A bit of medical paternalism? A qualitative study on power relations between women and healthcare providers when deciding on mode of birth in five public maternity wards of Argentina.

BACKGROUND: Whether women should be able to decide on mode of birth in healthcare settings has been a topic of debate in the last few decades. In the context of a marked increase in global caesarean section rates, a central dilemma is whether pregnant women should be able to request this procedure without medical indication. Since 2015, Law 25,929 of Humanised Birth is in place in Argentina. This study aims at understanding the power relations between healthcare providers, pregnant women, and labour companions regarding decision-making on mode of birth in this new legal context. To do so, central concepts of power theory are used. METHODS: This study uses a qualitative design. Twenty-six semi-structured interviews with healthcare providers were conducted in five maternity wards in different regions of Argentina. Participants were purposively selected using heterogeneity sampling and included obstetrician/gynaecologists (heads of department, specialists working in 24-h shifts, and residents) and midwives where available. Reflexive thematic analysis was used to inductively develop themes and categories. RESULTS: Three themes were developed: (1) Healthcare providers reconceptualize decision-making processes of mode of birth to make women's voices matter; (2) Healthcare providers feel powerless against women's request to choose mode of birth; (3) Healthcare providers struggle to redirect women's decision regarding mode of birth. An overarching theme was built to explain the power relations between healthcare providers, women and labour companions: Healthcare providers' loss of beneficial power in decision-making on mode of birth. CONCLUSIONS: Our analysis highlights the complexity of the healthcare provider-woman interaction in a context in which women are, in practice, allowed to choose mode of birth. Even though healthcare providers claim to welcome women being an active part of the decision-making processes, they feel powerless when women make autonomous decisions regarding mode of birth. They perceive themselves to be losing beneficial power in the eyes of patients and consider fruitful communication on risks and benefits of each mode of birth to not always be possible. At the same time, providers perform an increasing number of CSs without medical indication when it is convenient for them, which suggests that paternalistic practices are still in place.

In the last few decades, there has been a debate on whether women should be able to choose if they haver a vaginal birth or a caesarean section. This debate has been framed by the fact that an increasing number of caesarean sections are being performed. Since 2015, Argentina has a Law of Humanised Birth. We conducted a study to understand the power relations between healthcare providers, pregnant women and labour companions in decision making on mode of birth in this new legal context. To do so, we used central concepts of power theory. We conducted 26 semi-structured interviews with healthcare providers in five maternity wards of Argentina. The interviewees were obstetrician/gynaecologists (heads of department, specialists working in 24-h shifts, and residents) and midwives where available. We used thematic analysis to build themes from the data. We discovered that healthcare providers perceive themselves to be losing beneficial power in decision-making on mode of birth. Even though they claim to want women to make autonomous decisions, they feel frustrated when this happens. They also perceive it to be more difficult to communicate with patients regarding the risks and benefits of vaginal birth and caesarean section. At the same time, providers carry out an increasing number of CSs without medical indication when it is convenient for them, which suggests that paternalistic practices are still in place.

Maternal characteristics and causes associated with refractory postpartum haemorrhage after vaginal birth: a secondary analysis of the WHO CHAMPION trial data.

OBJECTIVE: To assess the maternal characteristics and causes associated with refractory postpartum haemorrhage (PPH). DESIGN: Secondary analysis of the WHO CHAMPION trial data. SETTING: Twenty-three hospitals in ten countries. POPULATION: Women from the CHAMPION trial who received uterotonics as first-line treatment of PPH. METHODS: We assessed the association between sociodemographic, pregnancy and childbirth factors and refractory PPH, and compared the causes of PPH between women with refractory PPH and women responsive to first-line PPH treatment. MAIN OUTCOME MEASURES: Maternal characteristics; causes of PPH. RESULTS: Women with labour induced or augmented with uterotonics (adjusted odds ratio [aOR] 1.35; 95% CI 1.07-1.72), with episiotomy or tears requiring suturing (aOR 1.82; 95% CI 1.34-2.48) and who had babies with birthweights ≥3500 g (aOR 1.33; 95% CI 1.04-1.69) showed significantly higher odds of refractory PPH compared with the reference categories in the multivariate analysis adjusted by centre and trial arm. While atony was the sole PPH cause in 53.2% (116/218) of the women in the responsive PPH group, it accounted for only 31.5% (45/143) of the causes in the refractory PPH group. Conversely, tears were the sole cause in 12.8% (28/218) and 28% (40/143) of the responsive PPH and refractory PPH groups, respectively. Placental problems were the sole cause in 11 and 5.6% in the responsive and refractory PPH groups, respectively. CONCLUSION: Women with refractory PPH showed a different pattern of maternal characteristics and PPH causes compared with those with first-line treatment responsive PPH. TWEETABLE ABSTRACT: Women with refractory postpartum haemorrhage are different from those with first-line treatment responsive PPH.

Clinical practice patterns on the use of magnesium sulphate for treatment of pre-eclampsia and eclampsia: a multi-country survey.

OBJECTIVE: To characterise the current clinical practice patterns regarding the use of magnesium sulphate (MgSO4 ) for eclampsia prevention and treatment in a multi-country network of health facilities and compare with international recommendations. DESIGN: Cross-sectional survey. SETTING: A total of 147 health facilities in 15 countries across Africa, Latin America and Asia. POPULATION: Heads of obstetric departments or maternity units. METHODS: Anonymous online and paper-based survey conducted in 2015. MAIN OUTCOME MEASURES: Availability and use of MgSO4 ; availability of a formal clinical protocol for MgSO4 administration; and MgSO4 dosing regimens for eclampsia prevention and treatment. RESULTS: Magnesium sulphate and a formal protocol for its administration were reported to be always available in 87.4% and 86.4% of all facilities, respectively. MgSO4 was used for the treatment of mild pre-eclampsia, severe pre-eclampsia and eclampsia in 24.3%, 93.5% and 96.4% of all facilities, respectively. Regarding the treatment of severe pre-eclampsia, 26.4% and 7.0% of all facilities reported using dosing regimens that were consistent with Zuspan and Pritchard regimens, respectively. Across regions, intramuscular maintenance regimens were more commonly used in the African region (45.7%) than in the Latin American (3.0%) and Asian (22.9%) regions, whereas intravenous maintenance regimens were more often used in the Latin American (94.0%) and Asian (60.0%) regions than in the African region (21.7%). Similar patterns were found for the treatment of eclampsia across regions. CONCLUSIONS: The reported clinical use of MgSO4 for eclampsia prevention and treatment varied widely, and was largely inconsistent with current international recommendations. TWEETABLE ABSTRACT: MgSO4 regimens for eclampsia prevention and treatment in many hospitals are inconsistent with international recommendations.

Interpregnancy interval and perinatal outcomes across Latin America from 1990 to 2009: a large multi-country study.

OBJECTIVE: To determine the relationship of interpregnancy interval with maternal and offspring outcomes. DESIGN: Retrospective study with data from the Perinatal Information System database of the Latin American Centre for Perinatology and Human Development, Uruguay. SETTING: Latin America, 1990-2009. POPULATION: A cohort of 894 476 women delivering singleton infants. METHODS: During 1990-2009 the Perinatal Information System database of the Latin American Centre for Perinatology identified 894 476 women with defined interpregnancy intervals: i.e. the time elapsed between the date of the previous delivery and the first day of the last normal menstrual period for the index pregnancy. Using the interval 12-23 months as the reference category, multiple logistic regression estimated adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs) of the association between various interval lengths and maternal and offspring outcomes. MAIN OUTCOME MEASURES: Maternal death, pre-eclampsia, eclampsia, puerperal infection, fetal death, neonatal death, preterm birth, and low birthweight. RESULTS: In the reference interval there was 0.05% maternal death, 1.00% postpartum haemorrhage, 2.80% pre-eclampsia, 0.15% eclampsia, 0.28% puerperal infection, 3.45% fetal death, 0.68% neonatal death, 12.33% preterm birth, and 9.73% low birthweight. Longer intervals had increased odds of pre-eclampsia (>72 months), fetal death (>108-119 months), and low birthweight (96-107 months). Short intervals of <12 months had increased odds of pre-eclampsia (aOR 0.80; 95% CI 0.76-0.85), neonatal death (aOR 1.18; 95% CI 1.08-1.28), and preterm birth (aOR 1.16; 95% CI 1.11-1.21). Statistically, the interval had no relationship with maternal death, eclampsia, and puerperal infection. CONCLUSIONS: A short interpregnancy interval of <12 months is associated with pre-eclampsia, neonatal mortality, and preterm birth, but not with other maternal or offspring outcomes. Longer intervals of >72 months are associated with pre-eclampsia, fetal death, and low birthweight, but not with other maternal or offspring outcomes. TWEETABLE ABSTRACT: A short interpregnancy interval of <12 months is associated with neonatal mortality and preterm birth.

Clinical pharmacokinetic properties of magnesium sulphate in women with pre-eclampsia and eclampsia.

BACKGROUND: The pharmacokinetic basis of magnesium sulphate (MgSO4 ) dosing regimens for eclampsia prophylaxis and treatment is not clearly established. OBJECTIVES: To review available data on clinical pharmacokinetic properties of MgSO4 when used for women with pre-eclampsia and/or eclampsia. SEARCH STRATEGY: MEDLINE, EMBASE, CINAHL, POPLINE, Global Health Library and reference lists of eligible studies. SELECTION CRITERIA: All study types investigating pharmacokinetic properties of MgSO4 in women with pre-eclampsia and/or eclampsia. DATA COLLECTION AND ANALYSIS: Two authors extracted data on basic pharmacokinetic parameters reflecting the different aspects of absorption, bioavailability, distribution and excretion of MgSO4 according to identified dosing regimens. MAIN RESULTS: Twenty-eight studies investigating pharmacokinetic properties of 17 MgSO4 regimens met our inclusion criteria. Most women (91.5%) in the studies had pre-eclampsia. Baseline serum magnesium concentrations were consistently <1 mmol/l across studies. Intravenous loading dose between 4 and 6 g was associated with a doubling of this baseline concentration half an hour after injection. Maintenance infusion of 1 g/hour consistently produced concentrations well below 2 mmol/l, whereas maintenance infusion at 2 g/hour and the Pritchard intramuscular regimen had higher but inconsistent probability of producing concentrations between 2 and 3 mmol/l. Volume of distribution of magnesium varied (13.65-49.00 l) but the plasma clearance was fairly similar (4.28-5.00 l/hour) across populations. CONCLUSION: The profiles of Zuspan and Pritchard regimens indicate that the minimum effective serum magnesium concentration for eclampsia prophylaxis is lower than the generally accepted level. Exposure-response studies to identify effective alternative dosing regimens should target concentrations achievable by these standard regimens. TWEETABLE ABSTRACT: Minimum effective serum magnesium concentration for eclampsia prophylaxis is lower than the generally accepted therapeutic level.

A global reference for caesarean section rates (C-Model): a multicountry cross-sectional study.

OBJECTIVE: To generate a global reference for caesarean section (CS) rates at health facilities. DESIGN: Cross-sectional study. SETTING: Health facilities from 43 countries. POPULATION/SAMPLE: Thirty eight thousand three hundred and twenty-four women giving birth from 22 countries for model building and 10,045,875 women giving birth from 43 countries for model testing. METHODS: We hypothesised that mathematical models could determine the relationship between clinical-obstetric characteristics and CS. These models generated probabilities of CS that could be compared with the observed CS rates. We devised a three-step approach to generate the global benchmark of CS rates at health facilities: creation of a multi-country reference population, building mathematical models, and testing these models. MAIN OUTCOME MEASURES: Area under the ROC curves, diagnostic odds ratio, expected CS rate, observed CS rate. RESULTS: According to the different versions of the model, areas under the ROC curves suggested a good discriminatory capacity of C-Model, with summary estimates ranging from 0.832 to 0.844. The C-Model was able to generate expected CS rates adjusted for the case-mix of the obstetric population. We have also prepared an e-calculator to facilitate use of C-Model (www.who.int/reproductivehealth/publications/maternal_perinatal_health/c-model/en/). CONCLUSIONS: This article describes the development of a global reference for CS rates. Based on maternal characteristics, this tool was able to generate an individualised expected CS rate for health facilities or groups of health facilities. With C-Model, obstetric teams, health system managers, health facilities, health insurance companies, and governments can produce a customised reference CS rate for assessing use (and overuse) of CS. TWEETABLE ABSTRACT: The C-Model provides a customized benchmark for caesarean section rates in health facilities and systems.

Pre-eclampsia, eclampsia and adverse maternal and perinatal outcomes: a secondary analysis of the World Health Organization Multicountry Survey on Maternal and Newborn Health.

OBJECTIVE: To assess the incidence of hypertensive disorders of pregnancy and related severe complications, identify other associated factors and compare maternal and perinatal outcomes in women with and without these conditions. DESIGN: Secondary analysis of the World Health Organization Multicountry Survey on Maternal and Newborn Health (WHOMCS) database. SETTING: Cross-sectional study implemented at 357 health facilities conducting 1000 or more deliveries annually in 29 countries from Africa, Asia, Latin America and the Middle East. POPULATION: All women suffering from any hypertensive disorder during pregnancy, the intrapartum or early postpartum period in the participating hospitals during the study period. METHODS: We calculated the proportion of the pre-specified outcomes in the study population and their distribution according to hypertensive disorders' severity. We estimated the association between them and maternal deaths, near-miss cases, and severe maternal complications using a multilevel logit model. MAIN OUTCOME MEASURES: Hypertensive disorders of pregnancy. Potentially life-threatening conditions among maternal near-miss cases, maternal deaths and cases without severe maternal outcomes. RESULTS: Overall, 8542 (2.73%) women suffered from hypertensive disorders. Incidences of pre-eclampsia, eclampsia and chronic hypertension were 2.16%, 0.28% and 0.29%, respectively. Maternal near-miss cases were eight times more frequent in women with pre-eclampsia, and increased to up to 60 times more frequent in women with eclampsia, when compared with women without these conditions. CONCLUSIONS: The analysis of this large database provides estimates of the global distribution of the incidence of hypertensive disorders of pregnancy. The information on the most frequent complications related to pre-eclampsia and eclampsia could be of interest to inform policies for health systems organisation.

Caesarean section without medical indications is associated with an increased risk of adverse short-term maternal outcomes: the 2004-2008 WHO Global Survey on Maternal and Perinatal Health.

BACKGROUND: There is worldwide debate about the appropriateness of caesarean sections performed without medical indications. In this analysis, we aim to further investigate the relationship between caesarean section without medical indication and severe maternal outcomes. METHODS: This is a multicountry, facility-based survey that used a stratified multistage cluster sampling design to obtain a sample of countries and health institutions worldwide. A total of 24 countries and 373 health facilities participated in this study. Data collection took place during 2004 and 2005 in Africa and the Americas and during 2007 and 2008 in Asia. All women giving birth at the facility during the study period were included and had their medical records reviewed before discharge from the hospital. Univariate and multilevel analysis were performed to study the association between each group's mode of delivery and the severe maternal and perinatal outcome. RESULTS: A total of 286,565 deliveries were analysed. The overall caesarean section rate was 25.7% and a total of 1.0 percent of all deliveries were caesarean sections without medical indications, either due to maternal request or in the absence of other recorded indications. Compared to spontaneous vaginal delivery, all other modes of delivery presented an association with the increased risk of death, admission to ICU, blood transfusion and hysterectomy, including antepartum caesarean section without medical indications (Adjusted Odds Ratio (Adj OR), 5.93, 95% Confidence Interval (95% CI), 3.88 to 9.05) and intrapartum caesarean section without medical indications (Adj OR, 14.29, 95% CI, 10.91 to 18.72). In addition, this association is stronger in Africa, compared to Asia and Latin America. CONCLUSIONS: Caesarean sections were associated with an intrinsic risk of increased severe maternal outcomes. We conclude that caesarean sections should be performed when a clear benefit is anticipated, a benefit that might compensate for the higher costs and additional risks associated with this operation.

Factors and outcomes associated with the induction of labour in Latin America.

OBJECTIVE: To describe the prevalence of labour induction, together with its risk factors and outcomes in Latin America. DESIGN: Analysis of the 2005 WHO global survey database. SETTING: Eight selected Latin American countries. POPULATION: All women who gave birth during the study period in 120 participating institutions. METHODS: Bivariate and multivariate analyses. MAIN OUTCOME MEASURES: Indications for labour induction per country, success rate per method, risk factors for induction, and maternal and perinatal outcomes. RESULTS: Of the 97,095 deliveries included in the survey, 11,077 (11.4%) were induced, with 74.2% occurring in public institutions, 20.9% in social security hospitals and 4.9% in private institutions. Induction rates ranged from 5.1% in Peru to 20.1% in Cuba. The main indications were premature rupture of membranes (25.3%) and elective induction (28.9%). The success rate of vaginal delivery was very similar for oxytocin (69.9%) and misoprostol (74.8%), with an overall success rate of 70.4%. Induced labour was more common in women over 35 years of age. Maternal complications included higher rates of perineal laceration, need for uterotonic agents, hysterectomy, ICU admission, hospital stay>7 days and increased need for anaesthetic/analgesic procedures. Some adverse perinatal outcomes were also higher: low 5-minute Apgar score, very low birthweight, admission to neonatal ICU and delayed initiation of breastfeeding. CONCLUSIONS: In Latin America, labour was induced in slightly more than 10% of deliveries; success rates were high irrespective of the method used. Induced labour is, however, associated with poorer maternal and perinatal outcomes than spontaneous labour.

Bed rest with or without hospitalisation for hypertension during pregnancy.

BACKGROUND: Bed rest or restriction of activity, with or without hospitalisation, have been advocated for women with hypertension during pregnancy to improve pregnancy outcome. However, benefits need to be demonstrated before such interventions can be recommended since restricted activity may be disruptive to women's lives, expensive, and increase the risk of thromboembolism. OBJECTIVES: To assess the effects on the mother and the baby of different degrees of bed rest, compared with each other, and with routine activity, in hospital or at home, for primary treatment of hypertension during pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (April 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2005), and EMBASE (January 2002 to December 2004). SELECTION CRITERIA: Randomised trials evaluating bed rest for women with hypertension in pregnancy were selected. DATA COLLECTION AND ANALYSIS: Two review authors assessed trials for inclusion independently, and extracted data. Data were entered into RevMan software and double-checked. MAIN RESULTS: Four small trials (449 women) were included. Three were of good quality. Two trials (145 women) compared strict bed rest with some rest, in hospital, for women with proteinuric hypertension. There was insufficient evidence to demonstrate any differences between the groups for reported outcomes. Two trials (304 women) compared some bed rest in hospital with routine activity at home for non-proteinuric hypertension. There was reduced risk of severe hypertension (1 trial, 218 women; RR 0.58, 95% CI 0.38 to 0.89) and a borderline reduction in risk of preterm birth (1 trial, 218 women; RR 0.53, CI 0.29 to 0.99) with some rest compared to normal activity. More women in the bed rest group opted not to have the same management in future pregnancies, if the choice were given (1 trial, 86 women; RR 3.00, 95% CI 1.43 to 6.31). There were no significant differences for any other outcomes. AUTHORS' CONCLUSIONS: Few randomised trials have evaluated rest for women with hypertension during pregnancy, and important information on side-effects and cost implication is missing from available trials. Although one small trial suggests that some bed rest may be associated with reduced risk of severe hypertension and preterm birth, these findings need to be confirmed in larger trials. At present, there is insufficient evidence to provide clear guidance for clinical practice. Therefore, bed rest should not be recommended routinely for hypertension in pregnancy, especially since more women appear to prefer unrestricted activity, if the choice were given.

Community-based supplementary feeding for promoting the growth of young children in developing countries.

BACKGROUND: Supplementary feeding is defined as the provision of extra food to poor children or families beyond the normal ration of their home diets. The impact of food supplementation on child growth merits careful evaluation in view of the reliance of many states and NGOs on this intervention to improve child health in developing countries. OBJECTIVES: To evaluate the effectiveness of community-based supplementary feeding for promoting the physical growth of pre-school children in developing countries. SEARCH STRATEGY: Searches of CENTRAL 2005 (Issue 2), MEDLINE 1966 to 2005, EMBASE 1980 to 2005, CINAHL 1982 to 2005, LILACS 1982 to 2005, Social Science Citation Index 1956 to 2005, and Dissertation Abstracts International (late 1960s to 2005) were conducted. SELECTION CRITERIA: Randomised controlled trials evaluating supplementary feeding in children aged 0-5 years old in developing countries. DATA COLLECTION AND ANALYSIS: Data were extracted and analysed independently by two authors. MAIN RESULTS: Four trials met the inclusion criteria for this review. No meta-analysis is currently appropriate due to the clinical heterogeneity among the included studies. We group these trials into two categories: a) studies without formally assessment of malnourishment at baseline and, b) studies involving children formally assessed as malnourished.a) A cluster RCT conducted in Indonesia in 1991(20 Day Care Centres, n = 113 children), found no benefit in weight-for-age and height-for-age z-scores of the intervention group compared to the control group after three months of intervention. A study in Guatemala included four villages as unit of analysis (exact sample sizes were not provided). The length of 3-yr-old children was based on a 'before-after comparison' by village size and type of supplement. According to this analysis, the difference in net change in the large villages was 2.55 cm and in the small villages was 2.35 cm. The mean of these differences is 2.45 +- 0.10 cm (mean +- SD).b) A study conducted in Jamaica (n = 65 children) reported a positive effect on length (cm) in the supplemented group compared to controls [WMD 1.3 (0.03 to 2.57)] after 12 months of intervention. A trial from Indonesia (n = 75 children) found no benefit in growth after 12 months of supplementation. AUTHORS' CONCLUSIONS: Based on the small number of available trials, no firm conclusions of the effectiveness of supplementary feeding to the growth of pre-school children could be drawn. Issues of research design such as blinding and sample size calculation need to be addressed in future studies.

Rubella and measles seroprevalence among women of childbearing age, Argentina, 2002.

To assess rubella and measles susceptibility among women of childbearing age we conducted a cross-sectional seroprevalence study in four cities and one rural area in Argentina. A convenience sample of women aged 15-49 years seeking care in public health-care institutions was selected (n=2804). Serum specimens were tested for rubella and measles IgG antibody titres. The overall susceptibility to rubella and measles was 8.8 and 12.5% respectively. Seroprevalence differences were found for both rubella (P<0.001) and measles (P=0.002) across sites. Rubella seroprevalence was higher in women aged >or=40 years than in younger women (P=0.04). Measles seroprevalence tended to increase with age (P<0.001). Approximately 15% of women aged 15-29 years were not immune to measles. No risk factors were associated with rubella seronegativity; however, age (P<0.001) and having less than four pregnancies (P<0.001) were factors associated with measles seronegativity. Our findings support the introduction of supplemental immunization activities targeting adolescents and young adults to prevent congenital rubella syndrome and measles outbreaks over time.

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.

Ambulatory versus conventional methods for monitoring blood pressure during pregnancy.

BACKGROUND: Hypertensive disorders are among the most common medical complications of pregnancy and a leading cause of maternal and perinatal morbidity and mortality world-wide. Blood pressure measurement plays a central role in the screening and management of hypertension during pregnancy. In recent years the validity of conventional (clinic) blood pressure measurement has been questioned and efforts have been made to improve the technique with ambulatory automated devices that provide a large number of measurements over a period of time, usually a 24-hour period. OBJECTIVES: To assess whether the use of ambulatory blood pressure monitoring during pregnancy improves subsequent maternal and feto-neonatal outcomes, women-newborn quality of life or use of health service resources, compared with conventional (clinic) blood pressure measurements. These effects will be assessed for the following subgroups: (1) Women at low or average risk of hypertensive disorders of pregnancy (unselected). (2) Women defined as high risk of hypertensive disorders of pregnancy. (3) Women with hypertension without other signs of pre-eclampsia. (4) Women with established pre-eclampsia. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register, MEDLINE, LILACS and EMBASE were searched. Date of last search: July 2001. SELECTION CRITERIA: All randomised trials comparing ambulatory blood pressure monitoring versus conventional (clinic) blood pressure monitoring in pregnancy. Quasi-random designs will be excluded. DATA COLLECTION AND ANALYSIS: Two reviewers evaluated all potentially relevant articles, examined each study for possible inclusion and assessed the methodological quality using the Cochrane guidelines. MAIN RESULTS: No trials included. REVIEWER'S CONCLUSIONS: There is no randomised controlled trial evidence to support the use of ambulatory blood pressure monitoring during pregnancy. Randomized trials with adequate design and sample sizes are needed to evaluate the possible advantages and risks of ambulatory blood pressure monitoring during pregnancy, in particular in hypertensive pregnant women. These trials should evaluate not only clinical outcomes, but also use of health care resources and women's views.

The gap between evidence and practice in maternal healthcare.

The expected improvement in maternal and perinatal health in developing countries has not yet materialized. In addition to the factors related to socioeconomic conditions, we have identified areas where large gaps between evidence and practice are apparent. These gaps are in clinical care, implementation of effective practices and in selecting research priorities. We present examples from our own research and the literature to illustrate these points.

Meta-analyses in systematic reviews of randomized controlled trials in perinatal medicine: comparison of fixed and random effects models.

There is a need for empirical work comparing the random effects model with the fixed effects model in the calculation of a pooled relative risk in the meta-analysis in systematic reviews of randomized controlled trials. Such comparisons are particularly important when trial results are heterogeneous. We considered 84 independent meta-analyses in which each trial included a set of different women/newborns. These meta-analyses were included in systematic reviews published in the Cochrane Library's pregnancy and childbirth module. Twenty-one of these 84 meta-analyses demonstrated statistical heterogeneity at p<0.10. The random effects model estimates showed wider confidence intervals, particularly in those meta-analyses showing heterogeneity in the trial results. The summary relative risk for the random effects model tended to show a larger protective treatment effect than the fixed effects model in the heterogeneous meta-analyses. In this set of meta-analyses, statistical evaluation of publication bias cannot be shown to account for heterogeneity. Our empirical conclusion is that there may be opposing effects if the random effects model is used in the meta-analysis of clinical trials showing heterogeneity in the results: stronger treatment effects reflected in the summary relative risk, but wider confidence intervals about this summary measure.

Patterns of routine antenatal care for low-risk pregnancy.

BACKGROUND: It has been suggested that reduced antenatal care packages or prenatal care managed by providers other than obstetricians for low risk women can be as effective as standard models of antenatal care. OBJECTIVES: The objective of this review was to assess the effects of antenatal care programmes for low-risk women. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, reference lists of articles and we also contacted researchers in the field. Date of last search: May 2001 SELECTION CRITERIA: Randomised trials comparing programmes of antenatal care with varied frequency and timing of the visits and different types of care providers. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted by two reviewers independently. Study authors were contacted for additional information and they were provided with the final version of the review. MAIN RESULTS: Ten trials involving over 60,000 women were included. Seven trials evaluated the number of antenatal clinic visits, and three trials evaluated the type of care provider. Most trials were of acceptable quality. A reduction in the number of antenatal visits was not associated with an increase in any of the negative maternal and perinatal outcomes reviewed. However, trials from developed countries suggest that women can be less satisfied with the reduced number of visits and feel that their expectations with care are not fulfilled. Antenatal care provided by a midwife/general practitioner was associated with improved perception of care by women. Clinical effectiveness of midwife/general practitioner managed care was similar to that of obstetrician/gynaecologist led shared care. REVIEWER'S CONCLUSIONS: A reduction in the number of antenatal care visits with or without an increased emphasis on the content of the visits could be implemented without any increase in adverse biological maternal and perinatal outcomes. Women can be less satisfied with reduced visits. Lower costs for the mothers and providers could be achieved. While clinical effectiveness seemed similar, women appeared to be slightly more satisfied with midwife/general practitioner managed care compared with obstetrician/gynaecologist led shared care.

Umbilical vein injection for management of retained placenta.

BACKGROUND: If a retained placenta is left untreated, there is a high risk of maternal death. However, manual removal of the placenta is an invasive procedure with its own serious complications of haemorrhage, infection or genital tract trauma. OBJECTIVES: The objective of this review was to assess the use of umbilical vein injection of saline solution alone or with oxytocin in comparison either with expectant management or with an alternative solution or other uterotonic agent for retained placenta. The main comparisons include the following agents: saline solution alone, saline solution plus oxytocin, saline solution plus prostaglandin and plasma expander. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register (latest search 20 March 2001). SELECTION CRITERIA: Randomised trials comparing umbilical vein injection of saline or other fluids, with or without oxytocics, either with expectant management or with an alternative solution or other uterotonic agent, in the management of retained placenta. DATA COLLECTION AND ANALYSIS: The two reviewers assessed trial quality and extracted data. MAIN RESULTS: Twelve trials were included. The trials were of variable quality. Compared with expectant management, umbilical vein injection of saline solution alone did not show any significant difference in the incidence of manual removal of the placenta (relative risk (RR): 0.97; 95% confidence interval (CI): 0.83 to 1.14). Umbilical vein injection of saline solution plus oxytocin compared with expectant management showed a reduction in manual removal, although this was not statistically significant (RR: 0.86; 95% CI: 0.72 to 1.01). Saline solution with oxytocin compared with saline solution alone showed a significant reduction in manual removal of the placenta (RR: 0.79; 95% CI: 0.69 to 0.91) (number needed to treat: 8; 95% CI: 5 to 20). No discernible difference was detected in length of third stage of labour, blood loss, haemorrhage, haemoglobin, blood transfusion, curettage, infection, hospital stay, fever, abdominal pain and oxytocin augmentation. Umbilical vein injection of saline solution plus oxytocin compared with umbilical vein injection of plasma expander showed higher, but not statistically significant, incidence of manual removal of placenta (RR: 1.34; 95% CI: 0.97 to 1.85) and no difference in blood loss but there is only one small trial contributing to this comparison. Saline solution plus prostaglandin, compared with saline solution alone, was associated with a statistically significant lower incidence in manual removal of placenta (RR: 0.05; 95% CI: 0.00 to 0.73 ) but no difference was observed in blood loss, fever, abdominal pain, and oxytocin augmentation but there is only one small trial contributing to these results. There were no significant differences between saline solution plus prostaglandin and saline solution plus oxytocin (RR: 0.10; 95% CI: 0.01 to 1.59) but again there is only one small trial contributing to this meta-analysis. REVIEWER'S CONCLUSIONS: Umbilical vein injection of saline solution plus oxytocin appears to be effective in the management of retained placenta. Saline solution alone does not appear be more effective than expectant management. Further research into umbilical vein injection of oxytocin, prostaglandins or plasma expander is warranted.

Prophylactic use of oxytocin in the third stage of labour.

BACKGROUND: Many maternal deaths across the world result from complications of the third stage of labour (when the placenta is delivered). OBJECTIVES: To examine the effect of oxytocin given prophylactically in the third stage of labour on maternal and neonatal outcomes. SEARCH STRATEGY: Relevant trials were identified in the Cochrane Collaboration Controlled Trials Register and the Pregnancy and Childbirth Review Group's Specialised Register of Controlled Trials. Date of last search: May 2001. SELECTION CRITERIA: All acceptably randomised or quasi-randomised controlled trials including pregnant women anticipating a vaginal delivery where oxytocin was given prophylactically for the third stage of labour. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for relevance and methodological quality, and extracted data. Analysis was by intention to treat. Subgroup analyses were based on extent of selection bias, oxytocin in the context of active or expectant management of the third stage, and timing of administration. Results are presented as relative risks, and weighted mean difference, both with 95% confidence intervals using a fixed effects model. MAIN RESULTS: In seven trials involving over 3000 women in hospital and/or developed country settings, prophylactic oxytocin showed benefits (reduced blood loss (relative risk (RR) for blood loss > 500 ml 0.50; 95% confidence interval (CI) 0.43, 0.59) and need for therapeutic oxytocics (RR 0.50; 95% CI 0.39, 0.64).) compared to no uterotonics, although there was a non-significant trend towards more manual removal of the placenta (RR 1.17; 95% CI 0.79, 1.73) which was most marked in the expectant management subgroup, and blood transfusions (RR 1.30; 95% CI 0.50, 3.39) in the trials with more manual removals of the placenta). In six trials involving over 2800 women, there was little evidence of differential effects for oxytocin versus ergot alkaloids, except ergot alkaloids are associated with more manual removals of the placenta (RR 0.57; 95% CI 0.41, 0.79), and with the suggestion of more raised blood pressure (RR 0.53; 95% CI 0.19, 1.58) than with oxytocin. In five trials involving over 2800 women, there was little evidence of a synergistic effects of adding oxytocin to ergometrine versus ergometrine alone. For all other outcomes in the comparisons either there are no data or the number of adverse events is very small, and so definite conclusions cannot be drawn. REVIEWER'S CONCLUSIONS: There are strong suggestions of benefit for oxytocin in terms of postpartum haemorrhage, and the need for therapeutic oxytocics, but without sufficient information about other outcomes and side-effects it is difficult to be confident about the trade-offs for these benefits, especially if the risk of manual removal of the placenta may be increased. There seems little evidence in favour of ergot alkaloids alone compared to either oxytocin alone, or to Syntometrine, but the data are sparse. More trials are needed in domiciliary deliveries in developing countries, which shoulder most of the burden of third stage complications.

WHO multicentre randomised trial of misoprostol in the management of the third stage of labour.

BACKGROUND: Postpartum haemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labour, including use of a uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin E1 analogue) has been suggested for this purpose because it has strong uterotonic effects, can be given orally, is inexpensive, and does not need refrigeration for storage. We did a multicentre, double-blind, randomised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour. METHODS: In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, we randomly assigned women about to deliver vaginally to receive 600 microg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly, according to routine practice, plus corresponding identical placebos. The medications were administered immediately after delivery as part of the active management of the third stage of labour. The primary outcomes were measured postpartum blood loss of 1000 mL or more, and the use of additional uterotonics without an unacceptable level of side-effects. We chose an upper limit of a 35% increase in the risk of blood loss of 1000 mL or more as the margin of clinical equivalence, which was assessed by the confidence interval of the relative risk. Analysis was by intention to treat. FINDINGS: 9264 women were assigned misoprostol and 9266 oxytocin. 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded. 366 (4%) of women on misoprostol had a measured blood loss of 1000 mL or more, compared with 263 (3%) of those on oxytocin (relative risk 1.39 [95% CI 1.19-1.63], p<0.0001). 1398 (15%) women in the misoprostol group and 1002 (11%) in the oxytocin group required additional uterotonics (1.40 [1.29-1.51], p<0.0001). Misoprostol use was also associated with a significantly higher incidence of shivering (3.48 [3.15-3.84]) and raised body temperature (7.17 [5.67-9.07]) in the first hour after delivery. INTERPRETATION: 10 IU oxytocin (intravenous or intramuscular) is preferable to 600 microg oral misoprostol in the active management of the third stage of labour in hospital settings where active management is the norm.