In/ J G~necol Ohstrt. International
1991. 35: 331-336
Federation
of Gynecology
331 and Obstetrics
Contraception with subdermal levonorgestrel implants as an alternative to surgical contraception at Ilorin, Nigeria 0. Fakeye Department oJ’Obstetrics (Received (Revised
and Gynecology. University
qf Ilorin
Ilvrin.
( Nigeriu)
June 19th. 1989) and accepted June 6th. 1990)
Abstract Acceptability and social characteristics of a cohort of Norplant R, IUD, pill and depo-medroxyprogesterone acetate (DMPA) acceptors who were seen at the University of Ilorin Family Planning Clinic over a IO-week period of the pre-introductory clinical trial of Norplant R, are compared. Findings indicate that NorplantR and DMPA are adopted as an alternative to sterilization by women advanced in reproductive age and of high parity. The pill and IUD are adopted mainly as birth-spacing methods. Women’s education, but not previous use of a contraceptive method, influenced the adoption of Norplant R. The continuation rate at 12 months, a measure of acceptability, was highest, 93.7 per 100 women, for NorplantR and 77.9, 46.7 and 27,7 per 100 women for the IUD, DMPA and the pill, respectively. The need to address the high family size norms in the African subregion is discussed.
Keywords: Subdermal levonorgestrel implants; NorplantR; Oral contraceptives; Intrauterine device; depo-medroxyprogesterone acetate; Surgical sterilization; Acceptability. Introduction There is an increasing need for long-term
1991 International
contraception in the developing world. A recent report [4] estimated that for most of Africa, about 1~~~5% of women with 4 or more children indicate a desire to limit childbearing. In most of these areas sterilization is rarely used and abortion remains illegal. Provision of effective and safe contraceptive methods such as the intrauterine devices (IUDs) with long lasting effect and subdermal implants are some of the new developments to address the demand for long-term contraception. NorplantR, the Population Council’s trademark for the subdermal levonorgestrel implant system, has strong potential for widespread use in the developing countries. In particular, acceptability of Norplant R implant is favored by its safety, high effectiveness and long-term action. Side effects are few, the main being an irregular menstrual pattern which has not been associated with the development of anemia [3]. The accidental pregnancy rate with NorplantR is less than one per 100 women years. Higher failure rates are recorded for oral contraceptives (OCs) and the IUD [l 11, the two other most commonly used methods in this area. Furthermore the six-capsule implant system has been shown to release levonorgestrel in a slow, steady and effective dose of about 30 pg/day for live or more years before requiring replacement [ 11. NorplantR was offered as an additional Clinical und Clinid
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Teaching Hospitul.
Federation
Published and Printed in Ireland
of Gynecology
and Obstetrics
Rescwch
332
Fu/f c.,‘P
contraceptive choice at five pre-introductory clinical trial sites in Nigeria between October 1985 and November 1986. At the University of Ilorin Teaching Hospital, Ilorin, Norplant R was introduced on January 15th, 1986. Over the following lo-week period ending on March 3 lst, 1986, there was a high demand for NorplantR and 50 six-implant systems available for clinical trial were inserted. The overall aim of this report was: (1) to establish the sociodemographic characteristics of Norplant R acceptors and compare them with those of women who adopted other contraceptive methods during the same time period; (2) to compare the sociodemographic characteristics of Nigerian Norplant R acceptors with that reported from other countries where NorplantR is in use; and (3) to evaluate acceptability of NorplantR using the life-table continuation rate at 12 months and compare with life-table continuation rates at 12 months determined for other contraceptive methods, IUDs, OCs and DMPA, that were adopted during the same time period. Materials and methods The study population is the cohort of new acceptors of NorplantR, OCs, IUD and DMPA and those who had surgical sterilization performed at the University of Ilorin Family Planning Clinic between the introductory date and March 3 lst, 1986. All new contraceptors seen during this time period were individually counseled about all available methods of contraception and each made an informed choice of one method. Candidates for NorplantR were instructed that the subdermal implant was undergoing clinical trials and were required to meet the protocol requirements. These included, being between 18 and 40 years old, of proven fertility, nonpregnant and nonlactating. During counseling, potential users of NorplantR are assured they can have the implants removed on request. For all methods, clients with unInt J Gynewl
Ohwt
35
diagnosed genital bleeding, major pelvic pathology and serious medical disorders such as diabetes mellitus, heart disease, sickle cell disease were excluded. Concerning the IUD, none of the acceptors had any contraindications to its use. TCu-200 was the IUD most commonly inserted. Estrogen-progestin OCs containing 50 pg ethinyl estradiol were the only pills available. As a general rule, DMPA acceptors surgical and those requesting sterilization were those who expressed desire to limit childbearing. For this study, all acceptors were between 18 and 40 years old and were given follow-up appointments for 1, 3, 6 and 12 months. From the clinic records, information regarding age, parity, level of education, previous contraceptive use and proportion of users wanting no more children were obtained by contraceptive method, analysed into subgroups and the results obtained for NorplantR acceptors were compared with those of IUD, OC and DMPA acceptors. The statistical significance of differences in mean age and mean parity between acceptors of NorplantR and those of IUD, OC and DMPA was determined by t-tests. Group differences in the educational levels of acceptors were determined by chi-square tests using 2 x 4 contingency tables. Furthermore, selected sociodemographic characteristics such as the mean age and the mean parity obtained for this study population were compared with those reported for acceptors in Finland, Chile, Dominican Republic, Egypt and Thailand. Acceptability which is a measure of continuing use was assessed in this study using the life-table method of Tietze and Lewit [lo] and as modified for long acting injectables by Narkavonnakit et al. [5]. Continuation rates and woman-months of use at 12 months were determined for each contraceptive method and compared. Furthermore, the 12 month continuation rate for NorplantR in this study was compared with rates reported for those countries listed above. The cut-off date for the study was March 30th, 1987, such that all ac-
Suhdermul
ceptors have had a minimum of 12 months of use. Data were updated on June 30th, 1987. Clients lost to follow-up were defined as women who had not been seen in the clinic for a period more than 3 months from the last date of appointment. Results
During the IO-week period, 362 new acceptors were seen, distributed by method choice as: OC 101 (27.90/o),IUD 184 (50.8%), DMPA 22 (6.10/o),NorplantR 50 (13.8%) and surgical sterilization 5 (1.4%). Distributions of acceptors of OC, IUD, DMPA and NorplantR by age, parity, level of education and contraceptive history are given in Table 1. Acceptors of OCs were younger than those of DMPA and NorplantR. There were statistically signilicant differences in mean age between the adopters of NorplantR and OCs (P < 0.05) NorplantR and IUD (P < 0.05), but not bet-
Table I. Characteristics
of January-March
1986 cohort
Iewnorgestrrl
implunts
333
ween Norplant R and DMPA (P > 0.5). Mean parity varied by method; it was lowest (3.7) for OC acceptors and highest (7.6) for DMPA adopters. Using statistical methods, significant differences are recorded in mean parity of NorplantR versus pill (P < 0.05) and DMPA (P < 0.05) but not IUD (P > 0.5) acceptors. Concerning education, the proportions of acceptors that have attained secondary school level of education was highest for Norplant R (68%) and much lower for IUD (40.2X), OC (35.6%) and DMPA (9.1%). Group differences in the educational levels of NorplantR acceptors compared with those of other methods are significant (P < 0.01) when tested by chi-square analysis . It can be concluded that higher educational level favored the adoption of NorplantRimplants. The proportions of acceptors that wanted no more children by contraceptive method choice were low for OC and IUD users, and
of new acceptors:
percentage
distribution
by contraceptive
Characteristic
oc
IUD
DMPA
Norplant
n
101
184
22
50
methods.
R
Age (years)
18-30 3140 Mean SD
60.4 40.6 28.5 5.9
39.0 61.0 30.6 6. I
12.5 87.5 33.7 7.9
26.0 74.0 32.8 4. I
o-7
89. I
79.9
63.6
72.0
7 and over
10.9 3.1 2.2
20. I 4.7 2.3
36.4 7.6 4.6
28.0 5.3 2.0
None Primary Secondary
31.7 32.7 21.8
31.0 28.8 22.8
59. I 31.8 9. I
16.0 16.0 46.0
Post-secondary
13.8
17.4
_..
22.0
7.9
15.2
59. I
54.0
57.4
51.6
68.2
52.0
Parity
Mean SD Level of education
Contraceptive
history
Want no more children Never used
Clinicul
und Clinicul
Reseurch
334
Fakeye
Table 2. In-use countries comparisons of seleted sociodemographic characteristics of NorplantR users. Median age
n
Median parity
Continuation rate (‘K)”
Reference
(years) Chile Dominican Republic
100 100
26.2 23.7
2.2 2.2
91 61
191 191
Finland Egypt Thailand Nigeria
124 250 887 50
29.6 32.5 29.4 32.0
1.4 5.9 2.0 5.3
90 88.4 93.7
191 I71 (61 Present study
‘12 month continuation rate, per 100 acceptors.
greater than 50% for NorplantR and DMPA acceptors, suggesting that the OCs and IUDs were primarily adopted for childspacing, NorplantR and DMPA for limiting childbearing. In Table 2, median age and parity of the study population were compared with those reported for NorplantR acceptors in some selected countries. Social characteristics of Nigerian and Egyptian Norplant R acceptors are comparable, but differ from the other non-African countries where lower family size norms are practised. For all countries reporting, Norplant R’s 12-month continuation rate is remarkably high in the range W--95%, except in the Dominican Republic (61%). Twelve-month events for the cohort of acceptors are reported in Table 3. There were no
accidental pregnancies during use of NorplantR, DMPA and the IUD. The life-table continuation rate at 12 months was highest (93.7%) for NorplantR and lowest (27.7%) for OC. The 12-month continuation rates for the IUD and DMPA were 77.9% and 46.7X, respectively. There were 3 (6%) NorplantR removals, 2 of which were for menstrual problems. Over 50% of OC acceptors were drop-outs and there were 2 failures. These findings suggest low acceptability of the pill in the population under study. The proportion of discontinuers of DMPA (54.2%) at 12 months of use, was high. Discussion The present investigation reveals that in the
Table 3. Twelve-month events and rates by contraceptive method.
oc No. of acceptors Accidental pregnancies Discontinuations for: Expulsion
IUD
101 2
184
-
9
Menstrual problems Medical reasons
-
12
Planning pregnancy
-
3
DMPA
Norplant R
22
50
2
I2 -
8
I
Other personal Total discontinuations Lost to follow-up
8 I3 58
8 37 2
12
3
Continuation rate (‘x) Woman-months of use
27.7 487
77.9 1827
46.7 177
93.7 521.5
Ini J Gynecol Ohsrer 35
I
population studied, women of high parity who are advanced in reproductive age readily adopted contraception using subdermal levonorgestrel implants. That over half of the acceptors indicated some desire to terminate childbearing strongly suggests the use of the implants as an alternative to surgical sterilization. In most parts of Africa, surgical sterilization is not popular and facilities to perform the procedures are often not available. In this regard, a great potential exists in this part of the world for the use of NorplantR, a reversible long-action, hormonal contraceptive method as an alternative to surgical contraception. Reports indicate that NorplantR is being used as an alternative to surgical sterilization in Egypt, while it is mainly used as a birth-spacing method in the Dominican Republic, Thailand and Indonesia [&-81. The study carried out over a 1Zmonth period reveals a comparatively high continuation rate for NorplantR in relation to other contraceptive methods, IUD, DMPA and OCs. The continuation rate is a measure of the degree of satisfaction experienced during the use of a method and these findings affirm a high acceptability for subdermal implants in this population. A number of factors may well have influenced Norplant R’~ high continuation rate in this population. NorplantR requires professional insertion and removal while the pill and DMPA do not require such attention. It has been argued that although NorplantR acceptors are assured of immediate termination of the method on request, the greater difficulty of NorplantR termination may significantly influence its continuation rate. The relatively high education level of the NorplantR acceptors may have also influenced its high continuation rate. The lower continuation rate of OCs and DMPA may have reflected the lack of education in these women. However, there are other known factors that influence the high drop-out rate for OCs in this area. These include noncompliance with daily medication, male opposition and fear of methods [2]. More than half of the women in this study had
never used contraception; in other NorplantR comparative trials, 13-37% had never used contraception [8]. This lack of experience with contraceptives may have affected the continuation rate of OCs and DMPA more than of NorplantR and IUDs. Furthermore, Norplant R and IUD have some characteristics in common; injection mode of insertion and one contact adoption. Both factors are known to influence the adoption and continued use of a contraceptive method. Family size norms in Nigeria, Egypt and most other African countries are high, with an annual population growth rate of 3-3.5%. The positive correlation between high fertility levels and high maternal/infant mortality are well recognized. Besides, negative socioeconomic growth inevitably accompanies unrestrained population growth. An urgent need exists to disseminate accurate information related to the health and socioeconomic values of small family size and to make available an effective long-acting contraceptive method such as Norplant R for the increasing number of women who would like to limit childbearing. Acknowledgment The author would like to acknowledge with gratitude the cooperation of the participants in this study, the staff of the University of Ilorin Teaching Hospital Family Planning Unit, the assistance of Ms. F. Iweanya with statistical analysis and Family Health International, Research Triangle Park, North Carolina for the supply of NorplantR implants and technical assistance on the project. References 1
2
3
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HB.
Diaz
S.
Miranda
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in women
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P: Plasma
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Frank 0: The demand for fertility control in sub-Saharan Africa. Stud Fam Plann 18: 181, 1987. Narkavonnaki T, Bennett T, Balakrishnan TR: Continuation of injectable contraceptives in Thailand. Stud Fam Plann 13: 99, 1982. Satayapan S, Kanchanasinith K, Varakamin S: Perceptions and acceptability of NorplatitR implants in Thailand. Stud Fam Plann 14: 170, 1983. Shaaban MM, Salah M. Zarzour A. Abdullah SA: A prospective study of Norplant R implants and the TCu380Ag IUD in Assiut. Egypt. Stud Fam Plann 14: 163, 1983. Sivin I: International experience with NorplantR and Norplant- contraceptives. Stud Fam Plann 19: 81, 1988. Sivin I, Diaz S, Holma P, Alvarez-Sanchez F. Robertson DN: A four-year clinical study of NorplantR implants. Stud Fam Plann 14: 184, 1983.
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IO Tietze C, Lewit S: Statistical evaluation of contraceptive methods. Clin Obstet Gynecol 17: 121, 1974 I I Trussell J, Kost K: Contraceptive failure in the United States: a critical review of the literature. Stud Fam Plann 18: 237. 1987.
Address for reprints: 0. Fakeye Department of Obstetrics and Gynecology University of Ilorin P.M.B. ISIS Ilorin, Nigeria