Current practices in family planning: a population based study

Background: To study the knowledge, current practices of family planning methods and acceptance post motivation.Methods: Cross-sectional study conducted at family planning OPD of AIIMS, New Delhi, India. A total of 1516 couples who came for MTP at any gestation couple were enquired about knowledge, currently used contraceptive method and reason for abortion. Couple was counseled and allowed to choose contraceptive method using cafeteria approach. Mean values of continuous data were tested using t-test/ANOVA. Categorial data were compared using chi-square/ Fischers exact test.Results: Mean±SD age of the women was 28.89±5.21 years with 9.98±4.56 weeks POG. Around 81% of women had one or more living children with 62.67% women with at least one abortion previously. Majority used male condoms (42.10%) followed by natural method (21.01%), Cu-T (3.80%), OCPs (1.65%), injectable (0.30%), I-pill (0.24%). Awareness was maximum for male condoms, Cu-T, OCPs, female sterilization (100%) and least for female condoms (20%) and LNG-IUS (8.46%). Contraceptive failure (68.90%), congenital abnormality in the fetus (22.40%), maternal disease (5.90%), rape (1.60%), completed family (0.80%) and not using any method (0.30%) were the reasons of abortion. Majority of abortions were in first trimester (70%). Post-motivation around 69.30% of the couples accepted some form of contraception. Female sterilization (32.50%) method accepted by the couples as compares to temporary methods (36.70%) such as Cu-T, OCPs, Injectables etc.Conclusions: Despite of awareness the family planning programme is unsuccessful largely due to inappropriate attitude. Behavioral modification and communication goes a long way to slove the problem.

Intravenous iron sucrose therapy for moderate to severe anaemia in pregnancy.

Background & objectives: Iron deficiency anaemia (IDA) is the most common nutritional deficiency in pregnancy. Prophylactic oral iron is recommended during pregnancy to meet the increased requirement. In India, women become pregnant with low baseline haemoglobin level resulting in high incidence of moderate to severe anaemia in pregnancy where oral iron therapy cannot meet the requirement. Pregnant women with moderate anaemia are to be treated with parentral iron therapy. This study was undertaken to evaluate the response and effect of intravenous iron sucrose complex (ISC) given to pregnant women with IDA. Methods: A prospective study was conducted (June 2009 to June 2011) in the department of Obstetrics & Gynecology, All India Institute of Medical Sciences, New Delhi. One hundred pregnant women with haemoglobin between 5-9 g% with diagnosed iron deficiency attending antenatal clinic were given intravenous iron sucrose complex in a dose of 200 mg twice weekly schedule after calculating the dose requirement. Results: The mean haemoglobin raised from 7.63 ± 0.61 to 11.20 ± 0.73 g% (P<0.001) after eight wk of therapy. There was significant rise in serum ferritin levels (from 11.2 ± 4.7 to 69 ± 23.1 μg/l) (P<0.001). Reticulocyte count increased significantly after two wk of starting therapy (from 1.5 ± 0.6 to 4.6±0.8%).Other parameters including serum iron levels and red cell indices were also improved significantly. Only one woman was lost to follow up. No major side effects or anaphylactic reactions were noted during study period. Interpretation & conclusions: Parentral iron therapy was effective in increasing haemoglobin, serum ferritin and other haematological parameters in pregnant women with moderate anaemia. Intravenous iron sucrose can be used in hospital settings and tertiary urban hospitals where it can replace intramuscular therapy due to injection related side effects. Further, long-term comparative studies are required to recommend its use at peripheral level.

Low dose mifepristone in medical management of uterine leiomyoma - An experience from a tertiary care hospital from north India.

Background & objectives: Uterine myoma is a common indication for hysterectomy in India. An effective medical treatment option may reduce hysterectomy associated morbidity. This study was undertaken to evaluate efficacy and safety of low dose mifepristone in medical management of myoma and to compare two doses - 10 vs. 25 mg/day. Methods: In this randomized clinical trial, women with symptomatic myoma or myoma>5cm were included. Uterine size >20 wk, fibroids >15 cm were excluded. Pictorial blood loss assessment chart (PBAC) score was used to assess menstrual-blood-loss and visual analog scale (VAS) for other symptoms. Haemogram, liver function test, ultrasound with doppler and endometrial histology was performed. Patients were randomized and were given oral mifepristone as 25 mg/day in group 1 and 10 mg/day in group 2 for 3 months. Patients were followed at 1, 3 and 6 months. Results: Seventy patients in group 1 and 73 in group 2 completed treatment. Mean PBAC score reduced from 253 to 19.8 and from 289.2 to 10.4 at 1 and 3 months in groups 1 and 2, respectively. At 3 months, 67 of 70 (95.7%) patients of group 1 and 66 of 73 (90.4%) of group 2 developed amenorrhoea which reverted after median 34 (range 4-85) days. Mean myoma volume decreased by 35.7 per cent (from 176.8 to 113.7cm3) and 22.5 per cent (from 147.6 to 114.4 cm3) at 3 months in groups 1 and 2, respectively. Side effects seen were leg cramps in 7 of 70 (10%) and 5 of 73 (6.8%) and hot-flushes in 5 of 70 (7.1%) and 5 of 73 (6.8%) in groups 1 and 2, respectively. Repeat endometrial-histopathology did not reveal any complex hyperplasia or atypia in either group. Interpretation & conclusions: Mifepristone (10 and 25 mg) caused symptomatic relief with more than 90 per cent reduction in menstrual blood. Greater myoma size reduction occured with 25 mg dose. Amenorrhoea was developed in 90-95 per cent patients which was reversible. It can be a reasonable choice for management of uterine leiomyoma as it is administered orally, cost-effective and has mild side effects.

Association of Chlamydia trachomatis infection with human papillomavirus (HPV) & cervical intraepithelial neoplasia - A pilot study.

Background & objectives: Human papillomavirus (HPV) is the necessary cause of cervical cancer and Chlamydia trachomatis (CT) is considered a potential cofactor in the development of cervical intraepithelial neoplasia (CIN). The objective of this pilot study was to determine the association of CT infection with HPV, other risk factors for cervical cancer, and CIN in symptomatic women. Methods: A total of 600 consecutively selected women aged 30-74 yr with persistent vaginal discharge, intermenstrual/postcoital bleeding or unhealthy cervix underwent conventional Pap smear, Hybrid Capture 2® (HC2) testing for HPV and CT DNA and colposcopy, with directed biopsy of all lesions. Results: HPV DNA was positive in 108 (18.0%) women, CT DNA in 29 (4.8%) women. HPV/CT co-infection was observed in only four (0.7%) women. Of the 127 (21.2%) women with Pap >ASCUS, 60 (47.2%) were HPV positive and four (3.1%) were CT positive. Of the 41 women with CIN1 lesions, 11 (26.8%) were HPV positive, while two were CT positive. Of the 46 women with CIN2+ on histopathology, 41 (89.1%) were HPV positive, two (4.3%) were CT positive and one was positive for both. The risk of CIN2+ disease was significantly increased (P<0.05) by the following factors: age <18 yr at first coitus, HPV infection and a positive Pap smear. Older age (>35 yr), higher parity, use of oral contraceptives or smoking did not show any significant association with HPV or abnormal histopathology. Parity >5 was the only risk factor positivity associated with CT infection (P<0.05). Interpretation & conclusions: Our findings showed that CT infection was not significantly associated with CIN, and most of its risk factors, including HPV infection, in symptomatic women. Longitudinal studies with carefully selected study sample would be able to answer these questions.

Single visit approach for management of cervical intraepithelial neoplasia by visual inspection & loop electrosurgical excision procedure.

Background & objectives: Developing a feasible and sustainable model of cervical cancer screening in developing countries continues to be a challenge because of lack of facilities and awareness in the population and poor compliance with screening and treatment. This study was aimed to evaluate a single visit approach (SVA) for the management of cervical intraepithelial neoplasia (CIN) using visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) along with loop electrosurgical excision procedure (LEEP) in women attending Gynaecology OPD in a tertiary care hospital in north India. Methods: In this hospital-based study, 450 women receiving opportunistic screening by conventional Pap cytology were also screened by VIA and VILI. VIA/VILI positive cases underwent same-day colposcopy and biopsy of all lesions. If the modified Reid score was >3, the patient underwent LEEP at the same visit. Results: Of the 450 women screened, 86 (19.1%) and 92 (20.5%) women were VIA and VILI positive, respectively. Detection rates of VIA, VILI and cytology findings at ASCUS threshold were 33.3, 35.5 and 24.4 per 1000, women, respectively to detect a lesion >CIN1. For detection of CIN2+ lesion, detection rates of VIA, VILI and cytology were 20, 22.2 and 22.2 per 1000 women, respectively. Sixteen patients with Reid score >3 underwent the See-and-treat protocol. The overtreatment rate was 12.5 per cent and the efficacy of LEEP was 81.3 per cent. There were no major complications. Interpretation & conclusions: The sensitivity of VIA/VILI was comparable to cytology. A single visit approach using visual screening methods at community level by trained paramedical personnel followed by a combination of ablative and excisional therapy can help to decrease the incidence of cervical neoplasia.

Chromosomal abnormalities & oxidative stress in women with premature ovarian failure (POF).

Background & objectives: Premature ovarian failure (POF) is defined as the cessation of ovarian function under the age of 40 yr and is characterized by amenorrhoea, hypoestrogenism and elevated serum gonadotrophin levels. The cause of POF remains undetermined in majority of the cases. This study was aimed to investigate the type and frequency of cytogenetic abnormalities in patients with idiopathic POF and also to study the role of oxidative stress in such cases. Methods: Seventy five women with idiopathic POF were included in this study. Chromosome analysis was done in peripheral blood lymphocytes by conventional GTG banding to identify numerical or structural abnormalities. Cytogenetically normal cases were investigated for reactive oxygen species (ROS) levels in their blood by luminol-chemiluminescence assay. Results: Eighteen chromosomal anomalies were identified in POF patients (24%). Majority of the cases were found to have X-chromosome abnormalities (28%). Overall median ROS range was found to be significantly higher (P<0.01) in POF patients [50480 (120,132966) RLU/min] compared to controls [340 (120,5094) RLU/min]. Among these, 50 per cent of the POF patients had higher ROS levels, 20 per cent had medium elevation and 30 per cent were found to have normal values comparable to controls. Interpretation & conclusions: X-chromosome anomalies were found to be the major contributor of POF. Oxidative stress may be the underlying aetiology in idiopathic premature ovarian failure. Thus the results of this study highlight the role of cytogenetic abnormalities and supraphysiological levels of ROS in causation of idiopathic POF. But the role of oxidative stress needs to be confirmed by other studies on patients from different geographical areas and from different ethnicities.

Utility of pH test & Whiff test in syndromic approach of abnormal vaginal discharge.

Background & objective: In India, National AIDS Control Organization (NACO) introduced syndromic approach to treat patients with abnormal vaginal discharge without a need for laboratory tests. Simple tools like pH test and Whiff test can be done without high expertise, microscope and even speculum. This can improve diagnostic value of syndromic approach of abnormal vaginal discharge. The present study was conducted to evaluate sensitivity and specificity of pH test and Whiff test in diagnosis of abnormal vaginal discharge, considering microscopic diagnosis as gold standard. Methods: This prospective hospital-based study included 564 women with abnormal vaginal discharge. All women were subjected to gynaecological examination, pH test and Whiff test. The findings were compared with microscopic examination. Statistical analysis was done by calculating proportions, percentage, sensitivity and specificity. Results: Vaginitis was diagnosed in 301 (53.37%) women. Bacterial vaginosis (BV) was the commonest type of vaginitis (39.01%). Cervical erosion was the second most common cause (17.91%) and physiological discharge was the third (14.36%). pH > 4.5 and positive Whiff test had sensitivity of 94.09 per cent and specificity 87.5 per cent in diagnosing BV. Similarly pH < 4.5 and positive or negative Whiff test had sensitivity of 83.72 per cent in diagnosing candidiasis. Interpretation &conclusion: pH test and Whiff test can improve diagnostic value of speculum examination where microscope facilities are not available.

Aetiology & risk factors of recurrent vaginitis & its association with various contraceptive methods.

Background & objectives: Women who do not seek treatment for recurrent vaginitis have risk to acquire other sexually transmitted infections. Besides proper antibiotic treatment, male condom acts as a barrier to various infections. Present study was done to assess type of vaginitis, its association with various contraceptive methods and need of male condom in prevention of recurrent vaginitis. Methods: Prospective hospital based cohort study with a total of 400 women with recurrent vaginitis was done. Wet mount and Gram’s staining examination were done to diagnose type of vaginitis. After treatment, proper counselling about good hygiene and use of male condom for 4 months in addition to their contraceptive method was advised. Patients were called after four months or when they developed symptoms of vaginitis. Results: Tubal ligation (38.8%) and non contraceptives (34.0%) were the most common methods used by recurrent vaginitis patients. Bacterial vaginosis (BV, 53.8%) and mixed infection (36.8%) were commonly seen infections. BV was not observed in OC pill users. Overall post-treatment cure was 89.1 per cent. Interpretation & conclusions: Our findings showed that male condom use provided protection against recurrent vaginitis and its use should be promoted with other contraceptive methods in high risk cases. Female condom may be another option.

Comparative evaluation of smear cytology & hybrid capture II for the diagnosis of cervical cancer.

BACKGROUND & OBJECTIVES: There is no ideal screening method for cervical cancer in India with the role of human papilloma virus (HPV) detection yet to be established. This study was undertaken to compare the diagnostic accuracy of HPV testing by hybrid capture II (HC-II) with conventional cervical smear cytology for squamous intraepithelial lesions (SIL). METHODS: This prospective study was conducted at New Delhi during 2003-2004 with patients selected from the gynaecology out patients of the All India Institute of Medical Sciences. Initial screening by a questionnaire and per-speculum examination were used to select high-risk patients. Patients, in whom conventional cytology, HC-II test and colposcopy-directed biopsy were done, formed the basis of this study. RESULTS: Of the 133 patients included in the study, incidence on biopsy of low grade SIL (L-SIL) was 6.77 per cent, high grade SIL (H-SIL) was 8.27 per cent and carcinoma was 3.00 per cent. Sensitivity and specificity of cytology for detection of H-SIL and above lesions was 93.33 and 83.49 per cent while for HC-II it was 93.33 and 90.83 per cent, respectively. HC-II had higher diagnostic accuracy of 91.13 per cent versus 84.68 per cent for cytology. Kappa for HC-II was higher (0.67) than cytology (0.52). Among patients diagnosed to have atypical squamous cells (ASC-US & ASC-H) and L-SIL, HC-II helped to select patients who had significant lesions on biopsy. INTERPRETATION & CONCLUSION: The main utility of HC-II is in the triage of patients with cytology smear diagnosis of ASC-US, ASC-H or L-SIL, for referral to colposcopic examination. HC-II alone has the best diagnostic accuracy but owing to high cost it is unsuitable for general screening in developing countries. Combining HC-II with cytology will refer smaller numbers for colposcopy,improving efficient utilization of available resources.

Evaluation of adjunctive tests for cervical cancer screening in low resource settings.

BACKGROUND: Visual inspection of cervix after application of acetic acid (VIA) is an effective screening tool for cervical cancer in low resource settings, but its low specificity leads to high referral rates. Adjunctive testing may overcome this drawback. AIMS: This pilot study was aimed to assess test performances of VIA, human papillomavirus (HPV) testing and Pap smear, individually and in simulated combinations, to determine the probable best screening option. SETTING AND DESIGN: Gynecology outpatient department (OPD); cross-sectional study. MATERIALS AND METHODS: One hundred women with complaints of irregular vaginal bleeding or discharge, post coital bleeding or unhealthy cervix on examination underwent Pap smear, HPV testing, VIA, colposcopy and biopsy, if indicated, in this screening order. STATISTICAL ANALYSIS: Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for each of the tests with a biopsy result of > or =HSIL taken as the gold standard. Simulated parallel and sequential combinations for VIA/Pap, VIA/HPV and HPV/Pap were calculated and compared with individual test performance. RESULTS: Prevalence of abnormal Pap smears was 5%, VIA positive 51% and HPV positive 16%. Sensitivity and specificity of VIA were 100% and 53.3% respectively. For HPV and Pap tests corresponding figures were 85.7%, 89.7% and 50%, 98.9% respectively. The best simulated combination with a balance of sensitivity and specificity was of VIA followed by HPV testing (sensitivity 85.7%, specificity 95.4%). CONCLUSION: Addition of HPV testing to VIA can increase the specificity of VIA, thereby reducing the referral rates without compromising the sensitivity of the test.

Erythrocyte indices in pregnancy: effect of intermittent iron supplementation.

BACKGROUND: Erythrocyte indices change in pregnancy, mainly due to physiological haemodilution and iron-deficient erythropoiesis. The present study was undertaken to determine the haematological indices during different periods of gestation in women receiving daily iron supplements and compare them with those in women receiving weekly iron supplements. METHODS: Pregnant women < 20 weeks of gestation attending the antenatal clinic at the All India Institute of Medical Sciences were randomized to receive either 100 mg elemental iron daily or 200 mg elemental iron weekly. The haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin and mean corpuscular haemoglobin concentration were estimated at baseline, after 1 month, 3 months and at 34 weeks of gestation. RESULTS: Changes consistent with physiological haemodilution in mid-term pregnancy were noted and the values at 34 weeks of gestation were not significantly different between the two groups. CONCLUSION: The effects of intermittent iron supplementation on the erythrocyte indices in pregnancy are comparable with those observed with daily supplementation.

Rapid prenatal karyotyping using foetal blood obtained by cordocentesis.

BACKGROUND: Prenatal karyotyping using foetal blood samples obtained by cordocentesis is a useful method of detecting abnormal chromosomes in the foetus. METHODS: Cordocentesis was performed in 187 cases for prenatal karyotyping between January 1995 and September 2000. Pregnant women were between 18 and 38 weeks of gestation and their ages ranged from 18 to 40 years. The common indications were ultrasonographic abnormalities (47.6%), history of previous Down syndrome (13.3%), advanced maternal age (11.7%), low maternal serum alpha foetoprotein levels (10.7%), previous child with malformation (10.7%), previous child with trisomy (chromosome 13/18) (2.6%), parent a balanced translocation carrier (1.6%) and high maternal serum alpha foetoprotein levels (1.6%). RESULTS: Analysis of 137 successful cultures showed 8 (5.2%) karyotype abnormalities. The remaining samples could not be reported due to the presence of maternal contamination of the sample (12.3%), inadequate sample (6.4%) or culture failure (9.8%). In those with an abnormal karyotype, obstetric management could be altered appropriately. CONCLUSION: In foetuses at high risk of a chromosomal aberration, a rapidly obtained karyotype is helpful in obstetric management.