High burden of cardiometabolic risk factors in spouses of Indian women with hyperglycaemia in pregnancy.

AIM: To evaluate the burden and association of cardiometabolic risk factors in the spouses of women with and without hyperglycaemia in pregnancy. METHODS: Women with (n = 204) and without (n = 197) hyperglycaemia in pregnancy, along with their spouses, participated in this cross-sectional study. The hyperglycaemia in pregnancy group included women with gestational diabetes and diabetes in pregnancy. A detailed questionnaire was completed for all participants (men and women), documenting relevant personal and medical history, along with biochemical investigations (men). RESULTS: A total of 401 couples were evaluated at the time point during the pregnancy of 24.7 ± 5.2 gestational weeks (mean ± sd). Dysglycaemia (prediabetes or diabetes), overweight/obesity (BMI ≥25 kg/m2 ) and metabolic syndrome were detected in 120 (58.9%), 123 (60.3%) and 98 spouses (48.3%) of women with hyperglycaemia in pregnancy, respectively. In the fully adjusted model, an increased risk of dysglycaemia [odds ratio 1.43 (95% CI 0.95-2.17); P = 0.088], overweight/obesity [odds ratio 1.49 (95% CI 0.98-2.27); P = 0.064] and metabolic syndrome [odds ratio 2.00 (95% CI 1.30-3.07); P = 0.001] was seen in the spouses of women with hyperglycaemia in pregnancy. The prevalence of these metabolic conditions was higher in spouses of women with diabetes in pregnancy compared to spouses of women with gestational diabetes mellitus. CONCLUSIONS: A high burden of cardiometabolic risk factors was observed in the spouses of women with hyperglycaemia in pregnancy. The opportunity provided by pregnancy could be used by the healthcare system not only to improve the health of the woman and her offspring, but also her spouse.

A lifestyle intervention programme for the prevention of Type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus [LIVING study]: protocol for a randomized trial.

AIM: This study aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. METHODS: Women with GDM (diagnosed by oral glucose tolerance test using the International Association of the Diabetes and Pregnancy Study Groups criteria) will be recruited from 16 hospitals in India, Sri Lanka and Bangladesh. Participants will undergo a repeat oral glucose tolerance test at 6 ± 3 months postpartum and those without Type 2 diabetes, a total sample size of 1414, will be randomly allocated to the intervention or usual care. The intervention will consist of four group sessions, 84 SMS or voice messages and review phone calls over the first year. Participants requiring intensification of the intervention will receive two additional individual sessions over the latter half of the first year. Median follow-up will be 2 years. The primary outcome is the proportion of women with a change in glycaemic category, using the American Diabetes Association criteria: (i) normal glucose tolerance to impaired fasting glucose, or impaired glucose tolerance, or Type 2 diabetes; or (ii) impaired fasting glucose or impaired glucose tolerance to Type 2 diabetes. Process evaluation will explore barriers and facilitators of implementation of the intervention in each local context, while trial-based and modelled economic evaluations will assess cost-effectiveness. DISCUSSION: The study will generate important new evidence about a potential strategy to address the long-term sequelae of GDM, a major and growing problem among women in South Asia. (Clinical Trials Registry of India No: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry No: SLCTR/2017/001; and ClinicalTrials.gov Identifier No: NCT03305939).

Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries.

Background: A 9-valent human papillomavirus-6/11/16/18/31/33/45/52/58 (9vHPV) vaccine extends coverage to 5 next most common oncogenic types (31/33/45/52/58) in cervical cancer versus quadrivalent HPV (qHPV) vaccine. We describe efficacy, immunogenicity, and safety in Asian participants (India, Hong Kong, South Korea, Japan, Taiwan, and Thailand) from 2 international studies: a randomized, double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 years; NCT00543543; Study 001); and an immunogenicity study (girls and boys aged 9-15 years; NCT00943722; Study 002). Methods: Participants (N = 2519) were vaccinated at day 1 and months 2 and 6. Gynecological samples (Study 001 only) and serum were collected for HPV DNA and antibody assessments, respectively. Injection-site and systemic adverse events (AEs) were monitored. Data were analyzed by country and vaccination group. Results: 9vHPV vaccine prevented HPV-31/33/45/52/58-related persistent infection with 90.4%-100% efficacy across included countries. At month 7, ≥97.9% of participants seroconverted for each HPV type. Injection-site AEs occurred in 77.7%-83.1% and 81.9%-87.5% of qHPV and 9vHPV vaccine recipients in Study 001, respectively, and 62.4%-85.7% of girls/boys in Study 002; most were mild to moderate. Conclusions: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Asian participants. Data support 9vHPV vaccination programs in Asia. Clinical Trials Registration: NCT00543543; NCT00943722.

Conversion of gestational diabetes mellitus to future Type 2 diabetes mellitus and the predictive value of HbA1c in an Indian cohort.

AIM: To investigate the distribution of and risk factors for dysglycaemia (Type 2 diabetes and prediabetes) in women with previous gestational diabetes mellitus in India. METHODS: All women (n = 989) from two obstetric units in New Delhi and Hyderabad with a history of gestational diabetes were invited to participate, of whom 366 (37%) agreed. Sociodemographic, medical and anthropometric data were collected and 75-g oral glucose tolerance test were carried out. RESULTS: Within 5 years (median 14 months) of the pregnancy in which they were diagnosed with gestational diabetes, 263 (72%) women were dysglycaemic, including 119 (32%) and 144 (40%) with Type 2 diabetes and prediabetes, respectively. A higher BMI [odds ratio 1.16 per 1-kg/m2 greater BMI (95% CI 1.10, 1.28)], presence of acanthosis nigricans [odds ratio 3.10, 95% CI (1.64, 5.87)], postpartum screening interval [odds ratio 1.02 per 1 month greater screening interval 95% CI (1.01, 1.04)] and age [odds ratio 1.10 per 1-year older age 95% CI (1.04, 1.16)] had a higher likelihood of having dysglycaemia. The American Diabetes Association-recommended threshold HbA1c value of ≥ 48 mmol/mol (6.5%) had a sensitivity and specificity of 81.4 and 90.7%, respectively, for determining the presence of Type 2 diabetes postpartum. CONCLUSION: The high post-pregnancy conversion rates of gestational diabetes to diabetes reported in the present study reinforce the need for mandatory postpartum screening and identification of strategies for preventing progression to Type 2 diabetes. Use of the American Diabetes Association-recommended HbA1c threshold for diabetes may lead to significant under-diagnosis.

Comparison of combined hormonal vaginal ring with ultralow-dose combined oral contraceptive pills in the management of heavy menstrual bleeding: A pilot study.

The aim of this study was to compare combined hormonal vaginal ring with ultralow-dose combined oral contraceptive (COC) pills in management of heavy menstrual bleeding (HMB). Fifty patients were randomised into Group I: vaginal ring (n = 25) and group II: COC pills (n = 25). Menstrual blood loss (MBL) was assessed at baseline, 1, 3 and 6 months (while on treatment) and at 9 months (3 months after stopping therapy). There was significant reduction in baseline pictorial blood loss assessment chart (PBAC) score from 440 ± 188 (Mean ± SD) to 178 ± 95, 139 ± 117, 112 ± 84 and 120 ± 108 in group I and from 452 ± 206 to 204 ± 152, 179 ± 125, 176 ± 164 and 202 ± 167 in group II at 1, 3, 6 and 9 months, respectively (p = 0.001). Reduction in MBL was 72% and 62% at 6 months and up to 71% and 55% at 9 months in group I and group II, respectively (p = 0.001). Reduction in MBL with ring was greater at higher baseline PBAC score but lesser in patients with fibroid > 2 cm. Combined vaginal hormonal treatment for HMB is as effective as oral hormonal therapy, with minor and transient side effects and persistence of response after cessation of therapy.

Collaborations in gynecologic oncology education and research in low- and middle- income countries: Current status, barriers and opportunities.

Eighty-five percent of the incidents and deaths from cervical cancer occur in low and middle income countries. In many of these countries, this is the most common cancer in women. The survivals of the women with gynecologic cancers are hampered by the paucity of prevention, screening, treatment facilities and gynecologic oncology providers. Increasing efforts dedicated to improving education and research in these countries have been provided by international organizations. We describe here the existing educational and research programs that are offered by major international organizations, the barriers and opportunities provided by these collaborations and hope to improve the outcomes of cervical cancer through these efforts.

HPV vaccination of immunocompromised hosts.

It is well-established that immunocompromised people are at increased risk of HPV-related disease compared with those who are immunocompetent. Prophylactic HPV sub-unit vaccines are safe and immunogenic in immunocompromised people and it is strongly recommended that vaccination occur according to national guidelines. When delivered to immunocompromised populations, HPV vaccines should be given as a 3-dose regimen.

Evaluation of endometrial changes and p53 expression in tamoxifen treated women: comparison of various methods.

OBJECTIVE: To compare transvaginal sonography (TVS), sonohysterography (SHG), hysteroscopy and endometrial aspiration (EA) and p53 expression in assessing endometrial abnormalities in women on tamoxifen. METHODS: In a cross sectional study of 50 pre- and post-menopausal women receiving tamoxifen for > 2 years, all participants underwent TVS and EA. Those with endometrial thickness > 4 mm on TVS underwent hysteroscopy and SHG. Serum p53 antibody and p53 immunohistochemistry were tested in all women. RESULTS: The sensitivity and specificity when compared with histopathology as the reference standard were as follows: TVS 100% and 33.3%, SHG 85.7% and 50%, hysteroscopy 92.8% and 80.8%, serum p53 50% and 83.3%, and p53 immunohistochemistry 57.1% and 61.1%. Prevalence of endometrial abnormalities was not significantly different in asymptomatic and symptomatic women. CONCLUSION: Tamoxifen-users require routine testing for endometrial evaluation. TVS followed by hysteroscopy and biopsy is an effective option. p53 expression correlates with histological abnormalities.

Pregnancy with chronic kidney disease: outcome in Indian women.

BACKGROUND: Fetal survival and the risk of accelerated renal damage are the two major concerns with pregnancies complicated by chronic kidney disease. Although fetal survival has increased significantly due to improved antenatal and neonatal services, the maternal and neonatal morbidity is still considerable. METHODS: This retrospective analysis of 51 pregnancies was conducted at a tertiary care center in India to estimate the risk of obstetrical complications, perinatal morbidity and mortality, and the effect of pregnancy on renal function in women with different types and severity of renal disease. RESULTS: The type of renal disease and the degree of renal insufficiency did not have a significant effect on the chances of successful pregnancy outcome once the pregnancy had progressed beyond the first trimester. The risk of prematurity was significantly increased when the diastolic blood pressure was >/= 90 mm Hg at conception (OR 8.3, CI 1.6-41.5). All patients with a diastolic blood pressure > 100 mm Hg delivered preterm. Hypertension worsened in 16 (35.5%) women during pregnancy, of which 13 had to be terminated preterm because of uncontrolled blood pressure. Serum creatinine deteriorated during pregnancy in 32.5%, the percentage increase showing a significant inverse correlation to the baseline creatinine clearance. CONCLUSIONS: Hypertension at conception was a significant independent factor influencing the gestational age at delivery. The baseline renal function did not correlate with the risk of acceleration of hypertension during pregnancy. However, the deterioration of renal function during pregnancy had a significant inverse correlation to basal creatinine clearance.

Effect of antiprogestin RU 486 on the proliferation and metabolic activity of stromal cells separated from human endometrium.

The effects of RU 486 on the proliferation and metabolic activity of human endometrial stromal cells in culture were studied. RU 486 at 10(-7) M/well significantly stimulated (P < 0.001) the growth as well as metabolic activity in the culture system. Interestingly, RU 486 at 10(-6) M/well did not stimulate metabolic activity in the culture. Progesterone, in combination with RU 486 at 10(-7) M/well, caused a significant increase in proliferation (assessed by thymidine incorporation) (P < 0.001) over control and P4 alone, but not significantly different from RU 486 at 10(-7) M/well alone. The same pattern was observed for metabolic functions (assessed by uridine incorporation) when RU 486 at 10(-7) M/well, along with P4, was added to the culture. Interestingly, RU 486 at 10(-6) M/well with P4 had no effect on RNA synthesis in the culture. The relevance of these findings is discussed.

Pelvic examination, transvaginal ultrasound and transvaginal color Doppler sonography as predictors of ovarian cancer.

OBJECTIVE: To assess and compare the efficacy of pelvic examination, transvaginal ultrasound and transvaginal color Doppler imaging in differentiating benign and malignant ovarian tumors. METHODS: 34 patients with ovarian tumors scheduled for laparotomy underwent pelvic examination and a diagnosis of benign or malignant tumor was made. Transvaginal ultrasound was carried out to study the ovarian morphology followed by color Doppler imaging. A score of > or = 9 on Sassone scoring system or a pulsatility index < 1 was taken as suspicious for malignancy. RESULTS: Of all the three indicators (pelvic examination, transvaginal sonography and Doppler) transvaginal sonography had the highest sensitivity (100%) and Doppler had maximum specificity (96.29%) for predicting malignancy. However, statistical analysis did not show any difference in the predicting ability of these three modalities. CONCLUSION: Pelvic examination, transvaginal sonography and Doppler all had similar ability to predict malignancy in an adnexal mass.

Successful ultrasound-guided intrauterine blood transfusion in severe non-immune hydrops fetalis.

Non-immune hydrops fetalis has varied etiology, high mortality and few known successful treatment modalities. A rare case of non-immune fetal hydrops with severe anemia diagnosed prenatally and treated successfully by repeated ultrasound-guided intrauterine blood transfusions is presented.

Twin pregnancy following gonadotrophin therapy in a patient with Sheehan's syndrome.

A case of Sheehan's syndrome presented with secondary amenorrhea and was put on L-thyroxine, prednisolone and cyclical estrogen and progestin. Ovulation induction with gonadotrophins and intrauterine insemination with husband's semen resulted in a twin pregnancy. Antepartum course was complicated by bronchial asthma, gestational diabetes and pregnancy-induced hypertension. Cesarian section was done at 34 weeks gestation for preterm rupture of membranes and breech presentation. Both babies and their mother were doing well at 6 months of follow-up.

Can amniotic fluid distribution predict fetal outcome?

OBJECTIVE: This study was designed to determine whether the distribution pattern of amniotic fluid (AF) within the uterine cavity is related to perinatal outcome. STUDY DESIGN: One-hundred women in labor with intact membranes underwent a real time ultrasound examination to measure the AF index. Patients were divided into two groups based on liquor distribution. Those with > 50% liquor distributed in upper quadrants formed the 'upper greater' group whereas the rest of the patients constituted the 'lower greater' group. Pregnancy outcome was assessed with respect to incidence of fetal heart rate (FHR) abnormalities, operative delivery, meconium stained liquor, Apgar score < 7 at 1 and 5 min and neonatal intensive care unit admissions. RESULTS: A total of 100 patients were evaluated. The 'upper greater' group had a higher incidence of cesarean for non-reassuring FHR (40.74% vs. 9.6%, P < 0.001), persistent variable deceleration (14.8% vs. 0%, P < 0.001) and bradycardia (25.9% vs. 4.1%, P < 0.001). There was no statistically significant difference in the Apgar score < 7 at 1 min and neonatal intensive care unit admissions in the two groups. CONCLUSIONS: Distribution of less liquor in the lower quadrants of the uterus predisposed to abnormalities in FHR and hence, cesarean section. The distribution pattern did not have a predictive value for the perinatal outcome.

Cardiac disease in pregnancy.

OBJECTIVES: To evaluate the maternal and fetal outcome of pregnancies complicated by cardiac disease in a developing country. METHODS: A retrospective analysis was carried out of 207 pregnancies in women with cardiac disease who delivered at >or=28 weeks of gestation from June 1994 through December 2000 at a tertiary care center. RESULTS: Rheumatic heart disease (n=183, 88%) with isolated mitral stenosis (n=71) was the predominant cardiac problem. Septal defects were the most common form of congenital heart disease (n=24). In 28 (13.52%) women, the diagnosis of cardiac disease was made during pregnancy. Cardiac complications were noted in 62 (29.95%) and fetal complications in 42 (20.28%) pregnancies. Patients in NYHA class I/II (n=175, 84.54%) had fewer maternal complications and their babies had a higher birth weight than those in NYHA class III/IV (n=32, 15.45%). Cardiac intervention was performed prior to pregnancy in 111 (60.65%) patients with rheumatic heart disease: PTMC/CMV in 73 and valve replacement (VR) in 38. Maternal and fetal outcome was better in patients with prosthetic valves (n=38) and the majority (97.4%) of them remained in NYHA class I/II. Cardiac intervention was safely carried out during pregnancy in 10 women (PTMC in 7, CMV in l, and VR in 2). One of them developed congestive cardiac failure during labor. None of the newborns of the 41 women who had received anticoagulants had any congenital malformation. CONCLUSIONS: Rheumatic heart disease was the predominant type. Patients in NYHA class I/II had a better maternal and fetal outcome than those in NYHA class III/IV. Surgical correction of the cardiac lesion prior to pregnancy was associated with better pregnancy outcome. Pregnant women with prosthetic valves tolerated pregnancy well.

Correlation of computed tomography with second-look laparotomy in ovarian carcinoma.

BACKGROUND: Cancer of the ovary is the second commonest gynaecological malignancy after cancer of the cervix. Surgery followed by cisplatin-based chemotherapy is the standard treatment approach. In patients with persistent disease, second-look laparotomy offers an opportunity to debulk the tumour. This is usually followed by an alternative method of chemotherapy. We compared the findings at surgery (second-look laparotomy) with the preoperative computed axial tomography scan assessments. METHODS: Thirty-seven patients with epithelial ovarian carcinoma were assessed with computed axial tomography scans of the abdomen and pelvis prior to undergoing a second-look laparotomy. RESULTS: Tumour was correctly identified on computed axial tomography scan in 11 patients who had macroscopic evidence of cancer at laparotomy. In 6 patients, both computed axial tomography scan and surgery showed no disease recurrence. In the remaining 20 patients, there was a mismatch between the computed axial tomography scan and the surgical findings. In 16 of the 20 (80%) patients, computed axial tomography scans were negative but tumour was present. When the tumour was less than 1.5 cm in diameter it was missed in 8, and when equal to or greater than 1.5 cm, it was missed in 5 patients. These small tumour deposits were located in the retroperitoneal area, under the dome of the diaphragm, omentum or peritoneum, liver surface, and in the pouch of Douglas. In one case each, infiltration of the urinary bladder, sigmoid colon and rectum was also not detected. In 4 patients, computed axial tomography scans showed tumour when none was present. CONCLUSION: Computed axial tomography scan cannot detect small nodules often present in ovarian cancer, and thus even if a computed axial tomography scan is normal it should not exclude a second-look laparotomy.

Visual inspection for cervical cancer screening: evaluation by doctor versus paramedical worker.

BACKGROUND: In the absence of an effective cervical cancer screening programme, efforts are being made to explore the feasibility of using the existing infrastructure to develop effective low-cost screening methods. AIMS: To evaluate and compare test performance of visual inspection of the cervix by a doctor and a paramedical worker. SETTING AND DESIGN: Gynaecology outpatient department (OPD), All India Institute of Medical Sciences, New Delhi; cross-sectional study. MATERIAL AND METHODS: One hundred women with complaints of vaginal discharge, irregular bleeding, post coital bleeding or unhealthy cervix underwent visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) by a doctor and nurse, followed by colposcopy and biopsy. STATISTICAL ANALYSIS USED: Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for each test and compared. Concordance was determined by kappa statistics. RESULTS: VIA by nurse had a higher sensitivity (100% versus 87.5%), but lower specificity (53% versus 63%) when compared with the doctor, but it was not statistically significant. There was moderate agreement between their VIA findings (kappa=0.56). VILI findings were comparable to that of the VIA, both by the doctor and nurse. There was almost perfect agreement (kappa=0.89) between VILI by the doctor and nurse. CONCLUSION: Visual inspection can be performed reliably by trained paramedical workers and doctors and is an effective screening option in low resource settings.

Correlation of radiological and pathological assessment of tumour volume with lymph node involvement in cancer cervix.

The present study was carried out in 18 patients with carcinoma cervix stage IB through early IIB-Preoperative computerised tomography (C.T.) was done within seven days before surgery. Volume of tumour was determined from the C. T. films. Radical hysterectomy Type-III was performed in all 18 patients and specimens of cervix, parametrium and lymph nodes subjected to histopathological examination. Each specimen of cervix was cut into 4 to 12 equal sections depending on the size of the tumour mass. Cervical tumour volume was measured. Correlation of radiological with pathological tumour volume and of tumour volume with lymph node involvement was done. C. T. Scan was able to detect tumour mass accurately only four patients (Sensitivity 40%, Specificity 28.5%). In the Indian setting the conventional surgical approach appears to be the more appropriate.

Tamoxifen increases the proliferation of human endometrial stromal cells in in vitro. A model for evaluation of endometrial hyperplasia.

Tamoxifen given for breast cancer therapy, has a complex and an unclear action on the endometrium. A large number of literatures has attributed the proliferous changes in the endometrium caused by tamoxifen (Tam). No report has appeared on the endometrial cellular changes induced by Tam. The present study shows a significant (P < 0.001) increase in the proliferative activity due to Tam in endometrial stromal cells over control and estradiol (E2). This in vitro model is useful for the study of the hyperplasic effect of Tam at the cellular level.