Global inequities in dietary calcium intake during pregnancy: a systematic review and meta-analysis.

BACKGROUND: Evidence shows that adequate calcium intake during pregnancy reduces the risk of hypertensive disorders of pregnancy. In most low- and middle-income countries (LMICs) the daily calcium intake is well below recommendations. Mapping calcium intake during pregnancy worldwide and identifying populations with low calcium intake will provide the evidence base for more targeted actions to improve calcium intake. OBJECTIVE: To assess dietary calcium intake during pregnancy worldwide. SEARCH STRATEGY: MEDLINE and EMBASE (from July 2004 to November 2017). SELECTION CRITERIA: Cross-sectional, cohort, and intervention studies reporting calcium intake during pregnancy. DATA COLLECTION AND ANALYSIS: Five reviewers working in pairs independently performed screening, extraction, and quality assessment. We reported summary measures of calcium intake and calculated the weighted arithmetic mean for high-income countries (HICs) and LMICs independently, and for geographic regions, among studies reporting country of recruitment, mean intake, and total number of participants. When available, inadequate intakes were reported. MAIN RESULTS: From 1880 citations 105 works met the inclusion criteria, providing data for 73 958 women in 37 countries. The mean calcium intake was 948.3 mg/day (95% CI 872.1-1024.4 mg/day) for HICs and 647.6 mg/day (95% CI 568.7-726.5 mg/day) for LMICs. Calcium intakes below 800 mg/day were reported in five (29%) countries from HICs and in 14 (82%) countries from LMICs. CONCLUSION: These results are consistent with a lack of improvement in calcium dietary intake during pregnancy and confirm the gap between HICs and LMICs, with alarmingly low intakes recorded for pregnant women in LMICs. From the public health perspective, in the absence of specific local data, calcium supplementation of pregnant women in these countries should be universal. TWEETABLE ABSTRACT: Despite dietary recommendations, women in LMICs face pregnancy with diets low in calcium.

Stillbirth rates in 20 countries of Latin America: an ecological study.

OBJECTIVE: To describe country-level stillbirth rates and their change over time in Latin America, and to measure the association of stillbirth rates with socio-economic and health coverage indicators in the region. DESIGN: Ecological study. SETTING: 20 countries of Latin America. POPULATION OR SAMPLE: Aggregated data from pregnant women with countries as units of analysis. METHODS: We used stillbirth estimates, and socio-economic and healthcare coverage indicators reported from 2006 to 2016 from UNICEF, United Nations Development Programme and World Bank datasets. We calculated Spearman's correlation coefficients between stillbirths rates and socioeconomic and health coverage indicators. MAIN OUTCOME MEASURES: National estimates of stillbirth rates in each country. RESULTS: The estimated stillbirth rate for Latin America for 2015 was 8.1 per 1000 births (range 3.1-24.9). Seven Latin America countries had rates higher than 10 stillbirths per 1000 births. The average annual reduction rate for the region was 2% (range 0.1-3.8%), with the majority of Latin America countries ranging between 1.5 and 2.5%. National stillbirth rates were correlated to: women's schooling (rS = -0.7910), gross domestic product per capita (rS = -0.8226), fertility rate (rS = 0.6055), urban population (rS = -0.6316), and deliveries at health facilities (rS = -0.6454). CONCLUSIONS: Country-level estimated stillbirth rates in Latin America varied widely in 2015. The trend and magnitude of reduction in stillbirth rates between 2000 and 2015 was similar to the world average. Socio-economic and health coverage indicators were correlated to stillbirth rates in Latin America. TWEETABLE ABSTRACT: Stillbirth rates decreased in Latin America but remain relatively high, with wide variations among countries.

Obstetrical providers' preferred mode of delivery and attitude towards non-medically indicated caesarean sections: a cross-sectional study.

OBJECTIVE: To describe obstetrical providers' delivery preferences and attitudes towards caesarean section without medical indication, including on maternal request, and to examine the association between provider characteristics and preferences/attitudes. DESIGN: Cross-sectional study. SETTING: Two public and two private hospitals in Argentina. POPULATION: Obstetrician-gynaecologists and midwives who provide prenatal care and/or labour/delivery services. METHODS: Providers in hospitals with at least 1000 births per year completed a self-administered, anonymous survey. MAIN OUTCOME MEASURES: Provider delivery preference for low-risk women, perception of women's preferred delivery method, support for a woman's right to choose her delivery method and willingness to perform caesarean section on maternal request. RESULTS: 168 providers participated (89.8% coverage rate). Providers (93.2%) preferred a vaginal delivery for their patients in the absence of a medical indication for caesarean section. Whereas 74.4% of providers supported their patient's right to choose a delivery method in the absence of a medical indication for caesarean section and 66.7% would perform a caesarean section upon maternal request, only 30.4% would consider a non-medically indicated caesarean section for their own personal delivery or that of their partner. In multivariate adjusted analysis, providers in the private sector [odds ratio (OR) 4.70, 95% CI 1.19-18.62] and obstetrician-gynaecologists (OR 4.37, 95% CI 1.58-12.09) were more willing than either providers working in the public/both settings or midwives to perform a caesarean section on maternal request. CONCLUSIONS: Despite the ethical debate surrounding non-medically indicated caesarean sections, we observe very high levels of support, especially by providers in the private sector and obstetrician-gynaecologists, as aligned with the high caesarean section rates in Argentina. TWEETABLE ABSTRACT: Non-medically indicated c-section? 74% of sampled Argentine OB providers support women's right to choose.

Care in subsequent pregnancies following stillbirth: an international survey of parents.

OBJECTIVE: To assess the frequency of additional care, and parents' perceptions of quality, respectful care, in pregnancies subsequent to stillbirth. DESIGN: Multi-language web-based survey. SETTING: International. POPULATION: A total of 2716 parents, from 40 high- and middle-income countries. METHODS: Data were obtained from a broader survey of parents' experiences following stillbirth. Data were analysed using descriptive statistics and stratified by geographic region. Subgroup analyses explored variation in additional care by gestational age at index stillbirth. MAIN OUTCOME MEASURES: Frequency of additional care, and perceptions of quality, respectful care. RESULTS: The majority (66%) of parents conceived their subsequent pregnancy within 1 year of stillbirth. Additional antenatal care visits and ultrasound scans were provided for 67% and 70% of all parents, respectively, although there was wide variation across geographic regions. Care addressing psychosocial needs was less frequently provided, such as additional visits to a bereavement counsellor (10%) and access to named care provider's phone number (27%). Compared with parents whose stillbirth occurred at ≤ 29 weeks of gestation, parents whose stillbirth occurred at ≥ 30 weeks of gestation were more likely to receive various forms of additional care, particularly the option for early delivery after 37 weeks. Around half (47-63%) of all parents felt that elements of quality, respectful care were consistently applied, such as spending enough time with parents and involving parents in decision-making. CONCLUSIONS: Greater attention is required to providing thoughtful, empathic and collaborative care in all pregnancies following stillbirth. Specific education and training for health professionals is needed. TWEETABLE ABSTRACT: More support for providing quality care in pregnancies after stillbirth is needed. PLAIN LANGUAGE SUMMARY: Study rationale and design More than two million babies are stillborn every year. Most parents will conceive again soon after having a stillborn baby. These parents are more likely to have another stillborn baby in the next pregnancy than parents who have not had a stillborn baby before. The next pregnancy after stillbirth is often an extremely anxious time for parents, as they worry about whether their baby will survive. In this study we asked 2716 parents from 40 countries about the care they received during their first pregnancy after stillbirth. Parents were recruited mainly through the International Stillbirth Alliance and completed on online survey that was available in six languages. Findings Parents often had extra antenatal visits and extra ultrasound scans in the next pregnancy, but they rarely had extra emotional support. Also, many parents felt their care providers did not always listen to them and spend enough time with them, involve them in decisions, and take their concerns seriously. Parents were more likely to receive various forms of extra care in the next pregnancy if their baby had died later in pregnancy compared to earlier in pregnancy. Limitations In this study we only have information from parents who were able and willing to complete an online survey. Most of the parents were involved in charity and support groups and most parents lived in developed countries. We do not know how well the findings relate to other parents. Finally, our study does not include parents who may have tried for another pregnancy but were not able to conceive. Potential impact This study can help to improve care through the development of best practice guidelines for pregnancies following stillbirth. The results suggest that parents need better emotional support in these pregnancies, and more opportunities to participate actively in decisions about care. Extra support should be available no matter how far along in pregnancy the previous stillborn baby died.

The effect of calcium supplementation on blood pressure in non-pregnant women with previous pre-eclampsia: An exploratory, randomized placebo controlled study.

BACKGROUND: Epidemiological findings suggest that the link between poverty and pre-eclampsia might be dietary calcium deficiency. Calcium supplementation has been associated with a modest reduction in pre-eclampsia, and also in blood pressure (BP). METHODS: This exploratory sub-study of the WHO Calcium and Pre-eclampsia (CAP) trial aims to determine the effect of 500mg/day elemental calcium on the blood pressure of non-pregnant women with previous pre-eclampsia. Non-pregnant women with at least one subsequent follow-up trial visit at approximately 12 or 24weeks after randomization were included. RESULTS: Of 836 women randomized by 9 September 2014, 1st visit data were available in 367 women of whom 217 had previously had severe pre-eclampsia, 2nd visit data were available in 201 women. There was an overall trend to reduced BP in the calcium supplementation group (1-2.5mmHg) although differences were small and not statistically significant. In the subgroup with previous severe pre-eclampsia, the mean diastolic BP change in the calcium group (-2.6mmHg) was statistically larger than in the placebo group (+0.8mmHg), (mean difference -3.4, 95% CI -0.4 to -6.4; p=0.025). The effect of calcium on diastolic BP at 12weeks was greater than in those with non-severe pre-eclampsia (p=0.020, ANOVA analysis). CONCLUSIONS: There is an overall trend to reduced BP but only statistically significant in the diastolic BP of women with previous severe pre-eclampsia. This is consistent with our hypothesis that this group is more sensitive to calcium supplementation, however results need to be interpreted with caution.

Low-dose calcium supplementation for preventing pre-eclampsia: a systematic review and commentary.

BACKGROUND: Epidemiological data link low dietary calcium with pre-eclampsia. Current recommendations are for 1.5-2 g/day calcium supplementation for low-intake pregnant women, based on randomised controlled trials of ≥1 g/day calcium supplementation from 20 weeks of gestation. This is problematic logistically in low-resource settings; excessive calcium may be harmful; and 20 weeks may be too late to alter outcomes. OBJECTIVES: To review the impact of lower dose calcium supplementation on pre-eclampsia risk. SEARCH STRATEGY AND SELECTION CRITERIA: We searched PubMed and the Cochrane Pregnancy and Childbirth Group trials register. DATA COLLECTION AND ANALYSIS: Two authors extracted data from eligible randomised and quasi-randomised trials of low-dose calcium (LDC, <1 g/day), with or without other supplements. MAIN RESULTS: Pre-eclampsia was reduced consistently with LDC with or without co-supplements (nine trials, 2234 women, relative risk [RR] 0.38; 95% confidence interval [95% CI] 0.28-0.52), as well as for subgroups: LDC alone (four trials, 980 women, RR 0.36; 95% CI 0.23-0.57]); LDC plus linoleic acid (two trials, 134 women, RR 0.23; 95% CI 0.09-0.60); LDC plus vitamin D (two trials, 1060 women, RR 0.49; 0.31-0.78) and a trend for LDC plus antioxidants (one trial, 60 women, RR 0.24; 95% CI 0.06-1.01). Overall results were consistent with the single quality trial of LDC alone (171 women, RR 0.30; 95% CI 0.06-1.38). LDC plus antioxidants commencing at 8-12 weeks tended to reduce miscarriage (one trial, 60 women, RR 0.06; 95% CI 0.00-1.04). CONCLUSIONS: These limited data are consistent with LDC reducing the risk of pre-eclampsia; confirming this in sufficiently powered randomised controlled trials would have implications for current guidelines and their global implementation.

Women's preference for caesarean section: a systematic review and meta-analysis of observational studies.

BACKGROUND: The striking increase in caesarean section rates in middle- and high-income countries has been partly attributed to maternal request. We conducted a systematic review and meta-analysis of women's preferences for caesarean section. OBJECTIVES: To review the published literature on women's preferences for caesarean section. SEARCH STRATEGY: A systematic search of MEDLINE, EMBASE, LILACS and PsychINFO was performed. References of all included articles were examined. SELECTION CRITERIA: We included studies that quantitatively evaluated women's preferences for caesarean section in any country. We excluded articles assessing health providers' preferences and qualitative studies. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened abstracts of all identified citations, selected potentially eligible studies, and assessed their full-text versions. We conducted a meta-analysis of proportions, and a meta-regression analysis to determine variables significantly associated with caesarean section preference. MAIN RESULTS: Thirty-eight studies were included (n = 19,403). The overall pooled preference for caesarean section was 15.6% (95% CI 12.5-18.9). Higher preference for caesarean section was reported in women with a previous caesarean section versus women without a previous caesarean section (29.4%; 95% CI 24.4-34.8 versus 10.1%; 95% CI 7.5-13.1), and those living in a middle-income country versus a high-income country (22.1%; 95% CI 17.6-26.9 versus 11.8%; 95% CI 8.9-15.1). AUTHORS' CONCLUSIONS: Only a minority of women in a wide variety of countries expressed a preference for caesarean delivery. Further research is needed to better estimate the contribution of women's demand to the rising caesarean section rates.

Bed rest during pregnancy for preventing miscarriage.

BACKGROUND: Miscarriage is pregnancy loss before 23 weeks of gestational age and it happens in 10% to 15% of pregnancies depending on maternal age and parity. It is associated with chromosomal defects in about a half or two thirds of cases. Many interventions have been used to prevent miscarriage but bed rest is probably the most commonly prescribed especially in cases of threatened miscarriage and history of previous miscarriage. Since the etiology of miscarriage in most of the cases is not related to an excess of activity, it is unlikely that bed rest could be an effective strategy to reduce spontaneous miscarriage. OBJECTIVES: To evaluate the effect of prescription of bed rest during pregnancy to prevent miscarriage in women at high risk of miscarriage. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (July 2004). In addition, we searched The Cochrane Central Register of Controlled Trials (The Cochrane Library), MEDLINE, POPLINE, LILACS and EMBASE. SELECTION CRITERIA: We included all published, unpublished and ongoing randomized trials with reported data which compare clinical outcomes in pregnant women who were prescribed bed rest in hospital or at home for preventing miscarriage compared with alternative care or no intervention. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the methodological quality of included trials using the methods described in the Cochrane Reviewers' Handbook. Studies were included irrespective of their methodological quality. MAIN RESULTS: Only two studies including 84 women were identified. There was no statistically significant difference in the risk of miscarriage in the bed rest group versus the no bed rest group (placebo or other treatment) (relative risk (RR) 1.54, 95% confidence interval (CI) 0.92 to 2.58). Neither bed rest in hospital nor bed rest at home showed a significant difference in the prevention of miscarriage. There was a higher risk of miscarriage in those women in the bed rest group than in those in the human chorionic gonadotrophin therapy group with no bed rest (RR 2.50, 95% CI 1.22 to 5.11). It seems that the small number of participants included in these studies is a main factor to make this analysis inconclusive. AUTHORS' CONCLUSIONS: There is insufficient evidence of high quality that supports a policy of bed rest in order to prevent miscarriage in women with confirmed fetal viability and vaginal bleeding in first half of pregnancy.

Effect of the interpregnancy interval after an abortion on maternal and perinatal health in Latin America.

OBJECTIVE: To investigate whether the length of the interval between an abortion and the next pregnancy is associated with increased risks of adverse maternal and perinatal outcomes in Latin America. METHOD: Retrospective cross-sectional study using information from 258,108 women delivering singleton infants and whose previous pregnancy resulted in abortion recorded in the Perinatal Information System database of the Latin American Centre for Perinatology and Human Development, Montevideo, Uruguay, between 1985 and 2002. Adjusted odds ratios were obtained through logistic regression analysis. RESULT: Compared with the post-abortion interpregnancy intervals of 18 to 23 months, intervals shorter than 6 months were significantly associated with increased risks of maternal anemia, premature rupture of membranes, low birth weight, very low birth weight, preterm delivery, and very preterm delivery. CONCLUSION: In Latin America, post-abortion interpregnancy intervals shorter than 6 months are independently associated with increased risks of adverse maternal and perinatal outcomes in the next pregnancy. DEFINITION: Post-abortion interpregnancy interval (PAII): the time elapsed between the day of the abortion and the first day of the last menstrual period for the index pregnancy.

Bed rest in singleton pregnancies for preventing preterm birth.

BACKGROUND: Bed rest in hospital or at home is widely recommended for the prevention of preterm birth. This advice is based on the observation that hard work and hard physical activity during pregnancy could be associated with preterm birth and with the idea that bed rest could reduce uterine activity. However, bed rest may have some adverse effects on other outcomes. OBJECTIVES: To evaluate the effect of prescription of bed rest in hospital or at home for preventing preterm birth in pregnant women at high risk of preterm birth. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (July 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2003), MEDLINE (July 2003), LILACS (July 2003), EMBASE (July 2003), POPLINE (July 2003) and bibliographies of relevant papers. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials with reported data that assess clinical outcomes in women at high risk of spontaneous preterm birth who were prescribed bed rest in hospital or at home for preventing preterm birth, and their babies. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility, trial quality and extracted data. MAIN RESULTS: One study met the inclusion criteria (1266 women). This trial has uncertain methodological quality due to lack of reporting. Four hundred and thirty-two women were prescribed bed rest at home and a total of 834 women received a placebo (412) or no intervention (422). Preterm birth before 37 weeks was similar in both groups (7.9% in the intervention group versus 8.5% in the control group), and the relative risk was 0.92 with a 95% confidence interval from 0.62 to 1.37. No other results were available. REVIEWER'S CONCLUSIONS: There is no evidence, either supporting or refuting the use of bed rest at home or in hospital, to prevent preterm birth. Although bed rest in hospital or at home is widely used as the first step of treatment, there is no evidence that this practice could be beneficial. Due to the potential adverse effects that bed rest could have on women and their families, and the increased costs for the healthcare system, clinicians should not routinely advise women to rest in bed to prevent preterm birth. Potential benefits and harms should be discussed with women facing an increased risk of preterm birth. Appropriate research is mandatory. Future trials should evaluate both the effectiveness of bed rest, and the effectiveness of the prescription of bed rest, to prevent preterm birth.

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants.

BACKGROUND: Kangaroo mother care (KMC), defined as skin-to-skin contact between a mother and her newborn, frequent and exclusive or nearly exclusive breastfeeding, and early discharge from hospital, has been proposed as an alternative to conventional neonatal care for low birthweight (LBW) infants. OBJECTIVES: To determine whether there is evidence to support the use of KMC in LBW infants as an alternative to conventional care after the initial period of stabilization with conventional care. SEARCH STRATEGY: We used the standard search strategy of the Neonatal Review Group of the Cochrane Collaboration. MEDLINE, EMBASE, LILACS, POPLINE and CINAHL databases (to December 2002), and the Cochrane Controlled Trials Register (The Cochrane Library), were searched using the key words terms "kangaroo mother care" or "kangaroo care" or "kangaroo mother method" or "skin-to-skin contact" and "infants" or "low birthweight infants". SELECTION CRITERIA: Randomized trials comparing KMC and conventional neonatal care in LBW infants. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. Statistical analysis was conducted using the standard Cochrane Collaboration methods. MAIN RESULTS: Three studies, involving 1362 infants, were included. All the trials were conducted in developing countries. The studies were of moderate to poor methodological quality. The most common shortcomings were in the areas of blinding procedures for those who collected the outcomes measures, handling of drop outs, and completeness of follow-up. The great majority of results consist of results of a single trial. KMC was associated with the following reduced risks: nosocomial infection at 41 weeks' corrected gestational age (relative risk 0.49, 95% confidence interval 0.25 to 0.93), severe illness (relative risk 0.30, 95% confidence interval 0.14 to 0.67), lower respiratory tract disease at 6 months follow-up (relative risk 0.37, 95% confidence interval 0.15 to 0.89), not exclusively breastfeeding at discharge (relative risk 0.41, 95% confidence interval 0.25 to 0.68), and maternal dissatisfaction with method of care (relative risk 0.41, 95% confidence interval 0.22 to 0.75). KMC infants had gained more weight per day by discharge (weighted mean difference 3.6 g/day, 95% confidence interval 0.8 to 6.4). Scores on mother's sense of competence according to infant stay in hospital and admission to NICU were better in KMC than in control group (weighted mean differences 0.31 [95% confidence interval 0.13 to 0.50] and 0.28 [95% confidence interval 0.11 to 0.46], respectively). Scores on mother's perception of social support according to infant stay in NICU were worse in KMC group than in control group (weighted mean difference -0.18 (95% confidence interval -0.35 to -0.01). Psychomotor development at 12 months' corrected age was similar in the two groups. There was no evidence of a difference in infant mortality. However, serious concerns about the methodological quality of the included trials weaken credibility in these findings. REVIEWER'S CONCLUSIONS: Although KMC appears to reduce severe infant morbidity without any serious deleterious effect reported, there is still insufficient evidence to recommend its routine use in LBW infants. Well designed randomized controlled trials of this intervention are needed.

[Sleeping position to prevent sudden infant death syndrome in Latin-american and Caribbean hospitals]. / Posición al dormir en hospitales de América Latina y el Caribe para la prevención del síndrome de muerte súbita del lactante.

Background The prone sleeping position for sleeping has been identified as the principal risk factor for sudden infant death syndrome (SIDS).ObjectiveThe aim of this study was to determine the prevalence of different sleeping positions and other risk factors for SIDS and to identify the advice given to parents in several maternity units in Latin America and the Caribbean through a specially-designed questionnaire.MethodsDescriptive cross-sectional study based in hospitals. All the countries in Latin America and the Caribbean were contacted through the Pan American Health Organization and responses were obtained from 16 countries.ResultsTwo hundred thirteen hospitals answered the survey. The preferred sleeping position for healthy infants was prone in 8.5 % of the hospitals, side in 48.8 %, and supine in 25.2 %. In 17.5 % of the hospitals no position was preferred or the answers were inconsistent.Concerning the recommendations given to parents on the best position for their infants at home, 25.7 % recommended the supine position, 7.6 % the prone position, 59.0 % the side position while 7.6 % made no recommendations.ConclusionsThe results of this study show that in the hospitals surveyed there is a policy of not placing healthy neonates in the prone position. However, the most frequent position was the side, which is not advisable as it increases the risk of SIDS. To reduce in the incidence of SIDS, campaigns to increase the use of the supine position should be carried out in hospitals and among the general public.

The epidemiology of syphilis in pregnancy.

This study evaluated the magnitude, risk factors and outcomes of syphilis in pregnancy in a large cohort of women in four countries participating in the World Health Organization (WHO) antenatal care trial. All women attending the first prenatal care at each selected clinic were enrolled. Screening at the first antenatal visit was routinely performed with either rapid plasma reagin or Venereal Disease Research Laboratory and confirmed by fluorescent treponemal antibody absorption. All women also had the same syphilis tests after delivery. The initial prevalence, the incidence during pregnancy and the overall prevalence of syphilis at delivery were 0.9%, 0.4% and 1.3% respectively. Risk factors for syphilis during pregnancy were younger age for the incidence and older age and a history of stillbirth for the prevalence. Women with syphilis during pregnancy had significantly more adverse outcomes. We support the recommendation that in addition to the initial testing, a second routine test for syphilis ought to be established early in the third trimester even in low prevalence areas.

WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care.

BACKGROUND: We undertook a multicentre randomised controlled trial that compared the standard model of antenatal care with a new model that emphasises actions known to be effective in improving maternal or neonatal outcomes and has fewer clinic visits. METHODS: Clinics in Argentina, Cuba, Saudi Arabia, and Thailand were randomly allocated to provide either the new model (27 clinics) or the standard model currently in use (26 clinics). All women presenting for antenatal care at these clinics over an average of 18 months were enrolled. Women enrolled in clinics offering the new model were classified on the basis of history of obstetric and clinical conditions. Those who did not require further specific assessment or treatment were offered the basic component of the new model, and those deemed at higher risk received the usual care for their conditions; however, all were included in the new-model group for the analyses, which were by intention to treat. The primary outcomes were low birthweight (<2500 g), pre-eclampsia/eclampsia, severe postpartum anaemia (<90 g/L haemoglobin), and treated urinary-tract infection. There was an assessment of quality of care and an economic evaluation. FINDINGS: Women attending clinics assigned the new model (n=12568) had a median of five visits compared with eight within the standard model (n=11958). More women in the new model than in the standard model were referred to higher levels of care (13.4% vs 7.3%), but rates of hospital admission, diagnosis, and length of stay were similar. The groups had similar rates of low birthweight (new model 7.68% vs standard model 7.14%; stratified rate difference 0.96 [95% CI -0.01 to 1.92]), postpartum anaemia (7.59% vs 8.67%; 0.32), and urinary-tract infection (5.95% vs 7.41%; -0.42 [-1.65 to 0.80]). For pre-eclampsia/eclampsia the rate was slightly higher in the new model (1.69% vs 1.38%; 0.21 [-0.25 to 0.67]). Adjustment by several confounding variables did not modify this pattern. There were negligible differences between groups for several secondary outcomes. Women and providers in both groups were, in general, satisfied with the care received, although some women assigned the new model expressed concern about the timing of visits. There was no cost increase, and in some settings the new model decreased cost. INTERPRETATIONS: Provision of routine antenatal care by the new model seems not to affect maternal and perinatal outcomes. It could be implemented without major resistance from women and providers and may reduce cost.

Methodological considerations on the design and analysis of an equivalence stratified cluster randomization trial.

The World Health Organization and collaborating institutions in four developing countries have conducted a multi-centre randomized controlled trial, in which clinics were allocated at random to two antenatal care (ANC) models. These were the standard 'Western' ANC model and a 'new' ANC model consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. The two models were compared using the equivalence approach. This paper discusses the implications of the equivalence approach in the sample size calculation, analysis and interpretation of results of this cluster randomized trial. It reviews the ethical aspects regarding informed consent, concluding that the Zelen design has a place in cluster randomization trials. It describes the estimation of the intracluster correlation coefficient (ICC) in a stratified cluster randomized trial using two methods and reports estimates of the ICC obtained for many maternal, newborn and perinatal outcomes. Finally, it discusses analytical problems that arose: issues encountered using a composite index, heterogeneity of the intervention effect across sites, the choice of the method of analysis and the importance of efficacy analyses. The choice of the clustered Woolf estimator and the generalized estimating equations (GEE) as the methods of analysis applied is discussed.

Maternal morbidity and mortality associated with interpregnancy interval: cross sectional study.

OBJECTIVE: To study the impact of interpregnancy interval on maternal morbidity and mortality. DESIGN: Retrospective cross sectional study with data from the Perinatal Information System database of the Latin American Centre for Perinatology and Human Development, Montevideo, Uruguay. SETTING: Latin America and the Caribbean, 1985-97. PARTICIPANTS: 456 889 parous women delivering singleton infants. MAIN OUTCOME MEASURES: Crude and adjusted odds ratios of the effects of short and long interpregnancy intervals on maternal death, pre-eclampsia, eclampsia, gestational diabetes mellitus, third trimester bleeding, premature rupture of membranes, postpartum haemorrhage, puerperal endometritis, and anaemia. RESULTS: Short (<6 months) and long (>59 months) interpregnancy intervals were observed for 2.8% and 19.5% of women, respectively. After adjustment for major confounding factors, compared with those conceiving at 18 to 23 months after a previous birth, women with interpregnancy intervals of 5 months or less had higher risks for maternal death (odds ratio 2.54; 95% confidence interval 1.22 to 5.38), third trimester bleeding (1.73; 1.42 to 2.24), premature rupture of membranes (1.72; 1.53 to 1.93), puerperal endometritis (1.33; 1.22 to 1.45), and anaemia (1.30; 1.18 to 1.43). Compared with women with interpregnancy intervals of 18 to 23 months, women with interpregnancy intervals longer than 59 months had significantly increased risks of pre-eclampsia (1.83; 1.72 to 1.94) and eclampsia (1.80; 1.38 to 2.32). CONCLUSIONS: Interpregnancy intervals less than 6 months and longer than 59 months are associated with an increased risk of adverse maternal outcomes.

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants.

BACKGROUND: Kangaroo mother care (KMC), defined as skin-to-skin contact between a mother and her newborn, frequent and exclusive or nearly exclusive breastfeeding, and early discharge from hospital, has been proposed as an alternative to conventional neonatal care for low birthweight (LBW) infants. OBJECTIVES: To determine whether there is evidence to support the use of KMC in LBW infants as an alternative to conventional care after the initial period of stabilization with conventional care. SEARCH STRATEGY: We used the standard search strategy of the Neonatal Review Group of the Cochrane Collaboration. MEDLINE, EMBASE, LILACS, POPLINE and CINAHL databases, and the Cochrane Controlled Trials Register (Cochrane Library) up to Issue 2, 2000, were searched using the key words terms "kangaroo mother care" or "kangaroo mother method" or "skin-to-skin contact" and "infants" or "low birthweight infants". SELECTION CRITERIA: Randomised trials comparing KMC and conventional neonatal care in LBW infants. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. Statistical analysis was conducted using the standard Cochrane Collaboration methods. MAIN RESULTS: Three studies, involving 1362 infants, were included. All the trials were conducted in developing countries. The studies were of moderate to poor methodological quality. The most common shortcomings were in the areas of blinding procedures for those who collected the outcomes measures, handling of drop outs, and completeness of follow-up. The great majority of results consist of results of a single trial. KMC was associated with the following reduced risks: nosocomial infection at 41 weeks' corrected gestational age (relative risk 0.49, 95% confidence interval 0.25 to 0.93), severe illness (relative risk 0.30, 95% confidence interval 0.14 to 0.67), lower respiratory tract disease at 6 months follow-up (relative risk 0.37, 95% confidence interval 0.15 to 0.89), not exclusively breastfeeding at discharge (relative risk 0.41, 95% confidence interval 0.25 to 0.68), and maternal dissatisfaction with method of care (relative risk 0.41, 95% confidence interval 0.22 to 0.75). KMC infants had gained more weight per day by discharge (weighted mean difference 3.6 g/day, 95% confidence interval 0.8 to 6.4). Scores on mother's sense of competence according to infant stay in hospital and admission to NICU were better in KMC than in control group (weighted mean differences 0.31 [95% confidence interval 0.13 to 0.50] and 0.28 [95% confidence interval 0.11 to 0.46], respectively). Scores on mother's perception of social support according to infant stay in NICU were worse in KMC group than in control group (weighted mean difference -0.18 (95% confidence interval -0.35 to -0.01). There was no evidence of a difference in infant mortality. However, serious concerns about the methodological quality of the included trials weaken credibility in these findings. REVIEWER'S CONCLUSIONS: Although KMC appears to reduce severe infant morbidity without any serious deleterious effect reported, there is still insufficient evidence to recommend its routine use in LBW infants. Well designed randomized controlled trials of this intervention are needed.