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Use of Norplant implants in the immediate postpartum period among asymptomatic HIV-1-positive mothers
Contraception 64 (2001) 39 – 41
Original research article
Use of Norplant implants in the immediate postpartum period among asymptomatic HIV-1-positive mothers Surasak Taneepanichskul*, Chamnan Tanprasertkul Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Abstract A prospective cohort study of Norplant use in the immediate postpartum period among asymptomatic HIV-1-positive women was conducted in Bangkok, Thailand. The objectives of this study were to evaluate side effects and menstrual patterns of the Norplant system in this group. A total of 88 asymptomatic HIV-1-positive mothers were recruited for this study. All of them voluntarily accepted the use of the Norplant implant as a contraceptive method immediately postpartum. Their mean age was 24.9 years. Most of them had completed primary school. The follow-up period was 24 weeks. There were eight participants lost from the study because of loss of contact. Irregular bleeding was the most common menstrual pattern in these participants. The major side effects were headache, followed by hair loss. No subject terminated Norplant use during the study period. The Norplant implant appears to be safe and well tolerated in asymptomatic HIV-1-positive parturients when inserted immediately postpartum. © 2001 Elsevier Science Inc. All rights reserved. Keywords: Norplant; Immediate postpartum; HIV-1-positive mothers
1. Introduction
2. Materials and methods
The epidemic of HIV infection in reproductive-aged women is a major public health problem [1]. The prevalence of HIV-positive mothers is increasing in developing countries [2]. HIV-infected babies have also increased in number because of vertical transmission [1]. Contraception in this population plays an important role in the prevention and control of HIV transmission [1]. The use of Norplant (Wyeth-Ayerst Laboratories, Philadelphia, USA), a longlasting reversible contraceptive method consisting of subdermal implants of Silastic capsules containing levonorgestrel, in HIV-infected women has been shown to be effective [1]. Immediate postpartum insertion of Norplant appears to be a safe and effective method of contraception in normal women [3,4]. However, no data are available concerning HIV-positive women who use Norplant immediately postpartum. The objective of this study was to evaluate side effects and menstrual patterns associated with the Norplant system when inserted immediately postpartum in HIV-1-positive mothers.
This cohort study was performed at the Family Planning Clinic, King Chulalongkorn Memorial Hospital, Bangkok, Thailand, from May 1998 to April 1999. Asymptomatic HIV-1-infected women were eligible for enrollment in this study [5]. Other inclusion criteria were gestational age at delivery more than 37 complete weeks; birth weight ⱖ2,500 g; no complications during the antepartum, intrapartum, and postpartum periods; and no breastfeeding. Excluded from the study were women with a history of bleeding disorders, hypertension, and those who could not be followed up during the study period. The participants voluntarily chose Norplant implants for contraception and had no contraindications for this. Norplant insertion was performed within 48 h of delivery, and the participants were followed for 24 weeks postpartum. A total of 88 participants were recruited, and 80 cases completed follow-up. The drop-out rate was 10%. Follow-up visits were scheduled for the first week at and 4, 12, and 24 weeks after implant placement. All participants enrolled in the study had physical and pelvic examination, weight and blood pressure recorded on postpartum Day 2 and again at the 4, 12, and 24 weeks follow-up visit. Once discharged from the hospital, each subject maintained a diary in which she recorded the days of vaginal bleeding, the intensity of the flow, and the incidence of any
* Corresponding author. Tel.: ⫹66256-4241; fax: ⫹66254-9292. E-mail address: [email protected] (S. Taneepanichskul).
0010-7824/01/$ – see front matter © 2001 Elsevier Science Inc. All rights reserved. PII: S 0 0 1 0 - 7 8 2 4 ( 0 1 ) 0 0 2 1 6 - 5
40
S. Taneepanichskul, C. Tanprasertkul / Contraception 64 (2001) 39 – 41
Table 1 Characteristics of asymptomatic HIV-1-positive participants
Table 3 Reported side effects at the 24 week follow-up visit of asymptomatic HIV-1 infected participants
Characteristics Age (year, mean ⫾ SD) Height (cm, mean ⫾ SD) Weight at insertion (kg, mean ⫾ SD) Body mass index (kg/m2, mean ⫾ SD) Occupation Homemaker Employee Business Education Illiterate Primary Secondary Undergraduate Parity 1 2 3 4
24.9 ⫾ 4.5 152.2 ⫾ 6.1 51.4 ⫾ 6.7 22.2 ⫾ 3.1 49 cases (55.7%) 33 cases (37.5%) 6 cases (6.8%) 7 57 23 1
cases (8%) cases (64.8%) cases (26.1%) cases (1.1%)
47 35 5 1
cases (53.4%) cases (39.8%) cases (5.7%) cases (1.1%)
side effects. An irregular cycle was defined as intermenstrual, prolonged, or heavy bleeding at irregular intervals. Amenorrhea was defined as the absence of menstruation for 3 months or longer. A regular cycle was defined as periodic withdrawal bleeding within 28 ⫾ 7 days.
3. Results Eighty-eight asymptomatic HIV-1-positive women were recruited into the study. The characteristics of the participants are shown in Table 1. No patient had any episode of acute postpartum hemorrhage or complications from the Norplant insertion. To evaluate bleeding patterns and side effects, each patient had her completed diary collected at the 24 weeks follow-up visit. Eighty participants completed their follow-up visits, and eight acceptors were lost to contact. As shown in Table 2, the most common bleeding pattern was irregular bleeding (50 cases). Side effects were determined from the women’s reporting of side effects in the diaries during the time interval from of date of discharge to date of last follow-up visit. Most participants had no reported side effects. However, there were 24 cases with some side effects, the details of which are shown in Table 3. No subject terminated Norplant use during the study period.
Table 2 Menstrual patterns from 4 to 24 weeks post Norplant insertion Bleeding patterns
Number (cases)
%
95% CI
Irregular cycle Amenorrhea Regular cycle Total
50 26 4 80
62.5 32.5 5.0 100.0
51, 73.1 22.4, 43.9 1.3, 12.3
Side effect Headache Yes No Hair loss Yes No Nausea Yes No Acne/cholasma Yes No
Number (case)
Percent
95% CI
10 70
12.5 87.5
6.2, 21.8 78.2, 93.8
7 73
8.7 91.3
3.6, 17.2 82.8, 96.4
4 76
5.0 95.0
1.4, 12.3 87.7, 98.6
3 77
3.8 96.2
0.8, 10.6 89.4, 99.2
4. Discussion The Norplant implant is a safe and effective method of contraception. However, most studies evaluating the use of Norplant implants have examined non-HIV-infected women, and, in cases of postpartum women, the use of Norplant has been studied at around 6 weeks after delivery. The experiences of these women have been well documented in previous studies [6 – 8]. Taneepanichskul et al. [1] reported that the use of the Norplant implant in asymptomatic HIV-1-infected women appeared to be safe, efficacious, and well tolerated. However, the Norplant implants were not inserted in the postpartum period. Although, there have been a few studies of Norplant insertion in the immediate postpartum period [3,4], no study on HIV-1-infected women has been reported. Phemister et al. and Molland et al. found that a Norplant inserted in the immediate postpartum period appeared to be safe and well tolerated, and the side effects did not appear to differ from the use of Norplant for nonpregnancy related contraception [3,4]. In this study, it was revealed that there were no complications after Norplant insertion. The menstrual patterns after immediate postpartum insertion of Norplant HIV-1-positive women were not different from those in the nonpostpartum period [1]. Irregular bleeding was the most common pattern in Norplant acceptors, and regular cycle was the least [1]. Considering side effects, headache was the most commonly reported side effect at the 12 week follow-up visit, which was similar to the picture in non-HIV-1-infected postpartum Norplant acceptors [3]. The advantage of immediate postpartum insertion of Norplant is that it enables women with HIV infection to leave the hospital with their contraceptive method of choice already in place. With the increase in numbers of HIVinfected mothers, particularly in developing countries, there have been a greater number of HIV-infected babies because of vertical transmission [1]. The use of long-acting contraceptive methods, such as Norplant, in HIV-infected parturients will reduce the number of babies with HIV infection.
S. Taneepanichskul, C. Tanprasertkul / Contraception 64 (2001) 39 – 41
Early ovulation is to be expected in HIV-infected parturients because they are recommended not to breastfeed to avoid HIV transmission to their babies via breast milk. Gray et al. reported that 50% of nonbreastfeeding women had some luteal phase activity before 6 weeks postpartum [9]. Moreover, an earlier study indicated that 40% of parturients had resumed sexual activity when they returned for their 4 to 6 weeks follow-up examination [3]. Considering this evidence, the use of Norplant implants immediately postpartum, before leaving the hospital, is a rational approach to prevent further pregnancy among asymptomatic HIV-1-positive women. This study showed that menstrual patterns following immediate postpartum insertion were not greatly different from that following interval insertion. Irregular bleeding was the most common pattern, followed by regular cycle and amenorrhea in both groups [1]. Most of the immediate postpartum acceptors had no side effects. The most common side effect was headache, which was similar to the picture in interval insertion acceptors and was not different from that in non-HIV-infected Norplant users [1,3]. In conclusion, this study reveals that use of Norplant in the immediate postpartum period in asymptomatic HIV-1infected women appears to be safe and well tolerated. The menstrual patterns were not different from HIV-1-positive interval insertion acceptors [1]. The occurrence of known side effects does not appear to differ from previous studies that investigated the use of Norplant for non-HIV-infected immediate postpartum insertion parturients [3,4]. We suggest that the Norplant system can be used for immediate
41
postpartum insertion in HIV-positive parturients who want to have long-term contraception and are not certain to return for postpartum follow-up visits. However, Norplant will not prevent HIV transmission to their partners. Use of condom should be strongly recommended with these patients.
References [1] Taneepanichskul S, Intaraprasert S, Phuapradit W, Chaturachinda K. Use of Norplant® implants in asymptomatic HIV-1 infected women. Contraception 1997;55:205–7. [2] Taneepanichskul S. Prevalence of HIV-1 positive mothers in Thailand 1990 –1993. J Obstet Gynaecol 1995;21(Suppl):207. [3] Phemister DA, Laurent S, Harrison FNH. Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance. Am J Obstet Gynecol 1995;172:175–9. [4] Molland JR, Castracave VD, Morehead DB, Castley B, Baldwin DM, Bergquist CA. Immediate postpartum insertion of the Norplant contraceptive device. Fertil Steril 1996;66:43– 8. [5] 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. [6] Taneepanichskul S. First year’s experience with Norplant. Thai J Obstet Gynaecol 1989;1:71–5. [7] Chomprotaweep S, Kochagarn E, Sirisumpan S, Tang-Usaha J, Theppitakjak B, Dusitsin N. Effectiveness of Norplant implants among Thai women in Bangkok. Contraception 1996;53:33– 6. [8] Shoupe D, Mishell DR. Norplant: subdermal implant system for longterm contraception. Am J Obstet Gynecol 1989;160:1286 –92. [9] Gray RH, Campbell OM, Zacur HA, Labbok MH, MacRae SL. Postpartum return of ovarian activity in non-breastfeeding women monitored by urinary assays. J Clin Endocrinol Metab 1987;64:645–50.
Original research article
Use of Norplant implants in the immediate postpartum period among asymptomatic HIV-1-positive mothers Surasak Taneepanichskul*, Chamnan Tanprasertkul Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Abstract A prospective cohort study of Norplant use in the immediate postpartum period among asymptomatic HIV-1-positive women was conducted in Bangkok, Thailand. The objectives of this study were to evaluate side effects and menstrual patterns of the Norplant system in this group. A total of 88 asymptomatic HIV-1-positive mothers were recruited for this study. All of them voluntarily accepted the use of the Norplant implant as a contraceptive method immediately postpartum. Their mean age was 24.9 years. Most of them had completed primary school. The follow-up period was 24 weeks. There were eight participants lost from the study because of loss of contact. Irregular bleeding was the most common menstrual pattern in these participants. The major side effects were headache, followed by hair loss. No subject terminated Norplant use during the study period. The Norplant implant appears to be safe and well tolerated in asymptomatic HIV-1-positive parturients when inserted immediately postpartum. © 2001 Elsevier Science Inc. All rights reserved. Keywords: Norplant; Immediate postpartum; HIV-1-positive mothers
1. Introduction
2. Materials and methods
The epidemic of HIV infection in reproductive-aged women is a major public health problem [1]. The prevalence of HIV-positive mothers is increasing in developing countries [2]. HIV-infected babies have also increased in number because of vertical transmission [1]. Contraception in this population plays an important role in the prevention and control of HIV transmission [1]. The use of Norplant (Wyeth-Ayerst Laboratories, Philadelphia, USA), a longlasting reversible contraceptive method consisting of subdermal implants of Silastic capsules containing levonorgestrel, in HIV-infected women has been shown to be effective [1]. Immediate postpartum insertion of Norplant appears to be a safe and effective method of contraception in normal women [3,4]. However, no data are available concerning HIV-positive women who use Norplant immediately postpartum. The objective of this study was to evaluate side effects and menstrual patterns associated with the Norplant system when inserted immediately postpartum in HIV-1-positive mothers.
This cohort study was performed at the Family Planning Clinic, King Chulalongkorn Memorial Hospital, Bangkok, Thailand, from May 1998 to April 1999. Asymptomatic HIV-1-infected women were eligible for enrollment in this study [5]. Other inclusion criteria were gestational age at delivery more than 37 complete weeks; birth weight ⱖ2,500 g; no complications during the antepartum, intrapartum, and postpartum periods; and no breastfeeding. Excluded from the study were women with a history of bleeding disorders, hypertension, and those who could not be followed up during the study period. The participants voluntarily chose Norplant implants for contraception and had no contraindications for this. Norplant insertion was performed within 48 h of delivery, and the participants were followed for 24 weeks postpartum. A total of 88 participants were recruited, and 80 cases completed follow-up. The drop-out rate was 10%. Follow-up visits were scheduled for the first week at and 4, 12, and 24 weeks after implant placement. All participants enrolled in the study had physical and pelvic examination, weight and blood pressure recorded on postpartum Day 2 and again at the 4, 12, and 24 weeks follow-up visit. Once discharged from the hospital, each subject maintained a diary in which she recorded the days of vaginal bleeding, the intensity of the flow, and the incidence of any
* Corresponding author. Tel.: ⫹66256-4241; fax: ⫹66254-9292. E-mail address: [email protected] (S. Taneepanichskul).
0010-7824/01/$ – see front matter © 2001 Elsevier Science Inc. All rights reserved. PII: S 0 0 1 0 - 7 8 2 4 ( 0 1 ) 0 0 2 1 6 - 5
40
S. Taneepanichskul, C. Tanprasertkul / Contraception 64 (2001) 39 – 41
Table 1 Characteristics of asymptomatic HIV-1-positive participants
Table 3 Reported side effects at the 24 week follow-up visit of asymptomatic HIV-1 infected participants
Characteristics Age (year, mean ⫾ SD) Height (cm, mean ⫾ SD) Weight at insertion (kg, mean ⫾ SD) Body mass index (kg/m2, mean ⫾ SD) Occupation Homemaker Employee Business Education Illiterate Primary Secondary Undergraduate Parity 1 2 3 4
24.9 ⫾ 4.5 152.2 ⫾ 6.1 51.4 ⫾ 6.7 22.2 ⫾ 3.1 49 cases (55.7%) 33 cases (37.5%) 6 cases (6.8%) 7 57 23 1
cases (8%) cases (64.8%) cases (26.1%) cases (1.1%)
47 35 5 1
cases (53.4%) cases (39.8%) cases (5.7%) cases (1.1%)
side effects. An irregular cycle was defined as intermenstrual, prolonged, or heavy bleeding at irregular intervals. Amenorrhea was defined as the absence of menstruation for 3 months or longer. A regular cycle was defined as periodic withdrawal bleeding within 28 ⫾ 7 days.
3. Results Eighty-eight asymptomatic HIV-1-positive women were recruited into the study. The characteristics of the participants are shown in Table 1. No patient had any episode of acute postpartum hemorrhage or complications from the Norplant insertion. To evaluate bleeding patterns and side effects, each patient had her completed diary collected at the 24 weeks follow-up visit. Eighty participants completed their follow-up visits, and eight acceptors were lost to contact. As shown in Table 2, the most common bleeding pattern was irregular bleeding (50 cases). Side effects were determined from the women’s reporting of side effects in the diaries during the time interval from of date of discharge to date of last follow-up visit. Most participants had no reported side effects. However, there were 24 cases with some side effects, the details of which are shown in Table 3. No subject terminated Norplant use during the study period.
Table 2 Menstrual patterns from 4 to 24 weeks post Norplant insertion Bleeding patterns
Number (cases)
%
95% CI
Irregular cycle Amenorrhea Regular cycle Total
50 26 4 80
62.5 32.5 5.0 100.0
51, 73.1 22.4, 43.9 1.3, 12.3
Side effect Headache Yes No Hair loss Yes No Nausea Yes No Acne/cholasma Yes No
Number (case)
Percent
95% CI
10 70
12.5 87.5
6.2, 21.8 78.2, 93.8
7 73
8.7 91.3
3.6, 17.2 82.8, 96.4
4 76
5.0 95.0
1.4, 12.3 87.7, 98.6
3 77
3.8 96.2
0.8, 10.6 89.4, 99.2
4. Discussion The Norplant implant is a safe and effective method of contraception. However, most studies evaluating the use of Norplant implants have examined non-HIV-infected women, and, in cases of postpartum women, the use of Norplant has been studied at around 6 weeks after delivery. The experiences of these women have been well documented in previous studies [6 – 8]. Taneepanichskul et al. [1] reported that the use of the Norplant implant in asymptomatic HIV-1-infected women appeared to be safe, efficacious, and well tolerated. However, the Norplant implants were not inserted in the postpartum period. Although, there have been a few studies of Norplant insertion in the immediate postpartum period [3,4], no study on HIV-1-infected women has been reported. Phemister et al. and Molland et al. found that a Norplant inserted in the immediate postpartum period appeared to be safe and well tolerated, and the side effects did not appear to differ from the use of Norplant for nonpregnancy related contraception [3,4]. In this study, it was revealed that there were no complications after Norplant insertion. The menstrual patterns after immediate postpartum insertion of Norplant HIV-1-positive women were not different from those in the nonpostpartum period [1]. Irregular bleeding was the most common pattern in Norplant acceptors, and regular cycle was the least [1]. Considering side effects, headache was the most commonly reported side effect at the 12 week follow-up visit, which was similar to the picture in non-HIV-1-infected postpartum Norplant acceptors [3]. The advantage of immediate postpartum insertion of Norplant is that it enables women with HIV infection to leave the hospital with their contraceptive method of choice already in place. With the increase in numbers of HIVinfected mothers, particularly in developing countries, there have been a greater number of HIV-infected babies because of vertical transmission [1]. The use of long-acting contraceptive methods, such as Norplant, in HIV-infected parturients will reduce the number of babies with HIV infection.
S. Taneepanichskul, C. Tanprasertkul / Contraception 64 (2001) 39 – 41
Early ovulation is to be expected in HIV-infected parturients because they are recommended not to breastfeed to avoid HIV transmission to their babies via breast milk. Gray et al. reported that 50% of nonbreastfeeding women had some luteal phase activity before 6 weeks postpartum [9]. Moreover, an earlier study indicated that 40% of parturients had resumed sexual activity when they returned for their 4 to 6 weeks follow-up examination [3]. Considering this evidence, the use of Norplant implants immediately postpartum, before leaving the hospital, is a rational approach to prevent further pregnancy among asymptomatic HIV-1-positive women. This study showed that menstrual patterns following immediate postpartum insertion were not greatly different from that following interval insertion. Irregular bleeding was the most common pattern, followed by regular cycle and amenorrhea in both groups [1]. Most of the immediate postpartum acceptors had no side effects. The most common side effect was headache, which was similar to the picture in interval insertion acceptors and was not different from that in non-HIV-infected Norplant users [1,3]. In conclusion, this study reveals that use of Norplant in the immediate postpartum period in asymptomatic HIV-1infected women appears to be safe and well tolerated. The menstrual patterns were not different from HIV-1-positive interval insertion acceptors [1]. The occurrence of known side effects does not appear to differ from previous studies that investigated the use of Norplant for non-HIV-infected immediate postpartum insertion parturients [3,4]. We suggest that the Norplant system can be used for immediate
41
postpartum insertion in HIV-positive parturients who want to have long-term contraception and are not certain to return for postpartum follow-up visits. However, Norplant will not prevent HIV transmission to their partners. Use of condom should be strongly recommended with these patients.
References [1] Taneepanichskul S, Intaraprasert S, Phuapradit W, Chaturachinda K. Use of Norplant® implants in asymptomatic HIV-1 infected women. Contraception 1997;55:205–7. [2] Taneepanichskul S. Prevalence of HIV-1 positive mothers in Thailand 1990 –1993. J Obstet Gynaecol 1995;21(Suppl):207. [3] Phemister DA, Laurent S, Harrison FNH. Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance. Am J Obstet Gynecol 1995;172:175–9. [4] Molland JR, Castracave VD, Morehead DB, Castley B, Baldwin DM, Bergquist CA. Immediate postpartum insertion of the Norplant contraceptive device. Fertil Steril 1996;66:43– 8. [5] 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. [6] Taneepanichskul S. First year’s experience with Norplant. Thai J Obstet Gynaecol 1989;1:71–5. [7] Chomprotaweep S, Kochagarn E, Sirisumpan S, Tang-Usaha J, Theppitakjak B, Dusitsin N. Effectiveness of Norplant implants among Thai women in Bangkok. Contraception 1996;53:33– 6. [8] Shoupe D, Mishell DR. Norplant: subdermal implant system for longterm contraception. Am J Obstet Gynecol 1989;160:1286 –92. [9] Gray RH, Campbell OM, Zacur HA, Labbok MH, MacRae SL. Postpartum return of ovarian activity in non-breastfeeding women monitored by urinary assays. J Clin Endocrinol Metab 1987;64:645–50.