Poor In Utero Growth, and Reduced ß-Cell Compensation and High Fasting Glucose From Childhood, Are Harbingers of Glucose Intolerance in Young Indians.

OBJECTIVE: India is a double world capital of early-life undernutrition and type 2 diabetes. We aimed to characterize life course growth and metabolic trajectories in those developing glucose intolerance as young adults in the Pune Maternal Nutrition Study (PMNS). RESEARCH DESIGN AND METHODS: PMNS is a community-based intergenerational birth cohort established in 1993, with serial information on parents and children through pregnancy, childhood, and adolescence. We compared normal glucose-tolerant and glucose-intolerant participants for serial growth, estimates of insulin sensitivity and secretion (HOMA and dynamic indices), and ß-cell compensation accounting for prevailing insulin sensitivity. RESULTS: At 18 years (N = 619), 37% of men and 20% of women were glucose intolerant (prediabetes n = 184; diabetes n = 1) despite 48% being underweight (BMI <18.5 kg/m2). Glucose-intolerant participants had higher fasting glucose from childhood. Mothers of glucose-intolerant participants had higher glycemia in pregnancy. Glucose-intolerant participants were shorter at birth. Insulin sensitivity decreased with age in all participants, and those with glucose intolerance had consistently lower compensatory insulin secretion from childhood. Participants in the highest quintile of fasting glucose at 6 and 12 years had 2.5- and 4.0-fold higher risks, respectively, of 18-year glucose intolerance; this finding was replicated in two other cohorts. CONCLUSIONS: Inadequate compensatory insulin secretory response to decreasing insulin sensitivity in early life is the major pathophysiology underlying glucose intolerance in thin rural Indians. Smaller birth size, maternal pregnancy hyperglycemia, and higher glycemia from childhood herald future glucose intolerance, mandating a strategy for diabetes prevention from early life, preferably intergenerationally.

Calibrated delivery drape versus indirect gravimetric technique for the measurement of blood loss after delivery: a randomized trial.

BACKGROUND: Trials of interventions for PPH prevention and treatment rely on different measurement methods for the quantification of blood loss and identification of PPH. This study's objective was to compare measures of blood loss obtained from two different measurement protocols frequently used in studies. METHODS: Nine hundred women presenting for vaginal delivery were randomized to a direct method (a calibrated delivery drape) or an indirect method (a shallow bedpan placed below the buttocks and weighing the collected blood and blood-soaked gauze/pads). Blood loss was measured from immediately after delivery for at least one hour or until active bleeding stopped. RESULTS: Significantly greater mean blood loss was recorded by the direct than by the indirect measurement technique (253.9 mL and 195.3 mL, respectively; difference = 58.6 mL (95% CI: 31-86); p < 0.001). Almost twice as many women in the direct than in the indirect group measured blood loss > 500 mL (8.7% vs. 4.7%, p = 0.02). CONCLUSIONS: The study suggests a real and significant difference in blood loss measurement between these methods. Research using blood loss measurement as an endpoint needs to be interpreted taking measurement technique into consideration. TRIAL REGISTRATION: This study has been registered at clinicaltrials.gov as NCT01885845.

Patterns of fetal growth in a rural Indian cohort and comparison with a Western European population: data from the Pune maternal nutrition study.

OBJECTIVE: The purpose of this study was to describe fetal size on sonography in a rural Indian population and compare it with those in European and urban Indian populations. Methods. Participants were from the Pune Maternal Nutrition Study of India. Fetal growth curves were constructed from serial ultrasound scans at approximately 18, 30, and 36 weeks' gestation in 653 singleton pregnancies. Measurements included femur length (FL), abdominal circumference (AC), biparietal diameter (BPD), and occipitofrontal diameter, from which head circumference (HC) was estimated. Measurements were compared with data from a large population-based study in France and a study of urban mothers in Vellore, south India. RESULTS: Fetal AC and BPD were smaller than the French reference at 18 weeks' gestation (-1.38 and -1.30 SD, respectively), whereas FL and HC were more comparable (-0.77 and -0.59 SD). The deficit remained similar at 36 weeks for AC (-0.97 SD), FL (-0.43 SD), and HC (-0.52 SD) and increased for BPD (-2.3 SD). Sonography at 18 weeks underestimated gestational age compared with the last menstrual period date by a median of -1.4 (interquartile range, -4.6, 1.8) days. The Pune fetuses were smaller, even at the first scan, than the urban Vellore sample. CONCLUSIONS: Fetal size was smaller in a rural Indian population than in European and urban Indian populations, even in mid pregnancy. The deficit varied for different fetal measurements; it was greatest for AC and BPD and least for FL and HC.

Mifepristone followed in 24 hours to 48 hours by misoprostol for late first-trimester abortion.

OBJECTIVE: To investigate the efficacy of mifepristone and misoprostol for the termination of pregnancies in the late first trimester. METHODS: This was a prospective study of 321 women seeking termination of pregnancy with gestations from 64 days to 84 days (+/-3 days) by vaginal ultrasonography. Women were enrolled at three sites: University of Rochester Reproductive Health Program in Rochester, New York; Hung Vuong Hospital in Ho Chi Minh City, Vietnam; and K.E.M. Hospital in Pune, India. Eligible women received 800 mcg of misoprostol vaginally between 24 hours and 48 hours after administration of 200 mg mifepristone. Two additional doses of 400 mcg of misoprostol were administered either orally or vaginally as needed every 3 hours for a maximum of two additional doses (total 1,600 mcg). The primary study outcome measure was complete abortion without surgical intervention. RESULTS: Eighty-nine percent of women who completed the study successfully terminated their pregnancies. Most women were either satisfied (64.8%) or very satisfied (28.6%) with their experience. Ninety-four percent of women reported that they would recommend the procedure to a friend. Most women (90.4%) also agreed they would request a medical abortion if they required another abortion at this gestational age. CONCLUSION: Medical abortion is acceptable and effective in the late first trimester and offers women an acceptable alternative to surgical abortion. LEVEL OF EVIDENCE: II.

Infertility: a label of choice in the case of sexually dysfunctional couples.

OBJECTIVES: In Indian society infertility and sexual dysfunction are stigmatized characteristics. The aim of the study was to explore which label couples who have both complaints, prefer to describe their situation, and whether gender differ occur in this preference. METHODS: A total of 40 couples - all clients of the reproductive health clinic of the King Edward Memorial Hospital in Pune because of problems with infertility and sexual dysfunction - participated in this study. Data were collected by means of interviews. RESULTS: The findings show that sexual activity decreased as the number of childless years increased. However, the interspouse-relationship gets stronger and more supportive. The couples never revealed their sexual dysfunction to others. When the husband was sexually dysfunctional, the couples preferred to label their situation as 'infertility' in order to avoid stigma. CONCLUSION: Issues that are related to sexual dysfunction, sexual behavior, inter-spouse relationship and communication are important aspects into the reality of an infertile couple's life. PRACTICE IMPLICATION: In planning the treatment clinicians should give more attention to the specific cultural context of these aspects.

Increasing maternal parity predicts neonatal adiposity: Pune Maternal Nutrition Study.

OBJECTIVE: This study was undertaken to study the effect of parity on maternal and neonatal characteristics. STUDY DESIGN: Maternal anthropometry, diet, micronutrient status, biochemistry, and physical activity were measured during pregnancy and detailed neonatal size recorded in 770 pregnancies in rural Maharashtra, India. RESULTS: Increasing parity was associated with larger offspring birth weight, skinfold thicknesses, and abdominal circumference, but not head circumference and length. Compared with primiparous women, multiparous women were older, less adipose, and more physically active but had similar education, socioeconomic status, nutritional intake, and weight gain during pregnancy. They had lower circulating concentrations of hemoglobin, albumin, ferritin, glucose, and insulin and lower total leucocyte counts at 18 and 28 weeks' gestation. There was no difference in their husbands' body size. The relationship between maternal parity and neonatal weight and adiposity was significant independent of the difference in maternal characteristics. CONCLUSION: Increasing maternal parity predicts increasing adiposity in the newborn infant. This may result from maternal nutritional, cardiovascular, or immunologic factors.

Misoprostol alone for early abortion: an evaluation of seven potential regimens.

INTRODUCTION: A growing body of literature has shown that misoprostol alone could be effective for early medical abortion. We evaluated seven potential regimens in women up to 56 days of gestation in order to potentially identify an optimal regimen. METHODS: In phase I of the study, women requesting early abortion were randomized to one of three misoprostol regimens (4x400 microg po every 3 h, 2x800 microg po every 6 h, 1x600 pv microg); in phase II, women were randomized to one of two regimens (2x800 microg po every 3 h, 1x800 pv microg). In phase III, we consecutively tested two regimens (800 microg pv wetted with saline repeated after 24 h if intact gestational sac, 2x800 microg pv wetted with saline) to validate previously published results. RESULTS: Although most women experienced some side effects, all regimens were tolerable and acceptable. Five of the seven regimens resulted in complete abortion rates of 60% or less. Only repeated doses of 800 microg pv misoprostol resulted in efficacy exceeding 60%. DISCUSSION: Misoprostol-alone abortion regimens using oral misoprostol are too ineffective for clinical use or further investigation. Regimens with repeated dosing of misoprostol 800 microg pv warrant further study to find the optimal treatment protocol.

Maternal total homocysteine concentration and neonatal size in India.

The smallness of Indian babies is ascribed to small maternal size and their chronic under nutrition. Micronutrient nutrition of the mother may be particularly important. We investigated the relationship between maternal circulating concentrations of total homocysteine (tHcy), vitamin B12 and folate and offspring size at birth. Mothers of full term small for gestation age babies (SGA, gestation and sex specific birth weight <10th centile, N = 30) and mothers of appropriate for gestational age babies (AGA, >10th centile, N = 50) were compared for their body size, plasma tHcy, vitamin B12 and red cell folate concentration at 28 week gestation. Mothers of SGA babies were lighter and shorter than those of AGA babies (P <0.05, both) and had higher plasma tHcy concentration (P<0.01). Total homocysteine concentrations were inversely related to plasma vitamin B12 and red cell folate concentrations (r = approximately -0.5, P <0.01, both). Seventy percent of the women had a low vitamin B12 status (plasma vitamin B12 <150 pmol/L) but none were folate deficient (red cell folate <283 nmol/L). Higher maternal plasma tHcy concentration was significantly associated with lower offspring birth weight (r = -0.28, P<0.05 adjusting for maternal height, weight, gestation at delivery and the baby's gender), this effect was reduced by adjustment for red cell folate concentration. We conclude that maternal vitamin B12 deficiency reflected in plasma tHcy concentration contributes to small size of Indian babies.

Accounting for time: insights from a life-table analysis of the efficacy of medical abortion.

OBJECTIVE: Previously published analyses have ignored the temporal nature of medical abortion and calculated effectiveness as the proportion of abortions that succeed. By using life tables, we incorporate the important element of time to produce unbiased efficacy rates as well as afford insight into the medical abortion process. STUDY DESIGN: Using data on 6568 women from 6 previously published mifepristone-misoprostol medical abortion studies, we generated multidecrement life table efficacy curves and evaluated the cumulative probability of successful medical abortion. RESULTS: Efficacy rates calculated using proportions are biased because of loss to follow-up. Compliance with the medical abortion regimen was high. More than 80% of abortions were complete within a week of receiving mifepristone. Success continued to improve thereafter. Most surgical interventions were unnecessary. CONCLUSION: Follow-up visits can be scheduled within a week of receiving mifepristone; however, aspirations should not be performed routinely if the abortion is not complete.

Differences in efficacy, differences in providers: results from a hazard analysis of medical abortion.

Sample sizes of even the largest medical abortion trials are generally not adequate to provide an understanding of how well the regimen works for subgroups of women, particularly when controlling for factors known to influence efficacy, such as gestational age. By pooling data from four previously published studies of medical abortion and using hazard analyses, we can undertake such an investigation. We find that women with lower gestational ages, women younger than 23 years of age, women with more than 12 years of education and women with no previous induced abortion experience were more likely to experience a successful medical abortion. After taking into account demographic factors, we find that significant differences in efficacy persist across study sites, indicating that differences in providers' tendency to intervene by performing vacuum aspiration vary across medical abortion providers.

Mifepristone-misoprostol abortion: a trial in rural and urban Maharashtra, India.

As several important policy questions remain regarding the use of medical abortion in developing countries, we investigated the safety, efficacy, and acceptability of mifepristone-misoprostol abortion in the outpatient family planning departments of two urban hospitals and one rural hospital in India. Nine-hundred women (with gestations of < or =63 days in the urban sites and < or =56 days in the rural site) received 600 mg mifepristone followed 48 h later by 400 microg oral misoprostol in the clinic. Four point four percent or fewer urban women and 1.0% rural women were lost to follow-up. Perfect and typical-use failure rates were low at all sites. While rural women reported fewer side effects at all sites, the vast majority of women were satisfied with their medical abortions. Medical abortion can be offered safely, effectively, and acceptably in the outpatient family planning departments of urban and rural hospitals in India.