Use of Norplant® implants in asymptomatic HIV-1 infected women

ELSEVIER

Use of AsYmP

.t@Imp lants in HIV- 1 Infec ‘ted Women

Surasak Taneepanichskul, Suwachai and Kamhaeng Chaturachinda

Intaraprasert,

The study of Norplant@ implants use in HIV-1 infected women was conducted at the Family Planning Clinic, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, from January 1993 to /une 1996. The purpose of the study was to evaluate efficacy, clinical effects, side effects, and menstrual patterns of the Norplant system in HIV-l infected acceptors. Forty-one cases of asymptomatic HIV-1 positive women voluntarily participated in using Norplant implants after delivery or abortion. The mean age was 25.4 years. The most common menstrual pattern was irregular bleeding (63.4%). Mean blood pressure, body weight, and hemoglobin level were not different at insertion and at 12 months (p > 0.05). No pregnancy occurred during a 12month period. It was concluded that the Norplant system was safe, efficacious, and well tolerated in HIV-1 positive women and is an appropriate contraception in these women. CONTRACEPTION 1997;55:205-207 0 1997 Elsevier Science Inc. All rights reserved.

Norplant implant, HIV, efficacy, menstrual patterns, side effects

KEY WORDS:

Introduction he epidemic of HIV infection in reproductive age women is a major public health problem. In Thailand, the prevalence of HIV-positive pregnant women was 2% in 1993.’ HIV infected babies have increased in number via vertical transmission. Contraception in this population plays an important role in the prevention and control of this problem. The Nor-plant implants, a long-acting lowdose progestin-only and long-term reversible contraceptive, in HIV infected women are able to prevent a

T

Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand Name and address for correspondence: Dr. Surasak Taneepanichskul, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Rama VI Road, Bangkok 10400, Thailand. Tel: 022455828; Fax: 66-2-2011416 Submitted for publication September 2, 1996 Revised December 16, 1996 Accepted for publication December 30, 1996 Norplant@ is a registered trademark of the Population Council, Inc.

0 1997 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010

Winit Phuapradit,

number of babies with AIDS. The National Family Planning Program of Thailand introduced Nor-plant implants in 1986. However, only a few HIV positive women use this method and little knowledge exists about Norplant implants efficacy and clinical effects. The purpose of the study was to evaluate efficacy, clinical effects, side effects, and menstrual patterns of the Norplant system during a one-year follow-up period in asymptomatic HIV-1 infected women.

Materials

and Methods

This cohort study was performed at the Family Planning Clinic, Ramathibodi Hospital, an 800-bed university hospital in Bangkok, from January 1993. Asymptomatic HIV infected women were eligible for enrollment in this study. 2 The subjects voluntarily desired Nor-plant implants for contraception, were postpartum or post abortion within 4 weeks, had no contraindication to Norplant implants insertion, and had hemoglobin values of 210 gm/dl. Excluded from the study were women with a history of bleeding disorders, hypertension, and those who could not be followed-up during the one-year period or who had lost contact. From January 1993 through June 1996, there were 43 asymptomatic HIV-l positive women who voluntarily used Norplant implants for contraception after delivery and abortion. However, two cases had lost contact. Only 41 cases were eligible and participated in the study. Twelve cases were postpartum and 29 cases were post abortion. Each acceptor was given counseling and full explanation of the method, and was informed of the study process by a nurse and/or a clinical staff of the family planning clinic. All acceptors received Norplant implants insertion within 4 weeks after delivery or abortion. Follow-up visits were scheduled for the first week, third month, sixth month, and twelfth month after implants placement. All acceptors enrolled in the study had physical and pelvic examination, CD4 count, hemoglobin, weight, and blood pressure recorded at initial visit before Norplant implants insertion. At each follow-up visit, they were given a physical and pelvic examination including weight ISSN OOlO-7824/97/$17.00 PII s0010-7824(97)00011-5

206

Taneepanichskul

et al.

Contraception 1997;55:205-207

1. Characteristics of asymptomatic HIV-l infected Norplant implants acceptors

Table

Variable

Menstrual Pattern

6 Months

12 Months

Amenorrhea (3 months) Irregular bleeding Regular cycle

10 (24.4%) 2; [;;.;y . Or3

15 (36.6%) 2; [;";y' . Oo

Total

41

41

Table

Age (years) Body weight at insertion (kg) Blood pressureat insertion Systolic (mm Hg) Diastolic (mm Hg) Education Primary (% ) Secondary (%) Above secondary (%) Occupation Housewife (%) Employee (%) Others (%) Most recent contraception Oral pill (%) Injection (%) Condom 1%) None 1%) CD4 count CD4 >200 cells/k1 (%) CD4 ~200 cells/j.rl (%) Hemoglobin (g/dl)

N = 41 cases

95% CI

25.4 2 4.7 48.3 + 5.1

23.9, 26.9 46.7, 49.9

116.3 + 6.6 75.1 + 5.1

114,118 73.5, 76.7

41.5 48.8 9.8

26.3, 57.9 32.9, 64.9 2.7, 23.1

48.8 39 12.2

32.9, 64.9 24.2, 55.5 4.1, 26.2

19.5 9.8 7.3 63.4

8.8,34.9 2.7, 23.1 1.5, 19.9 46.9, 77.9

75.6 24.4 11.3 + 0.8

59.7, 87.6 12.4, 40.3

11.0, 11.6

2. Menstrual patterns of asymptomatic HIV-l fected acceptors

in-

mm Hg (minimum 110 mm Hg and maximum 130 mm Hg), while the mean diastolic blood pressure at insertion was 75.1 + 5.1 mm Hg [minimum 70 mm Hg and maximum 80 mm Hg). Most of the acceptors (48.8%) had completed secondary school and the major occupation was housewife (48.8%). More than half of the acceptors (63.4%) had not used any contraception prior to pregnancy. The contraceptive methods used by these acceptors prior to pregnancy were oral pill (19.5%), injection (9.8%), and condom (7.3%). Most of them (75.6%) had CD4 count >200 cell/pi and mean hemoglobin was 11.3 ? 0.8 g/dl. Insertion time averaged 10 min. There were no complications with the insertion procedure.

and blood pressure, and vaginal bleeding episodes were recorded. Side effects and their reaction were assessed. They used no other contraceptive except condom during the study period. Telephone calls and letters were used in case of missed appointment. Insertion of Norplant implants was performed by the staff of the family planning unit. Amenorrhea is defined as the absence of menstruation for 3 months or longer. Regular cycle is a periodic withdrawal bleeding within 28 + 7 days. Irregular cycles are defined as intermenstrual, prolonged, or heavy bleeding at irregular intervals. The descriptive and analytic statistics were run on all data where appropriate. SPSS/PC+ for windows, a statistical package, was used to analyze data. All data were coded, recorded, and analyzed by the authors. The descriptive statistics were percentage, mean, standard deviation, and 95% confidence interval. The statistical analyses were performed using the paired t-test for comparison of means. A statistical significance was expressed at the level of 0.05 for all analyses.

Results The characteristics of the asymptomatic HIV-l infected acceptors are shown in Table 1. All acceptors were primigravida. The mean age was 25.4 + 4.7 years; minimum 14 years and maximum 36 years. The mean body weight at insertion was 48.3 + 5.1 kg; minimum 39 kg and maximum 60.2 kg. The mean systolic blood pressure at insertion was 116.3 ? 6.6

Considering

the menstrual

patterns,

most

of the

bleeding patterns at 6 and 12 months were irregular

bleeding, followed by amenorrhea (Table 2). The major side effects reported at 6 and 12 months of follow-up were nausea, headache, anorexia, acne, and chloasma (Table 3). By using paired t-test, there were no significant differences in body weight, blood pressure, and hemoglobin at the time of insertion and at the one-year follow-up (Table 4). No pregnancy occurred in these acceptors during the study period.

Discussion Previous studies have shown Norplant implants a safe and effective method of contraception.3f4

to be How-

3. Reported side effects of asymptomatic HIV-l infected Norplant implants acceptors Table

Side Effect Nausea Yes No Headache Yes No Anorexia Yes No Acne/chloasma Yes No

6 Months

12 Months

5 (12.2%) 36(87.8%)

3(7.7%) 38 (92.7%)

10 (24.4%) 31(75.6%)

6 (14.6%) 35 (85.4%)

6(14.6%) 35 (85.4%)

4( 9.8%) 37 (90.2%)

7 (17.1%) 34 (82.9%)

9 (21.9%) 32 (78.1%)

Contraception 1997;55:205-207

Norplant

Table 4. Comparison of body weight, blood pressure,and hemoglobin at insertion and 12-month follow-up Variable

At Insertion N = 41

12 Months N = 41

p-Value

Body weight (kg) Blood pressure Systolic (mm Hg) Diastolic (mm Hg) Hemoglobin (g/dl)

48.3

116.3 75.1 11.3

SD Mean SD 5.1 48.1 5.03 p > 0.05 6.6 5.1 0.8

ever, most studies evaluating

117.1 5.6

p > 0.05 p > 0.05 11.1 1.2 p > 0.05 74.9

5.1

the use of Norplant

implants were in non-HIV infected women. With increase in HIV infected babies via vertical transmission, permanent and long-acting contraceptive methods in HIV infected parturients are able to prevent a number of babies from developing AIDS. The Norplant implants, a long-acting progestin contraceptive system, should be an appropriate method for HIV infected women in preventing pregnancy. However, safety and effectiveness of the Norplant system in this population should be evaluated. This study revealed that most of the HIV infected Norplant implants acceptors had CD4 count more than 200 cells/ ul. The most common menstrual pattern was irregular bleeding followed by amenorrhea; this finding is no different from the non-HIV infected acceptor.3f4 The side effects were headache, acne, chloasma, anorexia, and nausea. These side effects were not different from those in the non-HIV acceptor415 Considering body weight at insertion and 12month follow-up, it was revealed that average body weight at 12 months was slightly lower than at insertion, but not statistically significant. This result was the same as that found in non-HIV acceptors.” Mean systolic and diastolic blood pressures were not different at insertion and 12-month follow-up. Even though irregular bleeding was the most common menstrual pattern and side effect, this study showed

Use in HIV-l

no difference statistically

at insertion

Infected

Women

207

in mean hemoglobin level

and 12 months.

However,

the average

hemoglobin level at 12 months was slightly lower than at insertion. This finding might be the result of

irregular Mean

Implants

bleeding

but was not of statistical

or clinical

significance. The efficacy of Norplant implants in preventing pregnancy during the first year was good among asymptomatic HIV infected acceptors because no pregnancy occurred during this study period. In conclusion, this study reveals that Norplant implants use in asymptomatic HIV infected women appears to be efficacious and well tolerated. The menstrual patterns and occurrence of known side effects do not appear to differ from non-HIV acceptors. There are also non-significant changes in body weight, blood pressure, and hemoglobin level during a

one-year period. We recommend as an appropriate contraceptive

the Norplant system method for asymp-

tomatic HIV infected women who want to have long-term contraception and do not wish to choose sterilization.

References 1. Taneepanichskul S. Prevalence of HIV-l positive moth-

ers in Thailand 1990-1993. J Obstet Gynaecol 1995j21 (suppl 1):207. 2. 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescent and adults. Morbid Mortal Weekly Rept 1992; 41:1-17. 3. Taneepanichskul S. First year’s experience with Nor-

plant. Thai J Obstet Gynaecol 1989;1:71-5. 4. Chompootaweep S, Kochagarn E, Sirisumpan S, Tang-

Usaha J, Theppitaksak B, Dusitsin N. Effectiveness of Norplant implants among Thai women in Bangkok. Contraception 1996j53:33-6. 5. Phemister DA, Laurent S, Harrison FNH. Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance. Am J Obstet Gynaecol 1995j172:175-9. 6. Moore L, Valuck R, McDougall C, Fink W. A comparison study of one-year weight gain among users of medroxyprogesterone acetate, levonorgestrel implants and oral contraceptives. Contraception 1995;52:215-20.