Phase II clinical trial with Praneem polyherbal tablets for assessment of their efficacy in symptomatic women with abnormal vaginal discharge (an ICMR task force study).

Abnormal vaginal discharge syndrome (AVDS) is a commonly observed gynaecological complaint for which women seek medical attention. The present study was conducted in six Indian Council of Medical Research centres with Praneem polyherbal tablets (PPT), to determine their efficacy in the treatment of symptomatic women with AVDS. Data are given on 141 subjects investigated. In total, 137 women (97%) reported complete (n=62, 44%) and partial (n=75, 53%) relief from symptoms after use of PPT for seven consecutive days. On speculum examination, 71 (74%) women were confirmed to be cured of AVDS. Microbiological tests could only be conducted microscopically for Trichomonas vaginalis, Candida albicans and bacterial vaginosis. It was observed that all women with T. vaginalis had this infection cured by PPT, and the cure rate was 77% for C. albicans and 68% for bacterial vaginosis. Seventy-eight women (55%) reported a transient burning sensation, mostly on the first 2 d of intake of PPT; however, they continued to use the tablets for the prescribed 7 d. This study lays the basis for an extended Phase II/III clinical trial, preferably randomized and comparing a larger number of women to confirm the safety and efficacy of PPT.

Vitamin B12 and folate concentrations during pregnancy and insulin resistance in the offspring: the Pune Maternal Nutrition Study.

AIMS/HYPOTHESIS: Raised maternal plasma total homocysteine (tHcy) concentrations predict small size at birth, which is a risk factor for type 2 diabetes mellitus. We studied the association between maternal vitamin B12, folate and tHcy status during pregnancy, and offspring adiposity and insulin resistance at 6 years. METHODS: In the Pune Maternal Nutrition Study we studied 700 consecutive eligible pregnant women in six villages. We measured maternal nutritional intake and circulating concentrations of folate, vitamin B12, tHcy and methylmalonic acid (MMA) at 18 and 28 weeks of gestation. These were correlated with offspring anthropometry, body composition (dual-energy X-ray absorptiometry scan) and insulin resistance (homeostatic model assessment of insulin resistance [HOMA-R]) at 6 years. RESULTS: Two-thirds of mothers had low vitamin B12 (<150 pmol/l), 90% had high MMA (>0.26 micromol/l) and 30% had raised tHcy concentrations (>10 micromol/l); only one had a low erythrocyte folate concentration. Although short and thin (BMI), the 6-year-old children were relatively adipose compared with the UK standards (skinfold thicknesses). Higher maternal erythrocyte folate concentrations at 28 weeks predicted higher offspring adiposity and higher HOMA-R (both p < 0.01). Low maternal vitamin B12 (18 weeks; p = 0.03) predicted higher HOMA-R in the children. The offspring of mothers with a combination of high folate and low vitamin B12 concentrations were the most insulin resistant. CONCLUSIONS/INTERPRETATION: Low maternal vitamin B12 and high folate status may contribute to the epidemic of adiposity and type 2 diabetes in India.

Characteristics of gestational diabetic mothers and their babies in an Indian diabetes clinic.

AIMS AND OBJECTIVES: To compare clinical and metabolic features of mothers with gestational diabetes (GDM) and their offspring with those in non-diabetic pregnancies at the King Edward Memorial Hospital, Pune, India. MATERIALS AND METHODS: Antenatal information was obtained from hospital records. GDM was diagnosed by 75 g OGTT (Oral Glucose Tolerance Test) in clinically high-risk women. Anthropometric measurements of mother and the babies were recorded within 24h of delivery and a maternal blood sample collected for hematological and biochemical measurements. RESULTS: Between the period Jan 1998 to December 2003,265 women with gestational diabetes were treated in our Unit. Forty nine percent had first-degree relatives with diabetes. Compared to non-diabetic mothers (n=215) GDM mothers were older (29.0 vs. 26.0y, p<0.001), more obese (body mass index- BMI 26.0 vs. 22.0 kg/m2, p<0.001), centrally obese (Waist hip ratio-WHR 0.89 vs 0.86, p<0.001), adipose (sum of 4 skinfolds 98.4 vs. 61.4 mm, p<0.001) and had higher blood pressure (127/80 vs. 122/70 mmHg, p<0.001). GDM mothers had higher concentrations of plasma triglycerides (195.0 vs. 153.0 mg/dl, p<0.01); blood hemoglobin (11.7 vs 10.9 g/dl, p<0.001) and higher platelet count but lower concentration of HDL cholesterol and albumin. Sixty percent GDM mothers and 34% of non-diabetic mothers were delivered by caesarean-section, 23% of GDM mothers delivered pre term (<37 wk). Despite the smaller gestation, babies of GDM mothers were heavier (BW 2950.0 vs. 2824.0g, p<0.001, adjusted for gender), longer (48.9 vs. 48.0 cm, p<0.01) and more adipose (sum of 2 skinfolds 10.5 vs. 8.5 mm). Only 5% of babies born to GDM mothers weighed > 4000 g but 30% were >90th centile of birth weight of babies born to non-diabetic mothers. Babies of GDM mothers suffered higher neonatal morbidity. CONCLUSIONS: GDM mothers in urban India are more obese and more adipose than non-diabetic mothers, frequently have a family history of diabetes and show metabolic features of insulin resistance syndrome, suggesting high cardiovascular risk. Neonates of GDM mothers are heavier, longer and more adipose than those born to non-diabetic mothers, and suffer higher neonatal morbidity.

Neonatal anthropometry: the thin-fat Indian baby. The Pune Maternal Nutrition Study.

OBJECTIVE: To examine body size and fat measurements of babies born in rural India and compare them with white Caucasian babies born in an industrialised country. DESIGN: Community-based observational study in rural India, and comparison with data from an earlier study in the UK, measured using similar methods. SUBJECTS: A total of 631 term babies born in six rural villages, near the city of Pune, Maharashtra, India, and 338 term babies born in the Princess Anne Hospital, Southampton, UK. MEASUREMENTS: Maternal weight and height, and neonatal weight, length, head, mid-upper-arm and abdominal circumferences, subscapular and triceps skinfold thicknesses, and placental weight. RESULTS: The Indian mothers were younger, lighter, shorter and had a lower mean body mass index (BMI) (mean age, weight, height and BMI: 21.4 y, 44.6 kg, 1.52 m, and 18.2 kg/m(2)) than Southampton mothers (26.8 y, 63.6 kg, 1.63 m and 23.4 kg/m(2)). They gave birth to lighter babies (mean birthweight: 2.7 kg compared with 3.5 kg). Compared to Southampton babies, the Indian babies were small in all body measurements, the smallest being abdominal circumference (s.d. score: -2.38; 95% CI: -2.48 to -2.29) and mid-arm circumference (s.d. score: -1.82; 95% CI: -1.89 to -1.75), while the most preserved measurement was the subscapular skinfold thickness (s.d. score: -0.53; 95% CI: -0.61 to -0.46). Skinfolds were relatively preserved in the lightest babies (below the 10th percentile of birthweight) in both populations. CONCLUSIONS: Small Indian babies have small abdominal viscera and low muscle mass, but preserve body fat during their intrauterine development. This body composition may persist postnatally and predispose to an insulin-resistant state.

Low midpregnancy placental volume in rural Indian women: A cause for low birth weight?

OBJECTIVE: We sought to study midpregnancy placental volume in rural Indian women, its maternal determinants, and its relationship to neonatal size. STUDY DESIGN: We performed a prospective community-based study of maternal nutrition and fetal growth in 6 villages near the city of Pune. Measurements included midpregnancy placental volume determined by means of ultrasonography at 15 to 18 weeks' gestation, maternal anthropometric measurements before and during pregnancy, and maternal blood pressure and biochemical parameters during pregnancy. Neonatal size and placental weight were measured at birth. RESULTS: The mothers were short and underweight (mean height, 1.52 m; weight, 42 kg; body mass index, 18 kg/m(2)) and produced small babies (mean birth weight, 2648 g). Midpregnancy placental volume (median, 144 mL) was related to the mother's prepregnancy weight (r = 0.15; P <.001) but not to weight gain during pregnancy, blood pressure, or circulating hemoglobin, ferritin, red blood cell folate, or glucose concentrations. Midpregnancy placental volume was related to placental weight at birth (r = 0.29; P <.001) and birth weight (r = 0.25; P <.001) independent of maternal size. CONCLUSION: In Indian mothers midpregnancy placental volume is significantly associated with prepregnant maternal weight and is an independent predictor of birth weight. Our findings may provide clues to the high prevalence of low-birth-weight infants in India.

Too far, too little, too late: a community-based case-control study of maternal mortality in rural west Maharashtra, India.

A total of 121 maternal deaths, identified through multiple-source surveillance in 400 villages in Maharashtra, were prospectively enrolled during 1993-95 in a population-based case-control study, which compared deaths with the survivors of similar pregnancy complications. The cases took significantly longer to seek care and to make the first health contact after the decision to seek care was taken. They also travelled significantly greater distances through a greater number of health facilities before appropriate treatment was started. Multivariate analysis showed the negative effect of excessive referrals and the protective effect of the following: residing in and not away from the village; presence of a resident nurse in the village; having an educated husband and a trained attendant at delivery; and being at the woman's parents' home at the time of illness. Other significant findings showed that deaths due to domestic violence were the second-largest cause of deaths in pregnancy, that more than two-thirds of maternal deaths were underreported in official records, and that liveborn infants of maternal deaths had a markedly higher risk of dying in the first year of life. This study points to the need for information-education-communication (IEC) efforts to increase family (especially male) preparedness for emergencies, decentralized obstetric management with effective triage, and a restructuring of the referral system.

PIP: Maternal deaths account for 13% of all deaths among reproductive-aged women in India. 121 maternal deaths, identified through multiple-source surveillance in 400 villages in Maharashtra, were prospectively enrolled during 1993-95 in a population-based case-control study comparing deaths with the survivors of similar pregnancy complications. Mothers who died took significantly longer to seek care and to make the first health contact after deciding to seek care. They also travelled significantly farther through more health facilities before appropriate treatment was started. Multivariate analysis showed the negative effect of excessive referrals and the protective effect of living in rather than away from villages, having a resident nurse in the village, having an educated husband and a trained attendant at delivery, and being at the woman's parents' home at the time of illness. Domestic violence was the second largest cause of deaths in pregnancy, more than two-thirds of maternal deaths were underreported in official records, and liveborn infants of maternal deaths had a significantly higher risk of dying during the first year of life. Information-education-communication efforts to increase family preparedness for emergencies, decentralized obstetric management with effective triage, and a restructuring of the referral system are needed.

Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: a comparative trial of mifepristone-misoprostol versus surgical abortion.

OBJECTIVE: We investigated safety, efficacy, and acceptability of an oral regimen of medical abortion compared with surgical abortion in three developing countries. STUDY DESIGN: Women (n = 1373) with amenorrhea < or = 56 days chose either surgical abortion (as provided routinely) or 600 mg of mifepristone followed after 48 hours by 400 micrograms of misoprostol. This is the appropriate design for studying safety, efficacy, and acceptability among women selecting medical abortion over available surgical services. RESULTS: The medical regimen had more side effects, particularly bleeding, than did surgical abortion but very few serious side effects. Failure rates for medical abortion, although low, exceeded those for surgical abortion: 8.6% versus 0.4% (China), 16.0% versus 4.0% (Cuba), and 5.2% versus 0% (India). Nearly half of failures among medical clients were not true drug failures, however, but surgical interventions not medically necessary (acceptability failures or misdiagnoses). Women were satisfied with either method, but more preferred medical abortion. CONCLUSION: Medical abortion can be safe, efficacious, and acceptable in developing countries.

PIP: A multi-center comparative study of medical compared to surgical abortion confirmed that medical abortion can be safe, effective, and acceptable in developing countries. A total of 1373 women from medical centers in China, Cuba, and India with pregnancies of 56 days' gestation or less were given the choice of surgical abortion or 600 mg of mifepristone followed after 48 hours by 400 mcg of misoprostol. Since the majority selected medical abortion, researchers in China and Cuba assigned some of these women to the surgical group to equalize the size of the two groups. The surgical abortion failure rates in China, Cuba, and India were 0.4%, 4%, and 0%, respectively, while the failure rates for medical abortion were 8.6%, 16.0%, and 5.2%, respectively. In all sites, both medical failures (an adverse effect resulting in a medically indicated surgical intervention) and acceptability failures (failure to complete the entire regimen) contributed substantially to the gross failure rates for medical abortion. Medical abortion failure rates increased with gestational age. Although cramping, nausea, and vomiting were more frequent among women in the medical abortion group and bleeding was heavier, general assessments of well-being reported at exit interviews did not differ between the two treatment groups at any site. Regardless of abortion method, the majority of women were either satisfied or highly satisfied with the procedure. In all countries, a higher number of medical than surgical abortion patients indicated they would opt again for the same procedure. Neither the bleeding pattern nor the higher failure rate associated with medical abortion justify withholding this option from women in developing countries.

Foetal growth parameters--clinical versus ultrasonographic.

The study was conducted in 2831 pregnant women with no diagnosed complication at the time of registration to obtain normal foetal growth pattern for clinical and ultrasonographic parameters. Normal values for maternal weight, fundal height and abdominal girth for clinical and biparietal diameter, abdominal circumferences and femoral length for ultrasonographic parameters are presented. Clinical and ultrasonographic parameters were compared for their efficacy in prediction of low birth weight. Neither clinical nor ultrasonographic parameters were found to be satisfactory in identifying the foetus at risk of low birth weight. It has been found that clinical parameters for routine monitoring are as effective as ultrasonographic parameters and have the added advantage of being easily replicable at the peripheral level of health care.

Single high dose of intravenous phenytoin sodium for the treatment of eclampsia.

Phenytoin sodium was administered intravenously as a single 900 mg dose in 33 consecutive women with eclampsia immediately on admission. No untoward effects were observed either in the mother or subsequently in the neonate. Since the patient's level of consciousness is unaltered by the drug, it could be monitored serially as part of neurological assessment. The risks of pulmonary aspiration, respiratory depression and airway obstruction arising from deep sedation which occurs with standard regimens, were averted. Control of convulsions was adequate without the need for any complicated drug related patient monitoring.

Randomized clinical trial with intrauterine devices (levonorgestrel intrauterine device (LNG), CuT 380Ag, CuT 220C and CuT 200B). A 36-month study. Indian Council of Medical Research Task Force on IUD.

A total of 1905 subjects were randomly allocated to four types of intrauterine devices (IUDs) and were observed for 45,683 woman-months of use. While no method failure was observed with levonorgestrel (LNG) IUD, 11 women became pregnant with other devices; 4 with Copper T 380Ag, 1 with Copper T 220C, and 6 while using Copper T 200B, indicating method failure rates of 1.0, 0.3 and 1.6, respectively, at 36 months of use. These rates were within acceptable range. Continuation rates were significantly lower with LNG IUD (74.5, 58.7, 38.8 at 1 year, 2 years and 3 years, respectively) as compared to other copper devices, which ranged between 82.4 to 84.4 at 1 year, 66.6 to 69.9 at 2 years and 45.4 to 50.4 at 3 years. The difference in continuation rates was mainly due to menstrual disturbances (e.g. amenorrhoea, irregular bleeding) which were higher with LNG IUD (27.9 per 100 users) as compared to the copper devices (13.4-15.4 per 100 users) at 36 months of use. The risk of expulsion ranged between 8.3 to 10.6 per 100 users and was comparable for all the devices. The observations from the present study based on 36 months of experience with different intrauterine devices do not indicate the need to replace CuT 200, the device currently in use in the National Programme.