Indian Journal of Medical Sciences Medknow Publications on behalf of Indian Journal of Medical Sciences Trust ISSN: 0019-5359 EISSN: 1998-3654 Vol. 58, Num. 9, 2004, pp. 394-399

Indian Journal of Medical Sciences, Vol. 58, No. 9, September, 2004, pp. 394-399

Original Article

Microbial and cytopathological study of intrauterine contraceptive device users

Agarwal Krishna, Sharma Usha, Acharya Veena

Department of Obstetrics and Gynaecology, SMS Medical College, Jaipur
Correspondence Address:c/o Subhash Agarwal, R K Marbles Pvt. Limited, Kishangarh-Madanganj, Ajmer (Rajasthan) aranag@rediffmail.com

Code Number: ms04068

ABSTRACT

Key Words: Intrauterine device, infection, cytopathology

INTRODUCTION

Reproductive tract infection is one of the major complications caused by prolonged usage of an IUCD.[1],[4],[6],[7],[9],[11] It is recognized that use of IUCD results in quantitative and not qualitative changes in vaginal flora.[3] IUCD has been reported to produce inflammation and changes in cervical cytopathology.[1],[2],[10]

The present study evaluated gynecological problems, spectrum of lower genital tract infections, pattern of cytopathology and risk of cervical malignancy among IUCD users at a tertiary care hospital.

SUBJECTS AND METHODS

This study comprised of study subjects (n=100) using IUCD for variable period and attended family planning clinic or gynecological OPD for routine follow up. The subjects were chosen randomly irrespective of their complaints and socio-demographic profile. The control subjects (n=50) were women who did not have any gynecological complaint and came for IUCD insertion.

The subjects were explained about the study and written informed consent was taken.

The detailed history was obtained. Each subject underwent general physical, systemic and pelvic examination. Hemoglobin was estimated using Sahli′s method. Per speculum examination was carried out to look for thread or displacement of IUCD, condition of vagina and cervix and for discharge. Vaginal discharge was collected from posterior fornix for Gram staining, KOH mount, wet mount and in a transport medium for culture and sensitivity testing. pH of vagina was noted by dipping narrow range pH monitor in the vaginal discharge. An Ayre′s spatula was used to take scrapings from cervix. Bimanual examination was undertaken to rule out pelvic inflammatory disease.

Wet mount smear was examined within 15 minutes of collection for Trichomonas vaginalis. KOH mount was examined for presence of fungal hyphae. A microbiologist examined the Gram stain slides. Bacterial vaginosis was defined as per Nugent criteria.[12] Vaginal discharge was cultured on Mac-conkey (for aerobic growth) and Thayer Martin (for Gonococcus) agar. The organisms were identified by colony morphology and biochemical tests. The isolated organisms were tested for commonly used antibiotics. Cervical smear were stained using Papanicolaou′s staining. A pathologist examined the smears for any cytological abnormality and reported as per Bethesda system.[13]

The clinician, microbiologist and pathologists were unaware of the group of the patient.

The women were counseled a week later using the gathered information. The patients were managed as per the unit protocol. Subsequent follow up was individualized depending upon the diagnosis and patients convenience.

All the clinical and laboratory findings were recorded in a predesigned proforma. The data were entered into Microsoft Excel spreadsheet. The results were expressed as percentages, mean ± standard deviation, median and Interquartile range. The results were analyzed using EPI Info version- 6 and Stata version 7 statistical package. Two tailed t-test, chi square and two-tailed Fisher exact test were applied. The significance level was taken at 5%

RESULTS

Chief complaints of IUCD users included backache, vaginal discharge and menorrhagia [Table - 2].

[Table - 3] summarizes the principal clinical and laboratory findings among the study subjects. The proportion of women suffering from anemia (Hb<11 g %) was higher in IUCD users than controls (29% versus 16%, p 0.12) but this did not reach significance level. However the mean hemoglobin level was lower in IUCD users compared to controls (11.2=17 versus 11.9=1.8, p=0.02). Erosion was significantly higher in IUCD users compared to none in controls (20% versus none, p=0.00). Vaginal discharge smear revealed comparable positivity for Trichomonas vaginalis and fungal hyphae. Gram stain findings of vaginal discharge were not significantly different in two groups. Bacterial vaginosis rate in IUCD users and control was 12% and 8% respectively (p 0.77). Vaginal discharge bacterial culture grew organisms in nearly all the IUCD users and controls. However rates of individual organisms isolated was not significantly different. Cytological findings were predominantly inflammatory with no significant difference in rates in two groups. No case of Actinomycosis was detected in either group. LGSIL and HGSIL were present in 1% and 2% of IUCD users compared to none in controls. The women with HGSIL were ones using the IUCD for 15 and 25 years following forgotten insertion. None of the study subjects had malignant cytological changes.

DISCUSSION

A significant proportion of women had symptoms including menorrhagia in 18% of them. Design of the present study did not permit us comparison with the controls as all the control were asympatomatic by defined study criteria. National Family Health Survey-II reported perceived symptoms in 1371 IUCD users as-no problems(81.5%), too much bleeding(5.8%), headache/bodyache/backache(5.5%), abdominal pain(4.9%), white discharge(2.7%), irregular period(2.4%), weight gain(11.3%), weight loss(1.0%), weakness/tiredness(3.1%), and dizziness (1.0%), cramps(0.5%), spotting(0.4%), breast tenderness(0.25), reduced sexual desire(0.1%).[8] Some of these symptoms may not have cause and effect relationship with IUCD. High incidence of backache may result from bad posture assumed during household work. Nevertheless the perceived symptoms make a regular follow up imperative for counseling and for a better acceptance of the IUCD.

Cervical erosion was present in a significant proportion of study subjects compared to controls. Nayer reported cervical erosion in 13.5% subjects among IUCD users.[9] Thread of IUCD tail being a source of constant irritation may be responsible of cervical erosion. It may provide a conduit for ascending infection from vagina. Though cervical erosion is not considered something with serious implication but it may be responsible for vaginal discharge and other symptoms in the users.

Infection has been one of the main concerns in IUCD use. It is generally recognized that the usage of IUCD results in quantitative and not qualitative alterations in the normal vaginal bacterial flora with increase in anaerobic bacterial organisms following IUCD insertions. The present study showed some increase in trichomonial, bacterial and fungal infection but none of them was significant. Cochrane Review Group noted a low risk of IUCD-associated infection, with or without use of antibiotic prophylaxis, in trials included in the meta-analysis.

The present study reveal only slightly increased incidence of inflammatory smear in study group compared to control group which was statistically not significant. Ashwani et al reported an incidence of inflammatory smear as 57% at 6 wk, 72.6% at 6 months of Cu-T insertion.[10] Fahmy et al also found significant increase in inflammatory smear among IUCD users.

The incidence of dysplasia in present study is comparable to that in general population. Incidences of LGSIL and HGSIL in general population have been reported to be 1.6% and 0.5-0.8% respectively.[14] Two cases of HGSIL in present study were the ones carrying IUCD for prolonged period. It may be correlated to duration of IUCD use but a larger study is needed for confirmation. A large study reported cytology results on 2603 women using copper containing intrauterine devices.[6] The women were followed up to a maximum period of 60 months of study. The rate of dysplastic lesion in initial smears was 2.5%. Grouping the 60 months into 5 time intervals of 1 yr each, the annual rate of dysplasia at follow were 4.2%, 1.6%, 3.8%, 0.9% and 3.0%.[2] The rate of dysplasia in women with initially negative or inflammatory smears did not change significantly during five years.

In conclusion, the present study reiterates the safety of IUCD in general however the users had a lower hemoglobin concentration, higher rates of cervical erosion and significant proportion of them were symptomatic. Thus these women require a regular follow up for counseling, clinical examination and further investigation as needed.

REFERENCES

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