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Stillbirth clinical trials

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NCT ID: NCT03799861 Recruiting - Stillbirth Clinical Trials

Newborn Heart Rate as a Catalyst for Improved Survival

Start date: July 5, 2018
Phase:
Study type: Observational

Heart rate (HR) is not routinely assessed during newborn resuscitations in low- and lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh stillbirths have a heartbeat and are live born. The effect of a low-cost monitor for measuring HR on the problem of misclassification of stillbirths in LMICs is unknown. Knowledge of HR during newborn resuscitation might also result in timely administration of appropriate interventions, and improvement in outcomes. Helping Babies Breathe (HBB), a resuscitation algorithm developed by the American Academy of Pediatrics (AAP), is widely accepted as the standard of care for newborn resuscitation in low-resource settings. In keeping with the International Liaison Committee on Resuscitation (ILCOR) recommendations that HR be measured during newborn resuscitation, HBB calls for HR assessment after 1 minute of positive-pressure ventilation with good chest movement (or sooner if there is a helper who can palpate/auscultate heart rate). However, given the frequent reality of a single provider attending deliveries in LMICs, as well as the currently available methods for assessing HR (i.e. palpitation or auscultation), assessment of HR is challenging to perform without delaying or stopping the provision of other life-saving interventions such as bag and mask ventilation. The effect of low-cost, continuous HR monitoring to guide resuscitation in these settings is unknown. NeoBeat is a low-cost, battery-operated device designed by Laerdal Global Health for the measurement of newborn HR. The device can be placed rapidly on a newborn by a single provider, and within 5 seconds, displays HR digitally. A preliminary trial of NeoBeat in 349 non-breathing newborns in Tanzania detected a HR in 67% of newborns classified as stillbirths, suggesting up to two thirds of fresh stillbirths may be misclassified in similar settings. This trial will evaluate: 1) the effectiveness of HBB in combination with NeoBeat for vital status detection on reduction of reported stillbirths, and 2) the effectiveness of HR-guided HBB on effective breathing at 3 minutes. The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat will decrease the reported total stillbirth rate by 15% compared to standard care. The secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of newborns not breathing well at birth who are effectively breathing at 3 minutes by 50% compared to HBB with NeoBeat.

NCT ID: NCT03775954 Recruiting - Clinical trials for Congenital Heart Disease

Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

Start date: July 1, 2018
Phase:
Study type: Observational

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.

NCT ID: NCT03751774 Recruiting - Stillbirth Clinical Trials

The MAMAACT Intervention

MAMAACT
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03722615 Recruiting - Hearing Loss Clinical Trials

Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa

Start date: May 6, 2016
Phase:
Study type: Observational

The aim of this project is to determine the epidemiology of congenital cytomegalovirus (CMV) infection and incidence of subsequent permanent neurological sequelae in a high HIV prevalent setting in Soweto, Johannesburg. A cross-sectional study will be conducted on mother-infant pairs, screening mothers for CMV infection and newborns for congenital CMV infection. Maternal CMV prevalence will be determined by testing for CMV specific antibodies in blood. Newborn congenital infection will be determined by polymerase chain reaction (PCR) tests on newborn saliva and urine within 3 weeks of birth. Various risk factors associated with congenital CMV such as HIV exposure, and gestational age will be assessed. The association between maternal vaginal CMV shedding postnatally with congenital CMV infection will be explored by swabbing maternal vaginal fluid and conducting quantitative CMV PCR analysis. Newborns confirmed with congenital CMV and a control group of uninfected newborns will form a cohort to be followed up until 12 months of age monitoring for various neurological sequelae such as hearing loss, neurodevelopmental impairment, ocular damage, cerebral damage and seizures. A comparison of vaccine immune responses between cases of congenital CMV and the CMV uninfected infants to the primary series of vaccines in the National Expanded Programme on Immunisation will be compared. The contribution of CMV infection to neonatal death and stillbirths will be described by minimally invasive tissue sampling (MITS) for CMV on babies that die during the neonatal period and stillbirths.

NCT ID: NCT03662178 Recruiting - Stillbirth Clinical Trials

Investigating the Structured Use of Ultrasound Scanning for Fetal Growth

OxGRIP
Start date: September 1, 2017
Phase:
Study type: Observational

Fetal growth restriction during pregnancy represents one of the biggest risk factors for stillbirth (Gardosi et al, 2013), with 'about one in three term, normally formed antepartum stillbirths are related to abnormalities of fetal growth' (MBRRACE, 2015). Therefore, antenatal detection of growth restricted babies is vital in order to be able to monitor and decide the appropriate delivery timing. However, antenatal detection of SGA babies has been poor, varying greatly across trusts in England in those that calculate their rates (NHS England, 2016). Most trusts do not calculate their detection rates and rates are therefore unknown. It is estimated that routine NHS care detects only 1 in 4 growth restricted babies (Smith, 2015). Oxford University Hospitals NHS Foundation Trust, in partnership with the Oxford Academic Health Science Network (AHSN) has introduced a clinical care pathway (the Oxford Growth Restriction Pathway (OxGRIP)) designed to increase the rates of detection of these at risk babies. The pathway is intended to increase the identification of babies who are at risk of stillbirth, in order to try to prevent this outcome, whilst making best usage of resources, and restricting inequitable practice and unnecessary obstetric intervention. It has been developed with reference to a body of research, however, the individual parts of care provided have not been put together in a pathway in this manner before. Therefore it is important to examine whether the pathway meets its goals of improving outcomes for babies in a 'real world' setting. The principles of the pathway are 1. A universal routine scan at 36 weeks gestation. 2. Additional growth scans at 28 and 32 weeks gestation based on a simplified assessment of risk factors and universal uterine artery Doppler at 20 weeks gestation. 3. Assessment of further parameters other than estimated fetal weight associated with adverse perinatal outcome (eg growth velocity, umbilical artery Doppler and CPR). The clinical data routinely collected as a result of the introduction of the pathway offers a valuable and unique resource in identifying and analysing in the effects of the pathway on its intended outcomes and also in investigating and analysing other maternal, fetal and neonatal complications and outcomes, establishing normal / reference ranges for ultrasound values.

NCT ID: NCT03605511 Recruiting - Thrombocytopenia Clinical Trials

TTP and aHUS in Complicated Pregnancies

Start date: September 21, 2018
Phase:
Study type: Observational

A single site observational study aiming to: (i) Identify cases of previously undiagnosed thrombotic thrombocytopenic purpura (TTP) and atypical haemolytic syndrome (aHUS) in a cohort of women with complicated pregnancies (ii) Characterise the clinical features of these cases and (ii) Identify clinical features or biomarkers which may help distinguish TTP/aHUS from other complications of pregnancy such as preeclampsia

NCT ID: NCT03601338 Completed - Clinical trials for Unexplained Stillbirth

Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

Start date: August 1, 2015
Phase: Early Phase 1
Study type: Interventional

Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

NCT ID: NCT03439956 Not yet recruiting - Clinical trials for Pregnancy Complications

Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy

OUTSET-1
Start date: April 1, 2018
Phase: N/A
Study type: Observational

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.

NCT ID: NCT03438110 Enrolling by invitation - Stillbirth Clinical Trials

Asia Pregnancy Outcomes Study

Start date: July 1, 2018
Phase:
Study type: Observational

Preterm birth is a major cause of child mortality and morbidity, most of which occurs in south-east Asia and sub-Saharan Africa. To date few neonatal cause of death studies, especially in low- and middle-income countries have determined the specific causes of preterm death, instead attributing all neonatal deaths of infants born at less than 37 weeks to prematurity. Infections are responsible for a large proportion of these deaths but because of complexity and costs associated with testing, little is known about the prevalence of infection-related deaths in preterm infants or the specific pathogens associated with mortality. The primary objective of this study is to determine the cause of deaths among preterm births and stillbirths. Secondary outcomes include determining the specific pathogens responsible for infection-related deaths, potential preventability of these deaths and interventions which may reduce mortality. One site in India and one in Pakistan will include a total sample size of 700 (350 stillbirths and 350 preterm neonatal deaths) for 1,400 cases to be included in the cause of death analyses. All women who deliver a preterm birth or a stillbirth at the study hospitals will be eligible for inclusion. Among those who consent, an obstetric history, clinical obstetric and (if applicable) neonatal care will be collected as well as research investigations including ultrasound, x-ray, microbiology and minimally invasive tissue sampling and autopsy will be collected. This study will align with other efforts to determine cause of death among infants and children and ultimately the results will inform future interventions to reduce neonatal mortality and stillbirth. The researchers emphasize that this study, with its focus on preterm neonatal mortality and stillbirth, will provide information not available elsewhere.

NCT ID: NCT03363308 Active, not recruiting - Stillbirth Clinical Trials

Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa

Start date: November 16, 2017
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.