Clinical Research Directory

Mothers Working to Prevent Early Stillbirth Study 20-28

This project aims to identify factors linked to pregnancy losses occurring between 20 and 28 weeks of pregnancy that can be modified by changing mother's behaviour or healthcare provision. The death of a child before birth (also called stillbirth or miscarriage) has enduring psychological, social and economic effects for women, their families and wider society. In 2015, the stillbirth rate in the UK was higher than comparable countries. The UK government has committed to reduce stillbirths by 50% by 2025. Presently, stillbirths after 28 weeks of pregnancy have reduced by 16% but there has been no change in losses between 20 and 28 weeks of pregnancy with 1,600 losses estimated to occur at this stage of pregnancy each year. Identification of modifiable causes of stillbirth was identified as a research priority by the Stillbirth Priority Setting Partnership which involved over 1,000 participants, one third of whom were bereaved parents. The investigators previously completed a study of 291 women who had a late stillbirth (after 28 weeks of pregnancy) and 733 women who had a live baby in 41 maternity units in the UK. This study identified factors linked to stillbirth which can be changed including the position women go to sleep in, cigarette smoking and caffeine consumption. In addition, the investigators previously found changes in mother's perception of baby's movements, whether women had tests for diabetes or whether women were exposed to domestic violence or stressful situations. These factors can be addressed by different care in pregnancy. Information from this study has been included in national and international guidelines that aim to reduce stillbirth. The investigators will use the same study type to identify factors associated with pregnancy loss between 20 and 28 weeks of pregnancy (early stillbirth). The investigators have asked parents who have experienced the death of a baby at these stages of pregnancy about the design of the study, the questions that would be asked and how best to approach bereaved parents. This led us to include miscarriages from 20-22 weeks of pregnancy that are not usually "counted" in UK stillbirth statistics. The investigators will need 316 women with stillbirth between 20 and 28 weeks of pregnancy and 632 women with an ongoing live pregnancy to participate in the study. All women will complete a questionnaire about themselves, their diet, behaviours and sleep, their baby's movements and pregnancy care. The investigators will compare information between women who have early stillbirth and those who have a live birth to identify factors associated with stillbirth at less than 28 weeks of pregnancy. The study findings will be disseminated in collaboration with patient organisations using effective ways to reach pregnant women. The investigators anticipate the findings from this study will be included in clinical practice guidelines and rapidly translated into antenatal care.

AI-POCUS for Maternal and Neonatal Health in Ethiopia

Maternal and neonatal health remains one of the most pressing global health challenges, particularly in low- and middle-income countries (LMICs). Ethiopia continues to face a high burden, with maternal mortality estimated at 195 per 100,000 live births, neonatal mortality at 27 per 1,000 live births, and perinatal mortality rates ranging from 37‰ to 124‰ depending on the level of care. These outcomes remain substantially higher than the targets set under the United Nations Sustainable Development Goals (SDGs) for 2030. The World Health Organization (WHO) recommends that all pregnant women receive at least one ultrasound scan before 24 weeks of gestation, yet nearly two-thirds of women worldwide-especially in LMICs-lack access to this service. Barriers include high costs of ultrasound machines, limited technical expertise, and shortages of skilled sonographers in rural primary care. Artificial Intelligence-driven Point-of-Care Ultrasound (AI-POCUS) represents a promising innovation to expand prenatal imaging in resource-constrained settings by equipping frontline health workers with AI-supported diagnostic capabilities. This study, conducted under the Tsinghua University BRIGHT (Bringing Research to Impact for Global Health at Tsinghua) program, will evaluate the clinical effectiveness, feasibility, cost, and scalability of AI-POCUS in rural Ethiopia. A three-arm cluster randomized controlled trial will compare two AI-enabled ultrasound technologies-BabyChecker (Netherlands) and a China-developed AI-POCUS device-against standard antenatal care without ultrasound. Findings will generate robust clinical and policy-relevant evidence to guide the sustainable implementation of AI-enabled maternal health interventions in sub-Saharan Africa.

Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child. It is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia. This triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.

Parents' Experience of Child Loss During Pregnancy or Birth

The investigators are conducting a participatory study with and for parents after child loss during pregnancy or birth. Their aim is to develop treatment recommendations for healthcare professional. These focus on question, how to deal with parents when experiencing child loss.