Graduated/high school Dropped out/high school Age at first pregnancy (yr)
Black (n ⴝ 113)
Hispanic (n ⴝ 64)
p value
23.4 (20–40) 155.7 ⫾ 35.1 55 (48.7%) 58 (51.3%) 3.4 (0–10) 2.2 (0–6) 0.9 (0–5) 58 (50.9%) 0.3 (0–3) 29 (25.4%)
23.4 (20–34) 139.4 ⫾ 32.7 44 (68.8%) 20 (31.3%) 2.8 (0–9) 2.1 (0–5) 0.6 (0–4) 26 (41.3%) 0.1 (0–4) 5 (7.9%)
0.49MWU 0.003t-test 0.01CS
23.1 (0–108) 11.7 (9–14) 74 (67.3%) 27 (24.5%) 18.9 (12–36)
34.2 (0–84) 11.0 (7–16) 29 (48.3%) 24 (40.0%) 20.8 (14–37)
0.001MWU 0.02MWU 0.02CS 0.04CS 0.02MWU
0.04MWU 0.71MWU 0.13MWU 0.22CS 0.06MWU 0.005CS
Data are given as mean (range) or number (percent). t-test, unpaired t-test; MWU, Mann-Whitney U test; CS, 2 test.
study’s end. There were 45 subjects whose implant status was not known by the study’s end, but for whom there was a visit date subsequent to insertion when the implants were noted to be still in use. This data was used in the survival analysis for these subjects. Some data were not available in certain areas for a small subset of women (eg, mental health diagnosis). Demographic and health history data are tabulated in Table 1. Subjects were 64% black and 30.9% Hispanic. Only four women were nulligravid and seven nulliparous. One-third had two or more children, and about one-half reported a prior history of one or more induced abortions. Hormonal contraception was the most common method of birth control preceding Norplant insertion. It is not known how many subjects received Norplant within the 6-week postpartum period. Of all subjects, 94% were previous patients at the health center. When split by race (black versus nonblack, the majority of the latter being Hispanic), black women had higher mean body weight at time of insertion, gravidity, numbers of miscarriages, last school grade completed, and percentage completing high school (Table 2). Black women had a lower mean duration of relationship with current partners, high school dropout rates, and age at first pregnancy. The Kaplan-Meier survival curve is depicted in Figure 1, and interval termination rates and cumulative continuation rates are listed in Table 3. Of the subjects, 68% continued use beyond 12 months after implant insertion. The interval termination rate was 16.7% for the first 0 – 6 months, 18.0% for 6 –12 months, and rose to 42.3% during the second year of use. During the third and fourth years, the interval
termination rate was fairly constant, at 38.8%– 46.2%. Beyond 4 years after insertion, only 13% continued use. When compared by race, interval termination rates were not significantly different during the first and third years. Black women did have significantly lower termination rates during the second year (19 of 66 ⫽ 29% vs 25 of 38 ⫽ 66%, p ⫽ 0.0002), and all Hispanic women had terminated by the fourth year after insertion. The characteristics of subjects who discontinued early versus those who retained Norplant during the first year of use were compared. Retainers had significantly lower gravidity and lower parity than terminators. For retainers versus terminators, mean ⫾ SD gravidity was 3.0 ⫾ 1.9 and 3.6 ⫾ 1.7, and mean ⫾ SD
Figure 1. Survival analysis curve for Norplant use over 5 years.
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Table 3. Cumulative continuation rates and interval termination rates in total study population Time Period
Number in cohort
Terminators
% Terminating during interval
Cumulative continuation rate (%)
Six months One year Two years Three years Four years
174 139 104 49 13
29 25 44 19 6
16.7 18.0 42.3 38.8 46.2
83.3 68.3 39.4 24.1 13.0
parity was 2.0 ⫾ 1.0 and 2.7 ⫾ 1.4, respectively. No other characteristics were statistically significant in predicting very early discontinuation. For the entire study cohort, there were significant independent associations of race and parity with termination (Table 4). Black women were 50% less likely to terminate, overall, compared with Hispanic women. For all study subjects, every one-birth increase in parity was associated with a 37% greater likelihood of implant removal. Recent hormonal contraception use was associated with a 47% greater likelihood of Norplant retention in black women, but there was no such association in Hispanic women. Increasing parity was the only variable associated with termination in Hispanic women. This association was stronger and of greater magnitude in Hispanic women than in black women. A comparison done between LTFU and study subjects by the variables of Table 1 found no significant differences between these two groups. Sensitivity analysis to test for potential biases because of possible differential variation in LTFU duration of use did not alter results of the survival model. The significant associations of black race and parity persisted when the LTFU subjects’ duration of use were varied by ⫾6-month intervals or to as low as 1-week retention. For this range of variation, the Cox regression coeffi-
cient for black race ranged from ⫺0.628 to ⫺0.718 (p ⫽ 0.0002) compared to a baseline of ⫺0.687, and the coefficient for parity ranged from 0.302 to 0.324 (p ⫽ 0.0004) compared to a baseline of 0.312. Only seven of 178 subjects (3.9%) continued Norplant use to 5 years. Table 5 shows the reasons for removal. Most subjects gave more than one reason, regardless of how long they had used Norplant. Multiple general reasons, such as headache, fatigue, hair loss, nausea, weight changes, breast symptoms, and appetite changes, were frequently reported by terminators in the first 0 – 6-month interval, and only rarely after that. The most common reason categories were menstrual irregularities (44.4%), weight concerns (32.3%), and headache (33.9%). Cramps and untreated menorrhagia were the most common menstrual complaints. Just over one-fourth of subjects complained of weight gain. Hair loss was a reason for just over one-fifth of the women. Social reasons were reported by 20.2% of subjects and included desire for pregnancy (12%), fears about cancer or other ill effects, partner demands for termination, or moving out of state. Only 3.2% had obtained a bilateral tubal ligation before removal of Norplant. Arm complaints such as itching or pain at the implant site, radicular pain from the site of implantation to the wrist, and visibility of the implants occurred in 17.7% of sub-
Table 4. Cox proportional hazards regression analysis of termination rates Variable Total study group* Black race Parity In school Black women† Parity In school Hormonal contracept. Hispanic women‡ Parity
Coefficient
Relative hazard (95% confidence interval)
p value
⫺0.687 0.312 0.373
0.503 (0.339–0.746) 1.366 (1.153–1.618) 1.452 (0.970–2.174)
0.0006 0.0003 0.07
0.212 0.395 ⫺0.636
1.236 (1.024–1.492) 1.484 (0.895–2.463) 0.529 (0.309–0.908)
0.03 0.13 0.02
0.461
1.585 (1.169–2.150)
0.003
Relative hazard ⫽ exponent “e” to the coefficient power. *168 observations, 113 events, 10 missing, Wald ⫽ 0.0001, likelihood ratio ⫽ 0.0001. †110 observations, 69 events, 4 missing, Wald ⫽ 0.009, likelihood ratio ⫽ 0.009. ‡63 observations, 49 events, 1 missing, Wald ⫽ 0.003, likelihood ratio ⫽ 0.004.
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Table 5. Reasons for implant removal Reason Menstrual (44.4%) Amenorrhea Menorrhagia-not treated Menorrhagia-treated Metrorrhagia Cramps Weight (32.3%) Gain Loss Hair loss Breast complaints Headache Acne Arm (17.7%) Pain Rash Other Pregnant at time of insertion Depression Social (20.2%) Desires pregnancy Partner desires pregnancy Had bilateral tubal ligation Other
Number (% of 124 patients) 7 (5.6) 17 (13.7) 10 (8.1) 6 (4.8) 15 (12.1) 34 (27.4) 6 (4.8) 28 (22.6) 5 (4.0) 42 (33.9) 13 (10.5) 15 (12.1) 5 (4.0) 2 (1.6) 4 (3.2) 17 (13.7) 15 (12.1) 2 (1.6) 4 (3.2) 4 (3.2)
There were no statistically significant racial differences in reasons for removal, nor in stated reasons for removal when stratified by 1-year time intervals.
jects. There was one site infection after removal of the implants that was treated successfully with oral erythromycin. Psychologic reasons such as mood changes, depressive symptoms, and anxiety were uncommon reasons for termination.
Discussion The profile of the women who selected Norplant reported here is reflective of the population served by the health center and of most studies about Norplant use in the United States. Most women who chose Norplant were minority women with one or more children. Minority women without children or pregnancy experience rarely chose Norplant. We found that low parity was a significant independent predictor of Norplant continuation, which is consistent with previous reports.8,16,21 The association of increasing parity with early removal of Norplant was stronger for Hispanic women than for black women. Many Hispanic women are from large families and of the Catholic religion, which might influence contraceptive decision-making. Like other researchers, we found significant differences between black and Hispanic women.15,21 Black women were 50% less likely to remove Norplant than the Hispanic women. This finding complements the report by Polaneczky et al. that black women use
Depo-Provera longer than Hispanic women.22 Mean weight at insertion was higher for black women than for Hispanic women. Because obese women produce more exogenous estrogen than thinner women, it would be interesting to determine whether heavier women experience fewer bleeding problems and other side effects than lighter women. With more pregnancy experience, including abortion and miscarriage, slightly more education, and partner relationships of shorter duration, these black women may have had stronger motivation to avoid pregnancy than the Hispanic women. Because using OCs or DepoProvera in the month before Norplant use was a predictor for Norplant continuation for black subjects, it appears that black women already motivated to use a reliable contraceptive before choosing Norplant are good Norplant candidates. We attempted to clarify terminology for duration of use of Norplant. The Norplant package insert reports annual cumulative continuation rates of 80%–93% for year 1, 86%–90% for year 2, and 29.5% for year 5.23 Our reported cumulative continuation rates for every year of use are lower than those previously reported elsewhere except by Ebacher et al., who reported comparable continuation rates in Latina women and rates of 70%, 43%, 28%, and 22% for years 1– 4 of use in teenage women.2,3,5,12,16,18,24 We attribute our lower continuation rates to our low LTFU rate (more complete data), and to the minimal provider barriers to removal at our site.25 We report data for the cohort with 5 years of follow-up, longer than most other reports for American women using the 6-rod implants. Only seven of 178 subjects used Norplant for the full 5 years possible. The 1-year cumulative continuation rate of 68.5% surpasses the 50% reported rate for OCs and the 30% rate for Depo-Provera.1,22 The 10% LTFU rate reported here is the lowest of all studies reviewed. Our continuation rates closely approximate actual use of Norplant over 5 years by this sample of women. Events in LTFU subjects did not significantly differ from other subjects and our continuation rates were minimally changed when we statistically adjusted for either an early or late removal possibility. The reasons for removal of Norplant reported here were the same as reported elsewhere.5,16,26 Hair loss was diagnosed as telogenic effluvium, a diffuse type of alopecia related to an increase in the percentage of hairs that are in the resting phase of growth. It is frequently present in the postpartum state and is considered to be a reversible condition. Arm complaints were more common than expected, as arm pain was rarely mentioned in the early reports.5,27 Dizziness and depression were not significant reasons
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for removal in our study.5,28,29 Preinsertion counseling about common side effects and strategies to cope, including tampon use, appetite awareness, and overthe-counter medications, are an important aspect of providing this method. There are several limitations in this study, including the lack of a comparison group of women using other contraceptive methods and a potential bias in preinsertion counseling to select women seeking at least 3 years of contraception. The findings reported here should not be generalized to those who are not black or Hispanic inner-city women of low income status. Further research is needed to explore contraceptive decision-making about Norplant and other long-acting methods for Asian and white women, and for middle-class suburban women. Because 2–3 years is the interval of use chosen by most Norplant users in our study, the newer twocapsule formulation, with its 3-year effectiveness, would be a useful option. Infrequent clinic visits by Norplant users suggests these women may need reminders for Papanicolaou smears and other health screenings, as “they are not held hostage to their method” for receiving annual examinations.12 Continuation rates for Norplant may be lower than previous studies indicated, but are still impressive compared with the continuation rates of other hormonal methods. Minority women successfully using OC or injectables need to know about Norplant, because they are the most likely candidates for satisfied, long-term use. In future studies of newer contraceptives, a comparison of subjects by age, race, and parity is recommended, and LTFU subjects need inclusion in the analyses. More studies are needed about contraceptive decision-making by women and their partners, and about their motivations to be pregnant or not pregnant.
Acknowledgments We thank Karen L. Bossolt, medical student, summer 1994 for her assistance. The project was partially supported from a grant for pre-doctoral training in Family Medicine from the US Department of Health and Human Services. The Norplant Foundation provided free kits for those women without resources otherwise.
References 1. Potter L, Oakley D, de Leon-Wong E, Canamar R. Measuring compliance among oral contraceptive users. Fam Plann Perspec 1996;28:154 – 8. 2. Darney PD. Hormonal implants: contraception for a new century. Am J Obstet Gynecol 1994;170:1536 – 43.
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3. Kaunitz AM. Long-acting contraceptive options. Int J Fertil 1996;41:69 –76. 4. Post SG. Implantable hormonal contraceptive: emerging controversy. Obstet Gynecol 1994;84:1055–7. 5. Shoupe D, Mishell DR. Norplant: subdermal implant system for long-term contraception. Am J Obstet Gynecol 1989;160:1286 –95. 6. Shoupe D, Mishell DR, Bopp BL, Fielding M. The significance of bleeding patterns in Norplant users. Obstet Gynecol 1991;72:256 – 60. 7. Berenson AB, Weimann CM. Patient satisfaction and side effects with levonorgestrel implant (Norplant) use in adolescents 18 years of age or younger. Pediatrics 1993;92:257– 60. 8. Eilers G, Swanson T. Women’s satisfaction with Norplant as compared with oral contraceptives. J Fam Pract 1994;38:596 – 600. 9. Clarke LL, Schmit K, Bono C, Steele J, Miller M. Norplant selection and satisfaction among low-income women. Am J Public Health 1998;88:1175– 81. 10. Crosby UD, Schartz BE, Heartwell S. A preliminary report of Norplant implant insertions in a large urban family planning program. Contraception 1993;48: 359 – 66. 11. Cullins V, Blumenthal P, Remsburg R, Huggins G. Preliminary experience with Norplant in an inner-city population. Contraception 1993;47:193–203. 12. Cullins VE, Remsburg R, Blumenthal P, Huggins G. Comparison of adolescent and adult experiences with Norplant levonorgestrel contraceptive implants. Obstet Gynecol 1994;83:1026 –32. 13. Cushman LF, Davidson A, Kalmuss D, Heartwell S, Rulin M. Beliefs about Norplant implants among lowincome urban women. Contraception 1996;53:285–91. 14. Darney PD, Atkinson E, Turner S, MacPherson S, Hellerstein S, Alvarado A. Acceptance and perceptions of Norplant among users in San Francisco, USA. Stud Fam Plann 1990;21:152– 60. 15. Frank M, Poindexter A, Johnson M, Bateman L. Characteristics and attitudes of early contraceptive implant acceptors in Texas. Fam Plann Perspec 1992;24:208 –13. 16. Frank ML, Poindexter A III, Cornin L, Cox C, Bateman L. One year experience with subdermal contraceptive implants in the United States. Contraception 1993;48: 229 – 43. 17. Haugen MM, Evans C, Kim M. Patient satisfaction with a levonorgestrel-releasing contraceptive implant—reasons for and patterns of removal. J Reprod Med 1996;41:849 –54. 18. Kalmuss D, Davidson A, Cushman L, Heartwell S, Rulin M. Determinants of early implant discontinuation among low-income women. Fam Plann Perspec 1996;28:256 –9. 19. Rickets SA. Repeat fertility and contraceptive implant use among Medicaid recipients in Colorado. Fam Plann Perspec 1996;28:278 – 80. 20. Suman V, Van Winter J, Evans M, Simmons P, Jacobsen S, Manolis A. Levonorgestrel contraceptive implants in female patients 14 –21 years old. Mayo Clin Proc 1998; 73:10 – 6. 21. Weisman CS, Plichta S, Tirado D, Dana K. Comparison of contraceptive implant adopters and pill users in a family planning clinic in Baltimore. Fam Plann Perspec 1993;25:224 – 6.
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22. Polaneczky M, Guarnaccia M, Alon J, Wiley J. Early experiences with the contraceptive use of depomedroxyprogestereone acetate in an inner-city clinic population. Fam Plann Perspec 1996;28:174 – 8. 23. Wyeth Laboratories I. Norplant package insert. 1990. 24. Ebacher R, Prior S, Valdini A. Norplant utilization in a Latina inner-city population. J Health Care Poor & Underserved 1999;10:85–99. 25. Kalmuss D, Davidson A, Cushman L, Heartwell S, Rulin M. Potential barriers to the removal of Norplant among family planning clinic patients. Am J Public Health 1998;88:1846 –9. 26. Diaz S, Pavez M, Miranda P, Robertson D, Sivin I,
Contraception 2000;61:83–90
Croxatto H. A five-year clinical trial of levonorgestrel Silastic implants (Norplant). Contraception 1982;25: 447–56. 27. Akhter H, Dunson TR, Amatya RN, et al. A five-year clinical evaluation of Norplant威 contraceptive subdermal implants in Bangladeshi acceptors. Contraception 1993;47:569 – 82. 28. Wagner KD, Berenson AB. Norplant-associated major depression and panic disorder. J Clin Psychiatry 1994; 55:478 – 80. 29. Wagner KD. Major depression and anxiety disorder associated with Norplant. J Clin Psychiatry 1996;57: 152–7.