|Year : 2017 | Volume
| Issue : 2 | Page : 75-80
Screening for bacterial vaginosis before intrauterine device insertion at a family planning clinic in south-west Nigeria
Opeyemi Rebecca Akinajo1, Folasade A Bello2, Oluwasomidoyin O Bello2, Oladapo O Olayemi2
1 Department of Obstetrics and Gynaecology, Lagos University Teaching Hospital, Idi-Araba, Lagos, Nigeria
2 Department of Obstetrics and Gynaecology, University College Hospital, Ibadan, Oyo State, Nigeria
|Date of Web Publication||24-Jul-2017|
Opeyemi Rebecca Akinajo
P.O.Box 1186, Agege, Lagos
Source of Support: None, Conflict of Interest: None
Aim: This study determined the prevalence of bacterial vaginosis (BV) among clients before insertion of intrauterine device (IUD) and compared the incidence of complications between participants who were positive and negative for BV. Patients and Methods: This was an observational cohort study that was performed between May 2014 and September 2014. A total of 360 women were recruited and followed up for 1 month. High vaginal swabs were obtained from each participant pre-insertion of the IUD and 1 month post-insertion. BV was diagnosed using Nugent's scoring. Data were collected, collated and analysed using frequency distributions and Chi-square test as appropriate. The level of statistical significance was P< 0.05. Results: The prevalence of BV was 33.3%. The complication rate was 23.9% in which 30.5% complication rate was seen among participants positive for BV and 22.5% among participants negative for BV (P = 0.192). This was done with respect to four primary clinical outcomes. The incidence of BV one month after IUD insertion was 11.5%. Conclusion: The prevalence of BV was within the range reported in other populations. The complication rate appeared high; however, the differences in proportion between women positive and negative for BV were not statistically significant.
Keywords: Bacterial vaginosis, complications, intrauterine devices, screening
|How to cite this article:|
Akinajo OR, Bello FA, Bello OO, Olayemi OO. Screening for bacterial vaginosis before intrauterine device insertion at a family planning clinic in south-west Nigeria. Niger Postgrad Med J 2017;24:75-80
|How to cite this URL:|
Akinajo OR, Bello FA, Bello OO, Olayemi OO. Screening for bacterial vaginosis before intrauterine device insertion at a family planning clinic in south-west Nigeria. Niger Postgrad Med J [serial online] 2017 [cited 2020 Apr 6];24:75-80. Available from: http://www.npmj.org/text.asp?2017/24/2/75/211465
| Introduction|| |
One of the common indications for a visit in clinical medicine is vaginal discharge, and this occur frequently in women of reproductive age. The prevalence of bacterial vaginosis (BV) in the USA is 29%, Indonesia is 30%, 25% in Canada, 15% in rural Brazil  and 20%–50% in Zimbabwe. In Nigeria, a study done revealed a rate of 14.2% indicating its significance among women of reproductive age group.
BV is a clinical condition characterised by a change in the vaginal flora causing vaginal discharge, itching and unpleasant odour. The risk factors include age, black race, smoking, douching, intrauterine devices (IUDs) and sexual behaviour. BV may be symptomatic or asymptomatic., According to the recommendation of the United States Centers for Disease Control and Prevention, treatment is recommended for women who develop symptoms  and these symptoms worsened with symptoms associated with IUD insertion. The significance of BV is in its gynaecologic complications including cervicitis, post-operative infections and pelvic inflammatory disease (PID) (endometritis, salpingitis and oophoritis with or without tubo-ovarian abscess) which is caused by the migration of Gardnerella vaginalis into the upper genital tract especially in the presence of IUD. According to the World Health Organization, the risk (PID) is highest within the first 20 days following insertion (1–10/1000 women) and then decreases to baseline (1.4/1000 women). Even though IUD insertion is a risk factor for PID the risk of which is even higher in the presence of BV, few studies are available especially in this part of the world on the importance of screening and possibly treating asymptomatic patients with BV before the procedure, therefore, the need for this study in our environment.
The aim of this study was to evaluate the need for screening for BV before IUD insertion in patients attending the family planning clinic of University College Hospital (UCH), Ibadan, Nigeria. The specific objectives were to assess the prevalence of BV and to compare the incidence of complications between BV-positive and BV-negative women who had IUD inserted with respect to four primary clinical outcomes which are clinical features suggestive of PID (fever, heavy vaginal bleeding, severe pelvic pain and expulsion of the IUD) and to determine the incidence of BV 1 month after IUD insertion.
| Patients and Methods|| |
This was an observational cohort study that was conducted between May 2014 and September 2014 following the approval obtained from the University of Ibadan (UI)/UCH Ethics Committee, Biode Building, Second Floor, Room T10, IMRAT, College of Medicine University of Ibadan, with the assigned number UI/EC/13/0423 which was approved on the 16th April, 2014. The study setting was the Family Planning Clinic of the Department of Obstetrics and Gynaecology, UCH, Ibadan, Nigeria. This referral Centre serves mainly the South-West of Nigeria. The clinic runs every weekday.
All women scheduled for IUD insertion for contraceptive purposes at the Family Planning Clinic, UCH, Ibadan were counselled regarding enrolment in the study. The inclusion criteria included women who were willing and able to provide informed consent and women who were willing and able to comply with the study protocol, availability of mobile phone. The exclusion criteria included: women outside the age range of 18–48 years, previous history of ectopic pregnancy or PID, HIV positive or immunocompromised state, presence of other risk factors for BV (douching, smoking and multiple sexual partners), clinical features of BV, use of antibiotics 4 weeks before IUD insertion and within 1 month of IUD insertion, unavailability of mobile phone.
The participants were educated and counselled on the study and informed written consent was obtained. Each woman had two visits: an initial enrolment visit, during which the IUD was inserted after a swab was taken from the posterior vaginal fornix. This was followed by a follow-up visit 1 month after for a repeat vaginal swab test. At the enrolment visit, the women filled out a questionnaire detailing demographics, sexual history, previous history of sexually transmitted disease or BV, smoking status, number of sexual partners in the past year and past obstetric history. They were counselled and educated about the complication outcomes and the need to avoid the use of over the counter drugs like antibiotics and also to present in the hospital if they have any symptoms so as to assess the severity of the symptoms. At the recruitment of the eligible candidates for the study, a digital thermometer was given to each of the participants after being taught how to use them and each of the participants were followed up 2 weeks (through mobile phone) and 4 weeks post-insertion respectively to rule out the development of the clinical features/symptoms of BV and PID.
At the 1 month post-IUD insertion visit, a follow-up questionnaire was filled detailing the participants' degree of pelvic pain after the IUD insertion (using visual analogue scale which was measured as no pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm) and severe pain (75–100 mm), presence of fever >38°C, heavy vaginal bleeding (excessive menstrual flow in duration and quantity when compared with the normal flow), expulsion of the IUD, or any other symptoms (such as abnormal vaginal discharge) that might have led the patient to seek medical attention. Vaginal swab for a Gram-stain was repeated at this visit. Results obtained were recorded as BV positive or negative. Those who persistently remained positive for BV (even though asymptomatic for BV) were referred to the gynaecological clinic with their culture result for further evaluation and follow-up. Those who developed complications following IUD insertion were also referred to the gynaecological clinic with the result of their culture for evaluation, treatment and follow-up.
The BV score for gram staining was calculated by Nugent's method. The individual scores for each of the three morphotypes of bacteria; Lactobacilli spp., Gardnerella spp., anaerobic Gram-negative rods and Mobiluncus spp., respectively were added together to obtain the total score. The final BV score was described as 1–3 'normal vaginal flora', 4–6 'intermediate', and 7–10 'indicative of BV'.
Using the prevalence of 14.2% from a study done among a population of Nigerian women, it was determined that 324 women would be required for this study at 5% level of significance and 90% power. In order to allow for a 10% loss to follow-up approximately 360 women were recruited.
Data analyses were carried out using Statistical Package for the Social Sciences for Windows Version 18.0.1 (SPSS Inc., 2009. PASW Statistics for Windows, Version 18.0. Chicago, USA). Demographic data and clinical characteristics were summarised as the mean ± standard deviation for continuous variables and as frequency counts (percentages) for categorical variables. The Chi-square test was used to investigate associations between categorical variables.
| Results|| |
A total of 360 women participated in the study, but 330 were successfully followed up till 1 month post-IUD insertion, giving a loss to follow-up rate of about 8.1%. All results were analysed.
The mean age of the respondents was 32.5 ± 6.0 years (range 18–48 years). Out of the respondents, (97.8%) were married and 88.6% were in monogamous family settings. The study population consisted predominantly of artisans/traders (72.2%). About one-third of the study participants had three children (27.2%) [Table 1].
In this study, 120 of the participants were positive for BV at baseline, giving a prevalence of BV to be 33.3%. However, 1 month post-IUD insertion 59 (17.9%) of the respondents tested positive for BV. One month post-IUD insertion, out of 330 participants who came for follow-up, 38 (11.5%) had a shift from normal vaginal flora to BV consistent vaginal flora. Those who remained positive constituted 21 (6.4%) of the study population, while 88 (26.7%) previously BV-positive women became BV-negative.
The majority of the women who initially tested positive for BV were 35 years and above (37.7%) while 22.7% were <30 years and 34.6% were between the ages of 30 and 34 years, (P = 0.747) [Table 2]. Majority of the women who tested positive BV pre-insertion were married with 13.1% in polygamous setting compared to 86.9% in monogamous setting, (P = 0.448). There is a significant association between the prevalence of BV before IUD insertion and occupation (baseline characteristics [P = 0.043] [Table 2], the prevalence of BV post-IUD insertion and the number of children [P = 0.051] with family setting [P = 0.046]).
|Table 2: Association between bacterial vaginosis and baseline characteristics of respondents|
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With respect to the clinical complications of BV 1 month post-IUD insertion, 79 (23.9%) [Table 3] of the respondents had clinical complications with higher rate seen in women who were positive for BV (30.5%) when compared with the rate in BV-negative women (22.5%). However, this was not statistically significant (<0.05). The most common complication was severe pelvic pain with a higher rate in BV-positive women (20.3%) as against (13.7%) seen in BV-negative women; however, this was not statistically significant. Among those with clinical complications, treatment administered included medication mainly analgesics (73.1%) and removal of IUD (6.4%), others (20.5%) did not take any action following complications [Table 3]. Two of the respondents had a history of the passage of foul smelling vaginal discharge and had endocervical swabs for microscopy, culture and sensitivity taken with the result of the culture yielding heavy growth of Klebsiella. They were subsequently treated with antibiotics which the organisms were sensitive to.
|Table 3: Complications occurring in respondents 1 month post-intrauterine devices insertion|
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In comparing the frequency of each clinical outcome in BV-positive and BV-negative women using Chi-square, no significant association was found (P > 0.05) [Table 4]. Also, no significant association was found between complications post- IUD insertion and BV status at pre- IUD insertion (P > 0.05) [Table 5].
|Table 4: Association of complications between bacterial vaginosis positive and negative participants|
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|Table 5: Association of complications and pre-insertion bacterial vaginosis|
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| Discussion|| |
This study shows the prevalence of BV among women who opted for IUD in Ibadan to be 33.3% (pre-IUD insertion) with the incidence (fresh diagnosis) of 11.5% (post-IUD insertion). This prevalence rate is within the range that was found among women of reproductive age group worldwide which was reported to range from 11% to 48%. This study shows the prevalence of BV in a typical population of sexually-active, reproductive-aged women in a stable relationship. In this study, some baseline characteristics (occupation, number of children and family setting) appear to be significant predictors of BV.
Four primary clinical outcomes were used to compare the incidence of complications between BV-positive and BV-negative women, and as seen in this study, the significant clinical complication rate is higher in patients who were BV positive when compared to those who were BV negative but not statistically significant. When compared with another study, the significant clinical complications occurred in patients who were BV negative. In the index study, the association between complications post-IUD insertion with BV status pre-IUD insertion was high among BV-negative women. This is however not statistically significant.
In terms of the secondary outcome, 11.5% of the respondents did experience a change in vaginal flora from BV negative to BV positive therefore making this study to support the hypothesis that the IUD might somehow contribute to a change in the vaginal flora in favour of BV-associated organisms. A longitudinal study comparing the incidence of BV in IUD users to combined oral contraception users found an almost 3 fold increase in BV among IUD users. Possible explanations to this is increased anaerobic bacteria in the vagina due to the presence of a string in the vagina or a foreign body in the uterus., Irregular vaginal bleeding in users of the Copper T IUD have also been implicated. In a study done by Joesoef et al. it was found that BV was associated with the use of IUD. None of these studies tested the vaginal flora for BV before IUD insertion; thus, the causal relationship remains unclear. Neale et al., however, did perform vaginal smears before IUD insertion, at four to 6 weeks and at 6 months after insertion. The prevalence of BV before IUD insertion was lower than the prevalent rate found in our study (7%). The rates of conversion are however similar to that found in our study (11.5% at 4 weeks).
In the index study, it was surprising that the prevalence rate pre-IUD insertion was 33.3% and this rate declined to 17.9% post-IUD insertion, which was an unanticipated finding. All samples taken before IUD insertion were collected during menses (IUDs are passed during menses to rule out pregnancy). Could this have been the reason for the reduced rate of BV post-IUD insertion? Diverse conclusions have been made from studies done in the past as regards the effect of irregular vaginal bleeding and the occurrence of BV.
In a study, although not statistically significant, an association was found between IUD use and BV in women with prolonged irregular vaginal bleeding. It was stated that blood has a neutral pH which raises the pH of the normally acidic vagina. This was contrary to the findings from a study done by Onderdonk et al. which revealed that the total anaerobic populations show modest changes during the menstrual cycle than previously thought which was basically as a result of the increased resistant capability of the anaerobic microflora to environmentally induced changes. These findings, however, were not statistically significant. Studies have also revealed the possibility of spontaneous remission of bacteria vaginosis.
It appears from previous studies that IUD users may have an increased likelihood of having BV, but the real question is whether women with BV at the time of IUD insertion experience more complications after insertion., If this were proven to be true, then existing clinical practice guidelines would have to be reviewed to specifically recommend screening for and treating BV before insertion of an IUD. Currently, this study did not have enough evidence to make this recommendation.
The strength of this study includes the fact that it is a prospective cohort study which allowed for the evaluation of the incidence of BV and the cohort was a socioeconomically diverse type increasing the generalisability of the findings.
The limited study period did not allow for the investigation of the effect of menstrual flow on the colonisation of BV. This limited the ability to assess the unanticipated findings of the reduction in the prevalence rate pre-IUD insertion.
| Conclusion|| |
The prevalence of BV in women who present for IUD insertion in Ibadan has been established to be 33.3% which is within the range of BV studied in other populations. The results of this study support previous work showing no significant clinical complications among women found to have BV at the time of IUD insertion. The current standard of care does not require screening for BV before IUD insertion. However, screening and treatment before IUD insertion must be offered to all users who are symptomatic to prevent complications. Larger samples of women with BV at the time of IUD insertion need to be studied to make substantial observations regarding new information and trends in the clinical outcomes and whether there might be a role for BV screening before IUD insertion.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]