Mariana Widmer

World Health Organization WHO, Genève, Geneva, Switzerland

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Publications (39)324.45 Total impact

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    ABSTRACT: Maternal mortality remains a daunting problem in Mozambique and many other low-resource countries. High quality antenatal care (ANC) services can improve maternal and newborn health outcomes and increase the likelihood that women will seek skilled delivery care. This study explores the factors influencing provider uptake of the recommended package of ANC interventions in Mozambique. This study used qualitative research methods including key informant interviews with stakeholders from the health sector and a total of five focus group discussions with women with experience with ANC or women from the community. Study participants were selected from three health centers located in Maputo city, Tete, and Cabo Delgado provinces in Mozambique. Staff responsible for the medicines/supply chain at national, provincial and district level were interviewed. A check list was implemented to confirm the availability of the supplies required for ANC. Deductive content analysis was conducted. Three main groups of factors were identified that hinder the implementation of the ANC package in the study setting: a) system or organizational: include chronic supply chain deficiencies, failures in the continuing education system, lack of regular audits and supervision, absence of an efficient patient record system and poor environmental conditions at the health center; b) health care provider factors: such as limited awareness of current clinical guidelines and a resistant attitude to adopting new recommendations; and c) Users: challenges with accessing ANC, poor recognition amongst women about the purpose and importance of the specific interventions provided through ANC, and widespread perception of an unfriendly environment at the health center. The ANC package in Mozambique is not being fully implemented in the three study facilities, and a major barrier is poor functioning of the supply chain system. Recommendations for improving the implementation of antenatal interventions include ensuring clinical protocols based on the ANC model. Increasing the community understanding of the importance of ANC would improve demand for high quality ANC services. The supply chain functioning could be strengthened through the introduction of a kit system with all the necessary supplies for ANC and a simple monitoring system to track the stock levels is recommended.
    Full-text · Article · Dec 2015 · BMC Pregnancy and Childbirth

  • No preview · Article · Nov 2015 · The Lancet
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    ABSTRACT: Objective: To assess the accuracy of angiogenic biomarkers to predict pre-eclampsia. Design: Prospective multicentre study. From 2006 to 2009, 5121 pregnant women with risk factors for pre-eclampsia (nulliparity, diabetes, previous pre-eclampsia, chronic hypertension) from Argentina, Colombia, Peru, India, Italy, Kenya, Switzerland and Thailand had their serum tested for sFlt-1, PlGF and sEng levels and their urine for PlGF levels at ≤20, 23-27 and 32-35. weeks' gestation (index tests, results blinded from carers). Women were monitored for signs of pre-eclampsia, diagnosed by systolic blood pressure ≥140. mmHg and/or diastolic blood pressure ≥90. mmHg, and proteinuria (protein/creatinine ratio ≥0.3, protein ≥1. g/l, or one dipstick measurement ≥2+) appearing after 20. weeks' gestation. Early pre-eclampsia was defined when these signs appeared ≤34. weeks' gestation. Main outcome measure: Pre-eclampsia. Results: Pre-eclampsia was diagnosed in 198 of 5121 women tested (3.9%) of whom 47 (0.9%) developed it early. The median maternal serum concentrations of index tests were significantly altered in women who subsequently developed pre-eclampsia than in those who did not. However, the area under receiver operating characteristics curve at ≤20. weeks' gestation were closer to 0.5 than to 1.0 for all biomarkers both for predicting any pre-eclampsia or at ≤34. weeks' gestation. The corresponding sensitivity, specificity and likelihood ratios were poor. Multivariable models combining sEng with clinical features slightly improved the prediction capability. Conclusions: Angiogenic biomarkers in first half of pregnancy do not perform well enough in predicting the later development of pre-eclampsia.
    Full-text · Article · Sep 2015 · Pregnancy Hypertension
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    ABSTRACT: Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula. In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fistula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fistula. A research assistant at each site randomly allocated participants 1:1 (randomly varying block sizes of 4-6; stratified by country) to 7 day or 14 day bladder catheterisation (via a random allocation sequence computer generated centrally by WHO). Outcome assessors were not masked to treatment assignment. The primary outcome was fistula repair breakdown, on the basis of dye test results, any time between 8 days after catheter removal and 3 months after surgery. The non-inferiority margin was 10%, assessed in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT01428830. We randomly allocated 524 participants between March 7, 2012, and May 6, 2013; 261 in the 7 day group and 263 in the 14 day group. In the per-protocol analysis, ten (4%) of 250 patients had repair breakdown in the 7 day group (95% CI 2-8) compared with eight (3%) of 251 (2-6) in the 14 day group (risk difference 0·8% [95% CI -2·8 to 4·5]), meeting the criteria for non-inferiority. 7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown, urinary retention, or residual incontinence up to 3 months after surgery. US Agency for International Development. Copyright © 2015 Elsevier Ltd. All rights reserved.
    No preview · Article · Apr 2015 · The Lancet
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    Full-text · Article · Mar 2015 · Obstetric Anesthesia Digest
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    ABSTRACT: Assess the accuracy of serum soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF) and soluble endoglin (sEng) and urinary PlGF as predictors of preeclampsia in a prospective multicountry study. From 2006-9, 5121 pregnant women from centers in Argentina, Colombia, India, Italy, Kenya, Peru, Switzerland and Thailand had their serum tested for sFlt-1, PlGF and sEng levels and their urine for PlGF levels at ⩽20 (index tests, results kept blind from care givers), 23-27 and 32-35weeks' gestation. During prenatal care, women were closely monitored for signs of preeclampsia, diagnosed by systolic blood pressure ⩾140mmHg and/or diastolic blood pressure ⩾90mmHg, and proteinuria with protein/creatinine ratio ⩾0.3, protein ⩾1g/l or, one dipstick measurement ⩾2+ appearing after gestational week 20, and defined as early preeclampsia when these signs appeared before 34 weeks' gestation. Preeclampsia was diagnosed in 3.9% (198 of the 5121 women) whom 47 (0.9%) had early disease. No test performed well at <20 weeks for either early or all preeclampsia (area under receiver operating characteristics curve, AUC ⩽0.6). Multivariable models combining biomarkers with clinical features (age, body mass index, smoking, multiple pregnancy, hypertension or treatment for it) did not improve the prediction capability before 20weeks. Serum PlGF was the best predictor of preeclampsia at any gestation (AUC 0.82 at 32-35weeks) and at early onset (AUC 0.82 at 23-27weeks). Angiogenic biomarkers, alone or combined with clinical risk factors, performed poorly as predictors of preeclampsia, when measured early in pregnancy (<20weeks). M. Widmer: None. C.B. Cuesta: None. K. Khan: None. A.M. Gülmezoglu: None. S.A. Karumanchi: Consultant: Roche, Beckman, Siemens. M.D. Lindheimer: None. Copyright © 2014.
    No preview · Article · Jan 2015
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    ABSTRACT: Maternal mortality has declined by nearly half since 1990, but over a quarter million women still die every year of causes related to pregnancy and childbirth. Maternal-health related targets are falling short of the 2015 Millennium Development Goals and a post-2015 Development Agenda is emerging. In connection with this, setting global research priorities for the next decade is now required. We adapted the methods of the Child Health and Nutrition Research Initiative (CHNRI) to identify and set global research priorities for maternal and perinatal health for the period 2015 to 2025. Priority research questions were received from various international stakeholders constituting a large reference group, and consolidated into a final list of research questions by a technical working group. Questions on this list were then scored by the reference working group according to five independent and equally weighted criteria. Normalized research priority scores (NRPS) were calculated, and research priority questions were ranked accordingly. A list of 190 priority research questions for improving maternal and perinatal health was scored by 140 stakeholders. Most priority research questions (89%) were concerned with the evaluation of implementation and delivery of existing interventions, with research subthemes frequently concerned with training and/or awareness interventions (11%), and access to interventions and/or services (14%). Twenty-one questions (11%) involved the discovery of new interventions or technologies. Key research priorities in maternal and perinatal health were identified. The resulting ranked list of research questions provides a valuable resource for health research investors, researchers and other stakeholders. We are hopeful that this exercise will inform the post-2015 Development Agenda and assist donors, research-policy decision makers and researchers to invest in research that will ultimately make the most significant difference in the lives of mothers and babies.
    Full-text · Article · Aug 2014 · Reproductive Health
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    ABSTRACT: Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher. WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions. There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country’s health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ‘habits’ will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain management is a major challenge for many low-resource countries, we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings, will be drawn from this study. Trial registration Pan African Clinical Trial Registry database. Identification number: PACTR201306000550192.
    Full-text · Article · May 2014 · BMC Health Services Research
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    ABSTRACT: Background In 2006 WHO presented the infant and child growth charts suggested for universal application. However, major determinants for perinatal outcomes and postnatal growth are laid down during antenatal development. Accordingly, monitoring fetal growth in utero by ultrasonography is important both for clinical and scientific reasons. The currently used fetal growth references are derived mainly from North American and European population and may be inappropriate for international use, given possible variances in the growth rates of fetuses from different ethnic population groups. WHO has, therefore, made it a high priority to establish charts of optimal fetal growth that can be recommended worldwide. Methods This is a multi-national study for the development of fetal growth standards for international application by assessing fetal growth in populations of different ethnic and geographic backgrounds. The study will select pregnant women of high-middle socioeconomic status with no obvious environmental constraints on growth (adequate nutritional status, non-smoking), and normal pregnancy history with no complications likely to affect fetal growth. The study will be conducted in centres from ten developing and industrialized countries: Argentina, Brazil, Democratic Republic of Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand. At each centre, 140 pregnant women will be recruited between 8 + 0 and 12 + 6 weeks of gestation. Subsequently, visits for fetal biometry will be scheduled at 14, 18, 24, 28, 32, 36, and 40 weeks (+/− 1 week) to be performed by trained ultrasonographers. The main outcome of the proposed study will be the development of fetal growth standards (either global or population specific) for international applications. Discussion The data from this study will be incorporated into obstetric practice and national health policies at country level in coordination with the activities presently conducted by WHO to implement the use of the Child Growth Standards.
    Full-text · Article · May 2014 · BMC Pregnancy and Childbirth
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    Full-text · Article · Mar 2014 · BJOG An International Journal of Obstetrics & Gynaecology
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    E Abalos · C Cuesta · G Carroli · Z Qureshi · M Widmer · Jp Vogel · Jp Souza
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    ABSTRACT: 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. Secondary analysis of the World Health Organization Multicountry Survey on Maternal and Newborn Health (WHOMCS) database. 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. All women suffering from any hypertensive disorder during pregnancy, the intrapartum or early postpartum period in the participating hospitals during the study period. 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. Hypertensive disorders of pregnancy. Potentially life-threatening conditions among maternal near-miss cases, maternal deaths and cases without severe maternal outcomes. 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. 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.
    Full-text · Article · Mar 2014 · BJOG An International Journal of Obstetrics & Gynaecology
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    ABSTRACT: Background: Pre-eclampsia/eclampsia are leading causes of maternal mortality and morbidity, particularly in low- and middle- income countries (LMICs). We developed the miniPIERS risk prediction model to provide a simple, evidence-based tool to identify pregnant women in LMICs at increased risk of death or major hypertensive-related complications. Methods and findings: From 1 July 2008 to 31 March 2012, in five LMICs, data were collected prospectively on 2,081 women with any hypertensive disorder of pregnancy admitted to a participating centre. Candidate predictors collected within 24 hours of admission were entered into a step-wise backward elimination logistic regression model to predict a composite adverse maternal outcome within 48 hours of admission. Model internal validation was accomplished by bootstrapping and external validation was completed using data from 1,300 women in the Pre-eclampsia Integrated Estimate of RiSk (fullPIERS) dataset. Predictive performance was assessed for calibration, discrimination, and stratification capacity. The final miniPIERS model included: parity (nulliparous versus multiparous); gestational age on admission; headache/visual disturbances; chest pain/dyspnoea; vaginal bleeding with abdominal pain; systolic blood pressure; and dipstick proteinuria. The miniPIERS model was well-calibrated and had an area under the receiver operating characteristic curve (AUC ROC) of 0.768 (95% CI 0.735-0.801) with an average optimism of 0.037. External validation AUC ROC was 0.713 (95% CI 0.658-0.768). A predicted probability ≥25% to define a positive test classified women with 85.5% accuracy. Limitations of this study include the composite outcome and the broad inclusion criteria of any hypertensive disorder of pregnancy. This broad approach was used to optimize model generalizability. Conclusions: The miniPIERS model shows reasonable ability to identify women at increased risk of adverse maternal outcomes associated with the hypertensive disorders of pregnancy. It could be used in LMICs to identify women who would benefit most from interventions such as magnesium sulphate, antihypertensives, or transportation to a higher level of care.
    Full-text · Dataset · Jan 2014
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    ABSTRACT: Twin pregnancies in low- and middle-income countries (LMICs) pose a high risk to mothers and newborns due to inherent biological risks and scarcity of health resources. We conducted a secondary analysis of the WHO Global Survey dataset to analyze maternal and perinatal outcomes in twin pregnancies and factors associated with perinatal morbidity and mortality in twins. We examined maternal and neonatal characteristics in twin deliveries in 23 LMICs and conducted multi-level logistic regression to determine the association between twins and adverse maternal and perinatal outcomes. 279,425 mothers gave birth to 276,187 (98.8%) singletons and 6,476 (1.2%) twins. Odds of severe adverse maternal outcomes (death, blood transfusion, ICU admission or hysterectomy) (AOR 1.85, 95% CI 1.60-2.14) and perinatal mortality (AOR 2.46, 95% CI 1.40-4.35) in twin pregnancies were higher, however early neonatal death (AOR 2.50, 95% CI 0.95-6.62) and stillbirth (AOR 1.22, 95% CI 0.58-2.57) did not reach significance. Amongst twins alone, maternal age <18, poor education and antenatal care, nulliparity, vaginal bleeding, non-cephalic presentations, birth weight discordance >15%, born second, preterm birth and low birthweight were associated with perinatal mortality. Marriage and caesarean section were protective. Twin pregnancy is a significant risk factor for maternal and perinatal morbidity and mortality in low-resource settings; maternal risk and access to safe caesarean section may determine safest mode of delivery in LMICs. Improving obstetric care in twin pregnancies, particularly timely access to safe caesarean section, is required to reduce risk to mother and baby.
    Full-text · Article · Aug 2013 · PLoS ONE
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    ABSTRACT: We sought to describe obstetric care capacity of nongovernment organization (NGO)-/faith-based organization (FBO)-run institutions compared to government-run institutions in 3 African countries using the World Health Organization Global Survey. We also compared delivery characteristics and outcomes. This is a descriptive analysis of the 22 NGO-/FBO-run institutions in Uganda, Kenya and Democratic Republic of Congo delivering 11,594 women, compared to 20 government-run institutions delivering 25,825 women in the same countries and period. Infrastructure, obstetric services, diagnostic facilities, and anesthesiology at NGO/FBO institutions were comparable to government institutions. Women delivering at NGO/FBO institutions had more antenatal care, antenatal complications, and cesarean delivery. NGO/FBO institutions had higher obstetrician attendance and lower rates of eclampsia, preterm birth, stillbirth, Apgar <7, and neonatal near miss. NGO/FBO institutions are comparable to government institutions in capacity to deliver obstetric care. NGO/FBOs have been found effective in providing delivery care in developing countries and should be appropriately recognized by stakeholders in their efforts to assist nations achieve international goals.
    Full-text · Article · Dec 2012 · American journal of obstetrics and gynecology
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    ABSTRACT: A common prophylactic intervention used in the third stage of labor to reduce postpartum hemorrhage (PPH) can be labeled as active management. In the full management package used for active management, oxytocin is administered soon after delivery in combination with controlled cord traction. However, because the proper use of controlled cord traction requires manual skills, this procedure has been recommended only for skilled birth attendants. Unfortunately, a substantial proportion of maternal deaths from hemorrhage occur in settings in which skilled birth attendants are not available. Some evidence suggests that a simplified active package omitting controlled cord traction may have a similar effect on preventing blood loss, indicating that the uterotonic component in active management may be effective on its own. The contribution of controlled cord traction to blood loss is largely unknown. This multicenter, noninferiority, randomized controlled trial investigated the effect of a simplified management package omitting controlled cord traction from active management on third-stage blood loss. The study was conducted between 2009 and 2010 in 16 hospitals and 2 primary health care centers in Argentina, Egypt, India, Kenya, the Philippines, South Africa, Thailand, and Uganda. Eligible women expecting planned singleton vaginal deliveries (not planned cesareans) were randomly assigned to placental delivery with the simplified package (with aid of gravity and maternal effort) or full package (controlled cord traction applied immediately after uterine contraction and cord clamping). Women were stratified by country. Intramuscular oxytocin 10 IU was administered in both groups immediately after birth with cord clamping after 1 to 3 minutes. Uterine massage was performed after placental delivery according to the local policy in each country. Blinding of investigators, participants, or assessors was not possible after randomization. The primary (noninferiority) outcome was severe PPH (blood loss of ≥1000 mL). The prestated noninferiority margin for the risk ratio was 1.3. Primary analysis was according to modified intention to treat, excluding women who had emergency caesarean deliveries. For the final analysis, 11,861 women were randomly assigned to the simplified package and 11,820 to the full package group. The data showed that for the primary outcome of blood loss of 1000 mL or more, the risk ratio was 1.09 (95% confidence interval [CI], 0.91-1.31), and the upper 95% CI limit crossed the prestated noninferiority margin of 1.30. One case of uterine inversion was observed in the full package group; other adverse events were hemorrhage related. These findings show that omission of controlled cord traction has little impact on the risk of severe hemorrhage. The data suggest that oxytocin can be used as the routine uterotonic for prevention of PPH in settings where a trained health care worker is not available.
    No preview · Article · Sep 2012 · Obstetrical and Gynecological Survey

  • No preview · Article · Jul 2012 · Pregnancy Hypertension
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    ABSTRACT: Hypertensive disorders during pregnancy contribute greatly to maternal and perinatal morbidity and mortality in developing countries. The pathogenesis of such conditions may be illuminated by exploring their relationship to anemia.Objectives To determine whether several types of anemia are risk factors for hypertensive disorders during pregnancy in developing countries.Methods Using data from the World Health Organization Global Survey for Maternal and Perinatal Health, collected in hospitals in six African and six Latin American countries from 2007 to 2008 and in four Asian countries from 2004 to 2005, we examined the associations between severe anemia, sickle cell disease and thalassemia and gestational hypertension or preeclampsia/eclampsia. After exclusions for comorbidities (chronic hypertension, diabetes, HIV infection) and missing data, the severe anemia, sickle cell disease, and thalassemia groups consisted of 219,627, 117,383, and 9376 women, respectively.ResultsMultiparous women with severe anemia were at an increased risk of gestational hypertension (adjusted odds ratio (OR): 1.58; 95% confidence interval (CI): 1.15–2.19). Severe anemia had a significant association with preeclampsia/eclampsia for nulliparous (OR: 3.55; 95% CI: 2.87–4.41) and multiparous (OR: 3.94; 95% CI: 3.05–5.09) women. Sickle cell disease exhibited a significant association with gestational hypertension among nulliparous (OR: 2.49; 95% CI: 1.46–4.25) and multiparous (OR: 3.27; 95% CI: 2.33–4.58) women. No significant associations were found between sickle cell disease and preeclampsia/eclampsia, or between thalassemia and either gestational hypertension or preeclampsia/eclampsia.Conclusion Severe anemia appears to be a risk factor for preeclampsia/eclampsia, while sickle cell disease appears to be a risk factor for gestational hypertension among women seeking hospital care in developing countries.
    No preview · Article · Jul 2012 · Pregnancy Hypertension
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    ABSTRACT: A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site. If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia. ClinicalTrials.gov Identifier NCT01428830.
    Full-text · Article · Mar 2012 · BMC Women's Health
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    ABSTRACT: Active management of the third stage of labour reduces the risk of post-partum haemorrhage. We aimed to assess whether controlled cord traction can be omitted from active management of this stage without increasing the risk of severe haemorrhage. We did a multicentre, non-inferiority, randomised controlled trial in 16 hospitals and two primary health-care centres in Argentina, Egypt, India, Kenya, the Philippines, South Africa, Thailand, and Uganda. Women expecting to deliver singleton babies vaginally (ie, not planned caesarean section) were randomly assigned (in a 1:1 ratio) with a centrally generated allocation sequence, stratified by country, to placental delivery with gravity and maternal effort (simplified package) or controlled cord traction applied immediately after uterine contraction and cord clamping (full package). After randomisation, allocation could not be concealed from investigators, participants, or assessors. Oxytocin 10 IU was administered immediately after birth with cord clamping after 1-3 min. Uterine massage was done after placental delivery according to local policy. The primary (non-inferiority) outcome was blood loss of 1000 mL or more (severe haemorrhage). The non-inferiority margin for the risk ratio was 1·3. Analysis was by modified intention-to-treat, excluding women who had emergency caesarean sections. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN 12608000434392. Between June 1, 2009, and Oct 30, 2010, 12,227 women were randomly assigned to the simplified package group and 12,163 to the full package group. After exclusion of women who had emergency caesarean sections, 11,861 were in the simplified package group and 11,820 were in the full package group. The primary outcome of blood loss of 1000 mL or more had a risk ratio of 1·09 (95% CI 0·91-1·31) and the upper 95% CI limit crossed the pre-stated non-inferiority margin. One case of uterine inversion occurred in the full package group. Other adverse events were haemorrhage-related. Although the hypothesis of non-inferiority was not met, omission of controlled cord traction has very little effect on the risk of severe haemorrhage. Scaling up of haemorrhage prevention programmes for non-hospital settings can safely focus on use of oxytocin. United States Agency for International Development and UN Development Programme/UN Population Fund/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research.
    Full-text · Article · Mar 2012 · The Lancet

  • No preview · Article · Jan 2012 · Obstetric Anesthesia Digest

Publication Stats

702 Citations
324.45 Total Impact Points

Institutions

  • 2009-2015
    • World Health Organization WHO
      • Department of Reproductive Health and Research (RHR)
      Genève, Geneva, Switzerland
  • 2014
    • UNICEF
      New York, New York, United States
    • University of São Paulo
      San Paulo, São Paulo, Brazil
  • 2009-2014
    • United Nations Development Programme
      New York, New York, United States
  • 2013
    • University of Western Australia
      • School of Population Health
      Perth City, Western Australia, Australia
  • 2007
    • Harvard University
      Cambridge, Massachusetts, United States