Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo-controlled clinical trial.

OBJECTIVE: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0. DESIGN: Randomised double-blind placebo-controlled trial. SETTING: Rural southern India. POPULATION: Pregnant women with a singleton fetus between 13+0/7 weeks and 20+6/7 weeks. METHODS: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo. MAIN OUTCOME MEASURES: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks. RESULTS: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death. CONCLUSION: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0. TWEETABLE ABSTRACT: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0.

Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double-blind randomised controlled trial.

OBJECTIVE: Sublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 µg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin. DESIGN: Double-blind randomised controlled trial. SETTING: A teaching hospital: J N Medical College, Belgaum, India. SAMPLE: A cohort of 652 consenting eligible pregnant women admitted to the labour room. METHODS: Subjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer-generated randomisation. Chi-square and bootstrapped Student's t-tests were used to test categorical and continuous outcomes, respectively. MAIN OUTCOME MEASURES: Measured mean postpartum blood loss and haemorrhage (PPH, loss ≥ 500 ml), >10% pre- to post-partum decline in haemoglobin, and reported side effects. RESULTS: The mean blood loss with sublingual misoprostol was 192 ± 124 ml (n=321) and 366 ± 136 ml with oxytocin IM (n=331, P ≤ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin (P=0.002). No woman lost ≥ 1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively (P ≤ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group. CONCLUSION: Unlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results.

Community Kangaroo Mother Care: implementation and potential for neonatal survival and health in very low-income settings.

OBJECTIVE: Immediate Kangaroo Mother Care (KMC), an intervention following childbirth whereby the newborn is placed skin-to-skin (STS) on mother's chest to promote thermal regulation, breastfeeding and maternal-newborn bonding, is being taught in very low-income countries to improve newborn health and survival. Existing data are reviewed to document the association between community-based KMC (CKMC) implementation and its potential benefits. STUDY DESIGN: New analyses of the sole randomized controlled study of CKMC in Bangladesh and others' experiences with immediate KMC are presented. RESULT: Newborns held STS less than 7 h per day in the first 2 days of life do not experience substantially better health or survival than babies without being held STS. CONCLUSION: Most women who were taught CKMC hold their newborns STS, but do so in a token manner unlikely to improve health or survival. Serious challenges exist to provide effective training and postpartum support to achieve adequate STS practices. These challenges must be overcome before scaling up.

What measured blood loss tells us about postpartum bleeding: a systematic review.

BACKGROUND: Meta-analyses of postpartum blood loss and the effect of uterotonics are biased by visually estimated blood loss. OBJECTIVES: To conduct a systematic review of measured postpartum blood loss with and without prophylactic uterotonics for prevention of postpartum haemorrhage (PPH). SEARCH STRATEGY: We searched Medline and PubMed terms (labour stage, third) AND (ergonovine, ergonovine tartrate, methylergonovine, oxytocin, oxytocics or misoprostol) AND (postpartum haemorrhage or haemorrhage) and Cochrane reviews without any language restriction. SELECTION CRITERIA: Refereed publications in the period 1988-2007 reporting mean postpartum blood loss, PPH (> or =500 ml) or severe PPH (> or =1000 ml) following vaginal births. DATA COLLECTION AND ANALYSIS: Raw data were abstracted into Excel by one author and then reviewed by a co-author. Data were transferred to SPSS 17.0, and copied into RevMan 5.0 to perform random effects meta-analysis. MAIN RESULTS: The distribution of average blood loss (29 studies) is similar with any prophylactic uterotonic, and is lower than without prophylaxis. Compared with no uterotonic, oxytocin and misoprostol have lower PPH (OR 0.43, 95% CI 0.23-0.81; OR 0.73, 95% CI 0.50-1.08, respectively) and severe PPH rates (OR 0.61, 95% CI 0.29-1.29; OR 0.74, 95% CI 0.52-1.04, respectively). Oxytocin has lower PPH (OR 0.65, 95% CI 0.60-0.70) and severe PPH (OR 0.71, 95% CI 0.56-0.91) rates than misoprostol, but not in developing countries. CONCLUSION: Oxytocin is superior to misoprostol in hospitals. Misoprostol substantially lowers PPH and severe PPH. A sound assessment of the relative merits of the two drugs is needed in rural areas of developing countries, where most PPH deaths occur.

The etiology of maternal mortality in developing countries: what do verbal autopsies tell us?

OBJECTIVE: To reassess the practical value of verbal autopsy data, which, in the absence of more definitive information, have been used to describe the causes of maternal mortality and to identify priorities in programmes intended to save women's lives in developing countries. METHODS: We reanalysed verbal autopsy data from a study of 145 maternal deaths that occurred in Guerrero, Querétaro and San Luis Potosí, Mexico, in 1995, taking into account other causes of death and the WHO classification system. The results were also compared with information given on imperfect death certificates. FINDINGS: The reclassification showed wide variations in the attribution of maternal deaths to single specific medical causes. CONCLUSION: The verbal autopsy methodology has inherent limitations as a means of obtaining histories of medical events. At best it may reconfirm the knowledge that mortality among poor women with little access to medical care is higher than that among wealthier women who have better access to such care.

Validity of women's self-reported obstetric complications in rural Ghana.

This retrospective study assessed the utility of women's self-reports to identify obstetric complications in rural Ghana. All consenting obstetric and postpartum inpatients, presenting from the seventh month of gestation to 42 days postpartum, were interviewed at the Holy Family Hospital, Techiman and were asked about their signs and symptoms. A combination of clinical examination and laboratory testing of urine and blood samples was used for determining case status. Self-reported obstetric complications of 340 women were compared with the corresponding diagnostic status for their sensitivity, specificity, predictive value, and test-efficiency. Using algorithms that could not be practically applied at the community level, self-reported symptoms correctly identified the majority (75%) of complicated and uncomplicated pregnancies, but missed one-quarter of cases requiring emergency obstetric care. The positive predictive value of 50% indicates that women's self-reported symptoms should not be used in estimating the incidence of these conditions or in identifying women requiring referral in this population.

The power of information and contraceptive choice in a family planning setting in Mexico.

OBJECTIVES: This study measured the effect of information about family planning methods and STD risk factors and prevention, together with personal choice on the selection of intrauterine devices (IUDs) by clients with cervical infection. METHODS: We conducted a randomised, controlled trial in which family planning clients were assigned to one of two groups, the standard practice (control) group in which the provider selected the woman's contraceptive and the information and choice (intervention) group. The study enrolled 2107 clients in a family planning clinic in Mexico City. RESULTS: Only 2.1% of the clients had gonorrhoea or chlamydial infections. Significantly fewer women in the intervention group selected the IUD than the proportion for whom the IUD was recommended in the standard care group by clinicians (58.2% v 88.2%, p = 0.0000). The difference was even more pronounced among infected women: 47.8% v 93.2% (intervention v control group, p = 0.0006). CONCLUSIONS: The intervention increased the selection of condoms and reduced the selection of IUDs, especially among women with cervical infections, for whom IUD insertion is contraindicated.

Reduction of the cesarean delivery rate in Ecuador.

OBJECTIVE: This quasi-experimental study tested a method to safely reduce the rate of cesarean delivery in Ecuador. METHOD: Hospital policy was modified to provide co-management for cesarean candidates at the major maternity hospital in Quito. Cesarean rates before (n=14743) and after (n=12351) the intervention were compared by chi-square and multiple logistic regression with other major maternity hospitals (before, n=12514; after, n=9590). Characteristics of cesarean candidates who had vaginal or cesarean deliveries in the intervention hospital were compared by chi-square (n=1584). RESULT: Cesarean rates declined by 4.5% (P<0.001) in the intervention hospital. A smaller (2.1%, P<0.01) reduction occurred in the other major public hospital in Quito where students of the co-principal investigator attempted to reduce cesarean delivery. Cesarean rates were unchanged in the public maternity hospitals of other major cities. CONCLUSION: Case co-management, a simple, locally appropriate, and inexpensive intervention, safely reduced surgical delivery, hospital stay and cost of care.

Screening and syndromic approaches to identify gonorrhea and chlamydial infection among women.

The standard diagnostic tools to identify sexually transmitted infections are often expensive and have laboratory and infrastructure requirements that make them unavailable to family planning and primary health-care clinics in developing countries. Therefore, inexpensive, accessible tools that rely on symptoms, signs, and/or risk factors have been developed to identify and treat reproductive tract infections without the need for laboratory diagnostics. Studies were reviewed that used standard diagnostic tests to identify gonorrhea and cervical chlamydial infection among women and that provided adequate information about the usefulness of the tools for screening. Aggregation of the studies' results suggest that risk factors, algorithms, and risk scoring for syndromic management are poor indicators of gonorrhea and chlamydial infection in samples of both low and high prevalence and, consequently, are not effective mechanisms with which to identify or manage these conditions. The development and evaluation of other approaches to identify gonorrhea and chlamydial infections, including inexpensive and simple laboratory screening tools, periodic universal treatment, and other alternatives must be given priority.

Identifying areas with vitamin A deficiency: the validity of a semiquantitative food frequency method.

OBJECTIVES: The prevalence of vitamin A deficiency has traditionally been assessed through xerophthalmia or biochemical surveys. The cost and complexity of implementing these methods limits the ability of nonresearch organizations to identify vitamin A deficiency. This study examined the validity of a simple, inexpensive food frequency method to identify areas with a high prevalence of vitamin A deficiency. METHODS: The validity of the method was tested in 15 communities, 5 each from the Philippines, Guatemala, and Tanzania. Serum retinol concentrations of less than 20 micrograms/dL defined vitamin A deficiency. RESULTS: Weighted measures of vitamin A intake six or fewer times per week and unweighted measures of consumption of animal sources of vitamin A four or fewer times per week correctly classified seven of eight communities as having a high prevalence of vitamin A deficiency (i.e., 15% or more preschool-aged children in the community had the deficiency) (sensitivity = 87.5%) and four of seven communities as having a low prevalence (specificity = 57.1%). CONCLUSIONS: This method correctly classified the vitamin A deficiency status of 73.3% of the communities but demonstrated a high false-positive rate (42.9%).

Women's nutritional status, iron consumption and weight gain during pregnancy in relation to neonatal weight and length in West Java, Indonesia.

Pregnant and non-pregnant women in Indramayu, West Java were examined for nutritional status, using anthropometric indicators. For the pregnant women, longitudinal data on nutritional status, iron consumption and weight gain were examined in relation to neonatal weight and length. Comparing the non-pregnant women's average nutritional status with reference tables for height, weight and MUAC, they placed at the 25th percentile or less on all indicators. Using original formulae to estimate pre-pregnancy weight and pregnancy weight gain, the study showed that 18% of pregnant women had a pre-pregnancy weight of under 40 kg and the average pregnancy weight gain was under 9 kg. Comparing estimated pregnancy weight gain with the amount of weight gain needed to compensate for generally low pre-pregnancy weight, only about 9% of women gained adequately. In multiple regression models that controlled for other maternal and neonatal factors, iron consumption during pregnancy was a significant predictor of full-term (37 weeks or more) neonatal weight (P = 0.01) and length (P = 0.01). Consumption of one or more tablets (200 mg ferrous sulfate and 0.25 mg folic acid) per week by women during pregnancy was associated with increased neonatal weight (by 172 g on average) and length (by 1 cm on average). Adequate weight gain during pregnancy and maternal height also contributed to the specification of the neonatal weight model (P = 0.07 for both). In the neonatal length model, maternal height was also nearly significant (P = 0.03). The same models did not explain the variability in neonatal weight and length in the pre-term group (< 37 weeks gestation).

Kangaroo mother method: randomised controlled trial of an alternative method of care for stabilised low-birthweight infants. Maternidad Isidro Ayora Study Team.

Because resources for care of low-birthweight (LBW) infants in developing countries are scarce, the Kangaroo mother method (KMM) was developed. The infant is kept upright in skin-to-skin contact with the mother's breast. Previous studies reported several benefits with the KMM but interpretation of their findings is limited by small size and design weaknesses. We have done a longitudinal, randomised, controlled trial at the Isidro Ayora Maternity Hospital in Quito, Ecuador. Infants with LBW (< 2000 g) who satisfied out-of-risk criteria of tolerance of food and weight stabilisation were randomly assigned to KMM and control (standard incubator care) groups (n = 128 and 147, respectively). During 6 months of follow-up the KMM group had a significantly lower rate than the control group of serious illness (lower-respiratory-tract disorders, apnoea, aspiration, pneumonia, septicaemia, general infections; 7 [5%] vs 27 [18%], p < 0.002), although differences between the groups in less severe morbidity were not significant. There was no significant difference in growth or in the proportion of women breastfeeding, perhaps because the proportion breastfeeding was high in both groups owing to strong promotion. Mortality was the same in both groups; most deaths occurred during the stabilisation period before randomisation. KMM mothers made more unscheduled clinic visits than control mothers but their infants had fewer re-admissions and so the cost of care was lower with the KMM. Since the eligibility criteria excluded nearly 50% of LBW infants from the study, the KMM is not universally applicable to these infants. The benefits might be greater in populations where breastfeeding is not so common.

Risk factors for vitamin A deficiency in rural areas of the Philippines.

A survey of vitamin A deficiency was conducted in January and February 1991 on the island of Mindanao in the Philippines. Demographic, serum retinol, conjunctival impression cytology (CIC), anthropometric, and dietary data were collected from 248 preschool children in five randomly selected rural communities on the outskirts of Davao City. Twenty-nine per cent [95 per cent confidence interval (CI) 23-35 per cent] of preschool children had serum retinol levels below 20 micrograms/dl. Nearly 6 per cent (95 per cent CI 3-9 per cent) had serum retinol levels below 10 micrograms/dl. Thirty-two per cent (95 per cent CI 25-38 per cent) had abnormal CIC findings. The correlation between serum retinol and CIC results was poor. Recent history of diarrheal disease, reported night blindness, maternal education less than 9 years, and infrequent consumption of eggs, mangoes, and liver were associated with increased risk of vitamin A deficiency.

The National WIC Evaluation: evaluation of the Special Supplemental Food Program for Women, Infants, and Children. I. Background and introduction.

The Special Supplemental Food Program for Women, Infants, and Children (WIC) aims to improve the nutrition and health of low-income, nutritionally at-risk pregnant women and preschool children with supplemental food, nutrition education, and coordination of health care. Started in 1972, it recently served greater than 3.4 million persons monthly and at a cost of $1.66 billion annually. The National WIC Evaluation (NWE) consisted of four studies: The historical study estimated changes in birth outcome attributable to WIC from 1972 to 1980 in 19 states and the District of Columbia from WIC program data and vital statistics. The longitudinal study of pregnant women compared dietary intake, weight gain, anthropometry, duration of gestation, birth weight, and infant length and head circumference between a representative national sample of WIC participants and economically comparable women. The cross-sectional study of preschool children related WIC to dietary intake, anthropometry, and psychological development. The food expenditures study estimated the impact of WIC on family grocery and other food expenditures.

The National WIC Evaluation: evaluation of the Special Supplemental Food Program for Women, Infants, and Children. II. Review of past studies of WIC.

We reviewed past work relating WIC benefits to birth weight, perinatal and infant survival, anemia, child growth, and dietary intake. Despite many uncertainties, the probable range of reduction in the rate of low birth weight was approximately 1-2% and the increase in mean birth weight ranged from 0 to approximately 60 g. There was too little information to securely estimate effects of WIC on perinatal and infant mortality nor on the dietary intake of women or children. Although the number of studies was small, there probably were important effects of WIC on rates of childhood anemia. There is too little evidence to come to any conclusion on effects during pregnancy. There is little evidence that the WIC program has affected children's linear growth.