- & - MEDICINE
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Introduction
"Corresponding author. Te!.:+27-31-3328315; fax: +27-31- 3328320.
E-mail address:[email protected](J.Smit).
1Supported by the Wellcome Trust.
Women who use injectable contraceptives struggle with the many side effects associated with their use. Yet, despite these side effects, long acting progestogen injectable contraceptives are by far the most popular method of contraception in South Africa, and have been for many years (Smit & Venter, 1993; Chimere-Dan,
Vaginal wetness: an underestimated problem experienced by progestogen injectable contraceptive users in South Africa
Jennifer Smita,b,I*, Lynn McFadyena,b, Kfangelani Zuma", Eleanor Preston-Whyte
"School of Pharmacy and Pharmacology, University of Durban-Westoille, PB X54001, Durban 4001, South Africa
bAfrica Centre for Population Studies and Reproductive Health, South Africa
CBiostatistics Unit, South African Medical Research Council, South Africa
dSchool of Social and Development Studies, University of Natal, South Africa
Abstract
This paper reports on the common experience of vaginal wetness amongst South African users of progestogen-only injectable contraceptives. The observations emerged in the course of a community-based cross-sectional household survey undertaken in a rural district of KwaZulu-Natal in South Africa. The purpose of the survey was to elicit self- reporting on side effects of injectable contraceptive methods. Eight hundred and forty-eight women aged 15-49 were interviewed and 22.1% reported current use of an injectable contraceptive method, either depot medroxyprogesterone acetate (Depo-Provera'P) or norethisterone oenanthate (Nur-Isterate'f), Other modem methods used were oral hormonal contraceptives (4.5%), male condoms (1.3%), the intrauterine device (0.1%), and tuballigation (0.1%).
Vaginal wetness was reported by 18.4% of users and was one of the most common side effects, second only to amenorrhoea (62.5%).Itwas also what 17.5% of the women liked least about using this method. According to almost half the respondents, men regard women who use the injectable contraceptive as "wet", "cold" and/or "tasteless".
These survey findings were supported by participants of 14 focus group interviews held in thesub-district, Since some South African men may prefer dry sex the perception that the injectable contraceptive increases vaginal wetness may be problematic for women who use it. Whilst vaginal wetness can onlybeclassified as a subjective side effect at this stage, further investigations are needed as many South African women opt to use this method. ©2002 Elsevier Science Ltd.
All rights reserved.
Keywords: Progestogen injectable contraceptives; Side effects; Vaginal wetness; South Africa
1996; Beksinska, Rees, Nkonyane, &McIntyre, 1998).
Depot medroxyprogesterone acetate was first introduced in South Africa in the late 1960s (Kaufman, 1997), and in the early 1990s accounted for between 66% and 80%
of contraceptive use (Reproductive Health Task Force, 1994). In rural areas of South Africa injectables have become almost exclusively the method of choice of both user and provider. The two injectable contraceptives available in South Africa are progestogen-only prepara- tions, depot medroxyprogesterone acetate (Depo-Pro- vera~~ and Petogen~\,) and norethisterone oenanthate (Nur-Isterate'f), The combined injectable contraceptive, containing a combination of oestrogen and progestogen 0277-9536/02/$- see front matter©2002 Elsevier Science Ltd. All rights reserved.
Pll:S0277-9536(01)00284-2
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Sampling
In order to test for significant differences in the prevalence of side effects between users of depot medroxyprogesterone acetate and norethisterone oe- nanthate, it was determined that at least 40% of the estimated 2088 households should be visited. The sub- district comprises 13 local areas, known as isigodi.
Commencing from a randomly selected starting point, every second household in eachisigodiwas chosen until 40% of households in each isigodi had been visited.
Among women in the age range 15-49 years, one woman was randomly selected to be interviewed from each household visited. Verbal and written explanations were given (in Zulu and/or English) and no one refused to participate. In all, 848 women were interviewed.
Community groups active in the study area were identified by key informants living in the area. Focus groups interviews (thematic guided discussions) were held with 14 groups identified in this way, to draw out contextual information and to provide insight, depth and perspective to the quantitative cross-sectional data.
It is important to note that both women and men were focus group participants. Six groups were comprised of women only,two of men only, and six of women and The study was undertaken in a rural sub-district in the province of KwaZulu-Natal,South Africa. The popula- tion in this sub-district is estimated at about 20000.
Contraceptive methods are provided by the only health facility in the area, a district hospital which houses a family planning clinic. Prior to commencing the survey, workshops and meetings were held to introduce the study to local leaders,community health workers, and health service providers. Ethical clearance for the study was provided by the Ethics Committee of the University of Durban-WestviUe.
Research site
Both quantitative and qualitative data were collected by means of a cross-sectional, community-based house- hold survey and also from focus group interviews with community groups.
Study design
Subjects and methods J.Smit et al./Social Science&Medicine55(2002) 1511-1522
tyre, 1999;.Brown& Brown,20(0),the perception that the injectable contraceptive increases vaginal wetness may be problematic for South African women who choose to use it. This paper documents reports of, and perceptions about "vaginal wetness" with the injectable contraceptive method.
is not yet available in South Africa and all reference to injectable contraceptives in this paper is confined to progestogen-only products.
Side effects reported by South African women are, on the whole, consistent with those reported elsewhere in the world (Fraser & Weisberg, 1981; Paul, Skegg, &
Williams, 1997), with amenorrhoea and other menstrual disturbances the most common (Beksinska et aI., 1998).
Inaddition,however,women refer frequently to the side effect described or translated from the vernacular as
"vaginal wetness", and no reports of this side effect can be found in the published medical literature. However, four published references have been found which report vaginal discharge as a side effect. One quotes vaginal discharge as a rare symptom of depot medroxyproges- terone acetate (Tyler, 1970). Another reports vaginal discharge as a temporary, short-lived complaint, asso- ciated with the use of depot medroxyprogesterone acetate (zartman, 1967), while the third refers to it as a major side effect (Schwallie, 1976). El-Mahgoub and Karim (1972) report vaginal discharge as a minor side effect of norethisterone oenanthate. Vaginal discharge was also reported as a side effect among injectable contraceptive users at a family planning clinic in KwaZulu-Natal, South Africa (Smit, Goga, & Khan, 1989a; Smit, Mahabeer, & Naranbhai, 1989b). The product brochure of Petogen'P, the locally manufac- tured depot medroxyprogesterone acetate (DMPA) product, lists vaginal discharge under "other side effects" (Intramed, 1993). No such side effect is listed in the product brochures of Nur-Isterate'f and Depo- ProveraP (Schering (Pty.) Ltd., 1992;Pharmacia and Upjohn (Pty.) Ltd., 1993).It is not clear whether the early reports of vaginal discharge, and the vaginal wetness reported in the present study, are analogous.
Whether either of these effects is in reality a consequence of injectable contraceptive use is also unclear, and if so the mechanisms by which they occur are not under- stood.
This paper reports on a study undertaken in a rural community of KwaZulu-Natal. The purpose of the study was to establish the prevalence of long acting injectable hormonal contraceptive use, to elicit self- reporting of associated side effects from injectable users, and to obtain the views of users, non-users and community groups about side effects and problems experienced with injectable contraceptive use.Itwas in respect to the reported side effects that interesting insights surfaced with regard to notions of "wetness"
and perceptions of the link between injectable hormonal contraceptives and vaginal wetness. Sincestudies have shown that men and women in many parts of Central and Southern Africa have a preference for dry sex (Brown, Ayowa, & Brown, 1993a; Brown, Brown, &
Ayowa, 1993b; Civic& Wilson, 1996; Morar& Abdool Karim, 1998;Beksinska, Rees, Kleinschmidt, & McIn- 1512
J.Smit et al.ISocial Science&Medicine55(2002) 1511-1522 1513
men. The composition of the groups is provided in Table 1.
Data collection
An extensive structured interview schedule was administered during home visits. The interview schedule was designed in consultation with health providers, other researchersand interviewers. A thorough reviewof instruments used in studies with similar methodologies, including the 1998 South African Demographic and Health Survey instrument (Department of Health of South Africa, 1999) was also undertaken. Included in the interview schedule were questions on household demographic characteristics; respondents' contraceptive history; user experiencessuch as reasons for selection of the injectable contraceptive, and problems and side effects experienced with this method; knowledge, per- ceptions and opinions about injectable contraceptives;
relevant medical history; and plans about future contra- ceptive use.
After much consultation, the approach of partial translation of key phrases was adopted to ensure that nuances of meanings were not lost in the translation process.An extensive participative workshop was held to identify key phrases for translation. Senior research- ers, the fieldwork manager and fieldworkers were involved in this process. Key phrases identified for translation were printed on the interview schedule in English and Zulu. For instance, the English and Zulu translation of all side effects listed, including increased vaginal wetness and vaginal discharge, appeared one below the other in all cases. The instrument was subjected to face validation (Katzenellenbogen, Joubert,
& AbdoolKarim, 1997) by a group of Pharmacology
Table 1
Composition of focus groups
master's students, and a skilled English/Zulu translator, and was piloted in a neighbouring sub-district.
Since almost all the respondents were expected to be Zulu speakers, interviewers whose first language was Zulu, but who were also fluent in English, were employed. They were all women, recruited from the study site,and were integrally involved in the develop- ment and translation of the interview schedule. Inter- viewers were intensively trained to standardize verbal translation of the complete instrument during interview- ing. All the interviews were conducted in Zulu and the quality of interviewingwas assessedon a daily basis. The interviews took place between September and December 1998 and were largely conducted during the day from Monday to Friday, but where a selectedwoman was not home, a revisit was made in the evening or on Saturday.
A semi-structured aide memoire was designed for the focus group interviews. Six themes, identified from responses to the individual household interviews, were included for discussion. The experience of vaginal wetness was included in the schedule as the fourth theme. The other five themes were: general views and opinions on contraception; general views about inject- able contraceptive use; side effects associated with injectable contraceptives; the use of the injectable contraceptive in the context of high HIV prevalence; and the views of community leaders and elders on the use of contraceptives.The focus groups were held from February to April 1999 and were facilitated by a moderator and a recorder. The interviewers from the survey were trained to facilitate the group discussions and the fieldwork manager, a man, was the moderator for the groups which included men. Discussions were conducted in Zulu, tape recorded, transcribed and translated into English. Some basic demographic
Type of group Sewinggroup Gardening group
Community health workers
Nurses attachedtothe district hospital Traditional healers
Church ministers Taxi drivers Highschool teachers Primary school teachers Parents
Members of a school governing board Grade 12 secondary school girls Grade 11 and 12 secondary school boys Grade 11 and 12 secondary school girls and boys Number of women aged 15-49 (reproductive age) Total
Number of women (age range in years) 6 (34-59)
5 (26-35) 5 (34-47) 8(25-55) 6(35-60) 2 (47-48) 5(23-37) 4 (23-33) 7 (30-60) 3(44-59) 8 (17-24) 4 (17-18) 50 63
Number of men (age rangeinyears)
4 (48-74) 4(37-75) 8 (24-48) 3 (26-28) 3 (26-33) 3(29-57) 8 (18-23) 4 (21-24) 37
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1514 J.Smit et al./ Social Science&Medicine55(2002) 1511-1522 information was collected from each participant of each
focus group at the end of the group discussion.
Analyses
Household interview schedules were coded and double entered using Epi-Info Version 6.43 (Centres for Disease Control and Prevention, Atlanta). The Statistical Analysis System (SAS) Version 6.12 (SAS Institute, Cary Ne) was used for statistical analyses.
Statistical methods employed were univariate statistics.
Differences in quantitative variables were assessed using Student's r-test. Tests of significance for categorical variables were based on the Chi-squared test or Fisher's exact test as appropriate. All p-values were based on a two-sided test. A p-value of less than or equal to 0.05 was considered to be statistically significant.
Focus group interviews were coded and analysed thematically using the pre-identified themes and others that emerged.
Results
Profile of respondents
All respondents (n=848) who participated in the community-based survey were African, Zulu-speaking women. One hundred and eighty-seven women (22.1%) were using the injectable contraceptive method at the time of the survey,and it is this sub-sample which forms the main focus of this paper. The majority of the injectable users (75.3%) had an education level of Grade 8 (8 years of schooling) or above and 61.0% were unemployed.Their mean age was 26.1 years (median 25;
range 17-49). On average,they had 1.9 living children and the maximum number of living children was seven.
The mean age at first pregnancy was reported to be 19.2 years. The youngest age at first pregnancy was 12 and the oldest was 30,with 7.2% first pregnant when they were under 16 years and 60.2% when they were under 20. The average age at first contraceptive use was 22. I years with an age range of 16-42 years.
Table 2 shows that injectable contraceptive users had attained a higher education level than non-injectable users (p= 0.001), more were in a stable relationship (p<O.OOI) and were unemployed(p=0.025), and they were more likely, on average, to have fewer children (p= 0.005). In other respects, the demographic char- acteristics of injectable contraceptive users were similar to those not using this method.
The total number of women participating in the focus group discussions was 63 and there.were 37 male participants (Table 1). The age range of the women was 17-60 years and that of the men was 18-75years.
The age range and gender of the participants of each focus group are provided in Table 1.
Contraceptiveuse
Less than a third (29.7%) of all respondents(n= 848) interviewed at household level reported use of a contra- ceptive method at the time of the survey. Of these, 187 (22.1%) were using an injectable method,either Depo- Provera 'f (DMPA) or Nur-Isterate'f(NET-EN), mak- ing the progestogen injectables by far the most popular contraceptive method. Other modem methods used were:oral hormonal contraceptives (4.5%); male con- doms (1.3%);the intrauterine device (0.1%); and tubal ligation (0.1%). Traditional methods such as withdrawal and thigh sex were reportedly used by 0.9%, and medications not registered for contraceptive use (e.g.
quinine) were being used for contraceptive purposes by 0.7% of respondents. Twelve (24.0%) of the women participating in the focus group discussions,who were of reproductive age (15-49), were using the injectable method.
Injectablecontraceptive use
Forty-six per cent (86) of the women on injectables were using Depo-Provera'fand 54% (101) were using Nur-Isterate'P, The mean length of use was 2.2 years (range 0.1-11),with 41.2% (71) using injectable contra- ceptives for 1 year or less, 23.5% (44) using them for more than a year, but less than 2 years,and 10.2% (19) using them for 5 years or more.
Almost all injectable users (96.3%)chose the method for convenience, as they only had to return to the clinic every two months for NET-EN or every three months for DMPA. Respondents could provide more than one reason, and other reasons given were that: it was perceived to be safe (52.9%);it was effective (47.6%);
it was recommended at the clinic (37.4%); few problems or side effects were experienced (27.3%); it caused amenorrhoea (23.0%); it was recommended by friends or relatives (21.5%); and it was a method that could be hidden from her partner (20.9%). Whilst many side effects were reported, as described in the next section, the majority of the injectable users (86.0%) were satisfied with the method, 6.5% were dissatisfied and 7.5% were unsure how they felt. Those who expressed dissatisfaction, only 12 women, indicated that their dissatisfaction was related to menstrual problems (61.5%) and/or to what they referred to as vaginal wetness (38.5%). A description of vaginal wetness is given in the next section. Almost all (98.4%) indicated that they would continue to use this method.
Participants of the focus group discussions corrobo- rated the above survey findings, being of the opinion that the injectable contraceptive was the most popular
J.Smitet al.]Social Science&Medicine55 (2002)1511-1522 1515
Table 2
Selected demographic characteristics of respondents according to injectable contraceptive user status (injectable users:n= 187;non- usersn=661)
Characteristic Women using injectable
contraceptives
Women not using injectable p-value contraceptives
Age (years)
0.636
Mean (SO) 26.1(5.9) 26.4 (8.1)
Range 17-49 15-48
Education level grade 8 or above(%) 75.3 62.3 0.001
Unemployed(%) 61.0 52.8 0.025
Average household income of SARI000 per month or less(%) 91.6 92.3 0.775
Marital status
Married" 13.4 18.2 0.125
Stable relationship 77.5 57.0 <0.001
Mean number of living children 1.9 2.4 0.005
Maximum number of living children 7 10
Age at first pregnancy (years)
Mean (SO) 19.2 (2.9) 19.2 (3.2) 0.777
Range 12-30 12-40
Age at first contraceptive use (years)
Mean (SO) 22.1(4.9) 21.6 (4.9) 0.081
Range 16-42 14-41
"Bycivil, religious, traditional or customary ceremony.
method in the area. The main reasons given for its popularity were:
• it is convenient,especiallyin that one does not forget to take it, as was thought to be the case with oral contraceptives,
• it is effective,
• it can be hidden from one's partner and others.
It was felt that whilst women experience many problems with the injectable method, they will continue to use it. The following statements illustrate these views:
Itis [used] because one forgets to take the pill. And with the injection, you forget nothing, because you might already have many children or maybe you have a small baby, and you do not want to get another one, so using injection is good although it has got problems.Itstays a long time in the blood.Itis also effective (female primary school teacher).
... there are lot of side effects associated with the use of the injection, but it still comes number one. [This is] because you will find that some of their husbands or partners do not like their women to use methods of contraception, and the injection will only be known by her-whereas there is no hiding place for the pill, the husbands find them within no time (nurse).
They do not want to fall pregnant, they tolerate all kinds of side effects for only one thing which is
prevention of pregnancy (high school girl from group of girls and boys).
Sideeffects
Injectable users interviewed in the household survey were asked to indicate what side effects, if any, they were experiencing with the injectable contraceptive method.
They were first asked to respond to an open-ended question about their experience of side effects, and were subsequently prompted to respond to a list of 22 possible side effects. This list was compiled after a comprehensive review of the published and unpublished literature and after consultation with family planning health care providers. Both English and Zulu versions of each side effect appeared on the interview schedule. In responding to this list, the majority of women (88.4%) reported that they experienced at least one side effect and 7% reported 5 or more side effects. The side effects most commonly reported were amenorrhoea (62.5%), vaginal wetness (18.4%), weight gain (11.2%) and spotting (11.2%) (Table 3). The side effect profile for DMPA and NET-EN users was similar (Table 3). No significant differences were found between DMPA users and NET -EN users in terms of their experience of side effects. Findings from the unprompted version of the question on side effects were consistent with the prompted responses, but frequencies of reporting were lower. All those who spontaneously reported vaginal wetness as a side effect, also reported vaginal wetness when prompted. Again, amenorrhoea and vaginal
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