Active clinical trials for "Stillbirth"

Obesity is a growing problem in East London and every other woman who enters pregnancy is obese or overweight. In addition to obesity, other metabolic risk factors such as raised lipids, high blood pressure and diabetes increase pregnancy related complications such as preeclampsia and long term problems such as heart diseases, stroke and death. Preeclampsia, presenting as hypertension and proteinuria is a leading cause of maternal and fetal mortality and morbidity. Interventions that reduce cardiovascular events by modifying risk factors also have the potential to reduce the risk of preeclampsia. The investigators work funded by the National Institute of Health Research (NIHR) in the UK showed that dietary interventions in obese pregnant women may reduce the risk of preeclampsia. The investigators propose to show that pregnant women with metabolic risk factors derive the most benefit from a simple, targeted intervention based on Mediterranean dietary pattern to reduce the risk of maternal and fetal complications . Women with the risk factors (1230 women) will be randomly allocated to dietary intervention or usual antenatal dietary advice and the risk of maternal and fetal complications will be evaluated. The remaining eligible women who are consented for lipid tests, but do not have metabolic risk factors, will be followed up for outcome data only. Diet based interventions, especially those based on a Mediterranean dietary pattern has a potential to reduce the risk of preeclampsia. In the investigators study, pregnant mothers with risk factors will be randomly allocated to either a dietary invention or usual antenatal care and they will assess their composite maternal (pre-eclampsia or gestational diabetes) and fetal (stillbirth, small for gestational age or admission to neonatal intensive care unit) outcomes. The investigators will tailor the intervention to suit the individual needs of the mother and provide nuts and olive oil to improve compliance. The study will be undertaken across the three maternity units at Barts Health NHS Trust, which delivers 17,000 women/year and two other maternity units in England. The study is supported by the office of the Mayor of Tower Hamlets which will facilitate the involvement of grassroots workers to promote recruitment and uptake of the intervention.

The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in >28 week or >1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.

The purpose of this study is to evaluate the role of an integrated strategy at selecting fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.

The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid alone.

The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.

Inequalities in stillbirth, infant and child mortality as well as other reproductive health outcomes have been reported among ethnic minority groups in Denmark. The MAMAACT study aims to improve the communication between non-Western immigrant women and midwives regarding body symptoms that need prompt reaction, and thus improve perinatal health. 19 of 21 maternity wards in Denmark participate in the study. By simple randomization 10 maternity wards have been selected to the intervention group and 9 maternity wards to the control group. The intervention consist of post graduate training of midwives in intercultural competence and use of health education materials (leaflet and app) on pregnancy warning signs. The intervention will be implemented in the antenatal care from October 2018- September 2019. The training is expected to reach 350 midwives working with antenatal care and 27000 pregnant women, of whom 2700 are expected to be non-Western migrant women. The effect of the MAMAACT intervention will be analyzed by assessing women's ability to actively engage with health care providers (primary outcome), women's knowledge about warning signs of pregnancy complications and health system navigation using survey data. Secondary outcomes are 5-minute Apgar score, umbilical-cord blood gas analysis, transfer to a neonatal intensive care unit, gestational age at birth, fetal birthweight according to gestational age and ICD-10 code for sign of asphyxia. MAMAACTs overall target group is all pregnant women, and the specific target group is women of non-Western origin. Therefore, the outcomes of the trial will be analysed for both the total population and for the effects among non-Western immigrant women specifically. Hypothesis: Training of midwives in intercultural competence and increased attention to communication of warning signs of pregnancy during antenatal care will improve the communication and interaction between women and midwives, improve health literacy of the women and enable them to better access the relevant care in case of a pregnancy complication, which will then increase survival and health of newborn children.

There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. Investigators planned to evaluate the impact of a low-cost package of community-based interventions implemented through government sector lady health workers (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on perinatal and neonatal outcomes in a sub-population of the remote mountainous district of Gilgit, Northern Pakistan. A community-based package for use by LHWs and CHWs geared towards prevention and promotion of maternal and newborn health practices and services will be developed based on formative research in the study district. The package will include promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level. The health workers will be trained in recognition of danger sign that warrant referral to health care service. LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period. In addition to this, community mobilization activities included formation of CHCs and creation of support for the uptake of the interventions. Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area. The intervention areas will receive the intervention package in addition to the routine standard health services. Outcome measures will include changes in maternal and newborn-care practices and perinatal and neonatal mortality rates between the intervention and control areas.

In many low-income countries, the use of ultrasound by medical officers and non-physician health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a new intervention requiring authoritative investigation. The primary hypothesis to be assessed in this study is that antenatal ultrasound screenings performed by medical officers and non-physician health care staff will significantly reduce a composite outcome consisting of maternal mortality and maternal near miss, stillbirth and neonatal mortality in low-resource settings. Underpinning this hypothesis are two assumptions. The first assumption is that antenatal detection of complicated pregnancies will lead to appropriate referral at the right time for complicated pregnancies to comprehensive emergency obstetric and neonatal care (EmONC) facilities. The second assumption is that ultrasound's introduction will increase antenatal attendance leading to greater rates of institutional delivery. To assess these underlying assumptions beyond the composite end point, this study will investigate the health system impact of compact ultrasound. Secondary outcomes include antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent) and an assessment of medical officers and non-physician health care provider ultrasound competence and training quality.

Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and psychologically painful for the couple and the healthcare team. In this difficult context, it is essential to understand the etiology of death to guide the management of subsequent pregnancies. Among the investigations, foetopathologic examination is essential, but the examination of the brain is not possible in more than half of the cases due to the cerebral maceration due to the incompressible delay between death and expulsion. The use of MRI as a diagnostic tool fetal post- mortem " virtual autopsy " performed before expulsion of the fetus is interesting because it would permit to obtain a macroscopic examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI abnormalities are found , it will not only guide the foetopathologic review, but mainly to guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the couple would be better than autopsy which is often refused by the couple in this difficult psychological context. In this study , MRI will be given in addition to conventional autopsy in the painful waiting time between the time of diagnosis of death and expulsion without delaying care . If this study is validated , MRI may be systematically proposed in this indication or alternative to autopsy when it will be refused by the parents.

One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions. This step should ensure the complete retrieval of the surgical specimen with concomitant preservation of its integrity (if possible) in order to avoid intraabdominal contamination of potentially infected or malignant tissues. Possibilities for specimen extraction during laparoscopy include minilaparotomy, enlargement of an ancillary port, transumbilical extraction, and transvaginal extraction through posterior colpotomy. Although recent evidence has already suggested that transvaginal extraction through posterior colpotomy is a safe and feasible option, to date there are no published data about obstetric outcomes after this procedure. For this reason, the current study aims to evaluate obstetric outcomes between women that underwent transvaginal specimen extraction through posterior colpotomy and women who did not.