NIHRDataInsights/HRCSData huggingface dataset:
Title: Mode of delivery after caesarean section: An investigation of offspring risks and factors influencing women's attitudes towards delivery options.
Funder: Wellcome Trust

Abstract: This project aims to address two topical issues relating to caesarean section (C/S), an increasingly common procedure which carries many costs and consequences. The study is designed to investigate how planned caesarean section in women who have had a previous C/S may increase the risk of the babies developing certain illnesses in childhood. It is also intended to investigate reasons why women prefer C/S or vaginal birth from a psychological perspective. The rate of various medical conditions wi ll be compared between children delivered by planned repeat C/S with those where an attempt was made to achieve vaginal birth after previous C/S (VBAC). A comprehensive review of published literature will be carried out to collate the existing evidence on why women prefer either repeat C/S or VBAC. A questionnaire study will then be performed in; 1) women in their first pregnancy who will receive the questionnaire in the middle of their pregnancy and again six weeks after birth 2); women in thei r second pregnancy with a history of C/S, who will receive an extended questionnaire sent during late pregnancy only. This questionnaire will be based on psychological theory which has been found to explain why people do things in other contexts.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;2.4 SURVEILLANCE AND DISTRIBUTION
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: The role of hypoxia inducible factor in endometrial repair: a potential therapeutic target for heavy menstrual bleeding
Funder: Wellcome Trust

Abstract: The lining of the womb (endometrium) is shed monthly during a period and, unlike other tissues, usually repairs efficiently without scarring or loss of function. One in three women has periods that are too heavy, decreasing her quality of life. Defective repair increases blood loss but the mechanisms to stop bleeding and initiate repair remain undefined. A master regulatory protein is likely to co-ordinate repair factors in the endometrium. Our research suggests that hypoxia-inducible factor (HI F) increases repair factors during bleeding and that women with heavy periods have low levels of HIF. We are unsure if this is a cause or consequence of heavy bleeding. Determining the exact role of HIF in endometrial repair is difficult in women, due to individual differences and the need for repeated samples. To overcome these problems, we wish to mimic menstruation in a mouse and examine endometrial repair when they have normal, reduced or increased HIF. This is achieved using medications o r switching on/off the gene for HIF. Endometrial samples will be taken to examine the repair process. This allows us to fully understand how HIF influences repair and may identify a much needed non-hormonal, non-surgical treatment for women with heavy periods.


Research activity codes: 1.1 NORMAL BIOLOGICAL DEVELOPMENT AND FUNCTIONING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Is Commercial Surrogacy Exploitative? A philosophical analysis of the concept of exploitation within commercial surrogacy arrangements, using the industry in India as a case study.
Funder: Wellcome Trust

Abstract: I will expound a unique theory of exploitation. In doing so, I develop an analytic framework that is composed of a sufficient condition for what it is to be exploited, and demonstrate that commercial surrogacy arrangements in India satisfy this condition. This sufficient condition, is preliminarily that, B is exploited by A when B's vulnerability is used by A to take unfair advantage of B. I will need to theorise vulnerability as a state that precedes being exploited; surrogates vulnerability is used to then take unfair advantage, and this is what constitutes the exploitation. I need to define and conceptualise the notion of gaining unfair advantage and how it applies in this context, relating to the surrogate's capacity to bear children. I then need to demonstrate that surrogacy in India satisfies this condition, and so can be seen as exploitative. I will do so by analysing empirical and ethnographic data relating to the surrogate's circumstances, which shows the ways in which they ar e vulnerable, and provide an argument for how this contributes to their exploitation. I also need to consider the moral force of this exploitation, and why it is of ethical interest, despite its purportedly mutually advantageous nature.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Novel genes underlying the timing of puberty.
Funder: Wellcome Trust

Abstract: Puberty is the developmental stage at which adolescents reach sexual maturity. Disturbances of pubertal timing affect over 4% of the population; however, little is known about the biological processes that control its onset. Studies suggest that genetic factors are central to controlling pubertal timing; however, the majority of these factors remain undiscovered. My project investigates families affected by a well-recognised condition called Familial Constitutional Delay of Growth and Puberty ( CDGP), where the timing of puberty is significantly delayed. Using the latest genetic and computational techniques, in my preliminary work I have identified 2 genes potentially causing pubertal delay. One of these is known to cause complete pubertal failure, but the other has not previously been associated with pubertal timing. I will perform laboratory-based studies to clarify the function of these genes and their role in the timing of puberty. I hope that identification of the genetic factors that lead to CDGP will aid understanding of the genes and biological pathways that control the onset of puberty, and ultimately improve treatment of patients with disturbances of pubertal timing. This understanding also has a public health impact as there is a trend towards an earlier onset of puberty in the general population.


Research activity codes: 1.1 NORMAL BIOLOGICAL DEVELOPMENT AND FUNCTIONING;2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Structural vulnerabilities and maternal health among Mexican indigenous populations.
Funder: Wellcome Trust

Abstract: This research project will ask how structural inequalities operate through everyday activities to put indigenous people more at risk of illness and premature death. To answer this, I will conduct an in-depth study of maternal health in Mexican indigenous communities from the position of structural violence, a concept that explains how structural inequalities put marginalised people particularly in harms way. Using ethnography I will explore how social, cultural, economic and political structures operate to determine health. The project will begin with a review of research on structural violence relating to women's health in order to identify risk factors. The ethnography will centre on interviews with twenty pregnant women and twenty key informants. I will explore how social, cultural, economic and political structures operate affect agency by limiting individual decision making. Data will be analysed for theoretical interpretation and will feed into a series of Focus Group Discuss ions through which stakeholders and community members will develop an intervention strategy that addresses the fall out of structural violence on community and structural levels. Goals are: 1)Conduct an ethnography of maternal health 2) Develop an intervention strategy to address this on community and structural levels.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;2.3 PSYCHOLOGICAL, SOCIAL AND ECONOMIC FACTORS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: The perceptions, experiences and future expectations of sperm donors: a comparison between men donating sperm through a licensed sperm bank and an unregulated website.
Funder: Wellcome Trust

Abstract: Men donating sperm at a licensed fertility clinic will have no legal obligation to a child born from their donation, or any role in their upbringing. However, since a change in the law in 2005, donor-conceived offspring can request the identity of their donor once they reach the age eighteen. Men can also choose to donate sperm through connection websites. These sites enable women to connect with and arrange sperm donation directly with men willing to donate. The donors can be known to, and play a role in, the childs life or could choose to remain completely anonymous. Connection sites have raised medical, ethical and social concerns, with some dubbing them the 'seedy, sinister side of the sperm trade'. This research will explore the thoughts, experiences and expectations of men donating sperm through these two routes, uncovering reasons why some men may choose to donate through a connection website rather than a clinic, and how both groups of men feel about the child who may be born a s a result of their donation. The results of this research will help improve donation services and prepare for the time when donor conceived offspring start to request the identity of their donor.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: The New Politics of Abortion: A critical examination of incrementalist lobbying strategies in the USA and UK.
Funder: Wellcome Trust

Abstract: The United Kingdom is witnessing an increase in lobbying against abortion provision. The rhetoric employed is not directed towards whether abortion is morally right or wrong. Rather the aim is to restrict access to services based on concerns about patient protection and the activities of abortion providers. These attacks on service seek to hinder the activities of abortion providers in indirect and incremental ways. This mirrors strategies evident in the USA since the late 1990s. Incremental tac tics to reduce access to abortion services became popular following publications such as Firestorm: A Guerrilla Strategy for a Pro-life America that aimed to give rise to an America where abortion may indeed be perfectly legal, but no one can get one. The objective of this visit is to conduct comparative research on abortion lobbying and law reform. I will be based at the ONeill Institute for Global and National Health Law at Georgetown University. This is a world-leading health law institute and will provide the ideal academic environment for my research. Being in Washington DC also means that I have access to vital sources for my research; specifically the Library of Congress and the Center for Reproductive Rights.


Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH
Title: Molecular, genetic and life course approaches to investigate the role of reproductive factors on risk of breast cancer in women
Funder: Wellcome Trust

Abstract: Breast cancer (BrCa) is one of the most common forms of cancer, affecting 1 in 7 women and accounting for 7% of all deaths in the UK between 2015-2017. Numerous risk factors have been associated with BrCa including age, family history and body mass index, as well as factors involved in women’s reproductive health. Reproductive events such as early puberty and later menopause have been associated with increased BrCa risk. Much of the current literature has assessed reproductive events independently without consideration of other reproductive events, and these event’s causal role in BrCa development has not been fully investigated. My aim is to use multiple approaches to explore the role of reproductive events for improving understanding of BrCa. Firstly, I will assess how these reproductive events have an effect, either independently or in combination, on BrCa risk, across the life course. Secondly, I will use newly developed methods to further assess if reproductive events play a role in causing BrCa. Finally, I will assess to what extent epigenetic modifications, changes to the DNA which influence gene regulation, play a role in the relationship between reproductive events and BrCa. This work will improve our understanding of the causes of BrCa.


Research activity codes: 2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CANCER AND NEOPLASMS
Title: Understanding, Predicting and Diagnosing Adverse Pregnancy Outcomes in Women with Chronic Hypertension
Funder: Department of Health (England)

Abstract: Chronic hypertension (CHT) affects as many as 33,000 pregnant women in the UK every year and is associated with significant complications for both mother and baby, including pre-eclampsia, placental abruption, delivery of small for gestational age infants and increased perinatal mortality. Current methods of predicting adverse pregnancy outcomes are limited. I propose a study to evaluate urinary biomarkers across gestation in women with CHT using established and novel techniques, including proteomics. This will facilitate development of a screening test for adverse outcomes and enhance mechanistic understandingof the pathophysiology. I shall also investigate the potential of urinary biomarkers for discrimination between progressivehypertension/ proteinuria (usually managed expectantly) and superimposed pre-eclampsia (often necessitating delivery), a distinction that presents a significant clinical challenge. 78 women with CHT will be recrtuited for assessment of known candidate biomarkers, together with evaluation of the urinary proteome (in collaboration with an industrial partner embedded within the core proteomics facility at King’s College London) in the 1st, 2nd and 3rd trimesters and at time-of-disease. This will enable development of predictive and diagnostic tests using a panel of biomarkers. Gaining mechanistic understanding will also facilitate development of prophylactic or therapeutic interventions that could be tailored to the underlying disease process.


Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CARDIOVASCULAR
Title: Developing a Core Outcome Set for Hypertensive Disorders in Pregnancy
Funder: Department of Health (England)

Abstract: Background Currently studies evaluating potential treatments for blood disorders in pregnancy measure many different outcomes. When the studies have finished their results cannot be easily compared or combined. Objective This study will develop a set of core outcomes for blood pressure disorders in pregnancy studies. Design Patient interviews, surveys, and meetings will draw together the opinions of researchers, healthcare professionals, and patients. Benefits to NHS Patients If all studies use the same outcomes they could be compared and combined. This would help patients, clinicians, and guideline developers make the best use of available research.


Research activity codes: 1.4 METHODOLOGIES AND MEASUREMENTS;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CARDIOVASCULAR
Title: 2014 Doctoral Fellowship: Clinical utility of 3D power Doppler ultrasound and maternal biomarkers in the prediction of pre-eclampsia in high risk pregnancies
Funder: Health and Social Care Research and Development Division (HSC R&D) of Public Health Agency, Northern Ireland

Abstract: Globally, pre-eclampsia is a major cause of maternal and fetal morbidity and mortality. The cause of pre-eclampsia remains unclear and delivery is the only known cure. Approximately 4% of all pregnant women develop pre-eclampsia; women with diabetes mellitus, autoimmune disease, thrombophilia, obesity, a history of previous pre-eclampsia or intrauterine growth restriction (IUGR) are particularly at risk with reported incidences of pre-eclampsia of up to 20%. Additionally, these pregnancies are at increased risk of fetal complications: miscarriage, stillbirth, IUGR, macrosomia, pre-term delivery, complications of prematurity and admission to the neonatal unit. Evolving evidence suggests that an integrated booking visit combining medical history, ultrasound parameters and serum biomarkers may be of use in defining the patient-specific risk for a wide spectrum of pregnancy complications, including pre-eclampsia. To date, there are little data on the use of such integrated tests in high risk populations. Against that background, the aim of this study is to examine the ability of Doppler ultrasound and maternal biomarkers measured in the first and second trimesters of pregnancy to predict PE and other adverse outcomes in women who are at high risk. Predictive markers will include a combination of clinical variables, 3D Doppler ultrasound measurement of placental indices and uterine artery dopplers and specific serum biomarkers (PAPP-A, PlGF, sFLt-1, sEng, HbA1c). Ultimately, this novel approach has the potential to facilitate more appropriate planning of antenatal care and the introduction of timely interventions to help prevent maternal and fetal complications.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CARDIOVASCULAR
Title: Cardiovascular consequences of preeclampsia in women from the Generation Scotland: Scottish Family Health Study
Funder: Chief Scientist Office (Scotland)

Abstract: There is evidence that preeclampsia directly causes alterations in the cardiovascular (CV) system which increase future CV risk: endothelial dysfunction, cardiac dysfunction and hypertrophy were shown to be still present 2 years after preeclampsia. The long-term consequences (>10 years), however, have not been studied. We will examine whether cardiovascular damage is greater in women who had preeclampsia 10 to 30 years ago than in women who had a healthy pregnancy 10 to 30 years ago. We will use a multifaceted approach comprising of record-linkage, a biomarker strategy including urinary proteomics and high-fidelity cardiovascular phenotyping. Subjects will be recruited from the Generation Scotland Study, which is ideally suited for this purpose (large database to select cases and controls, blood and urine samples already available, opportunity to contact suitable individuals for further investigations). Our results will have immediate implications for CV risk assessment of women with previous preeclampsia.


Research activity codes: 2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CARDIOVASCULAR
Title: Induction of labour in pre-eclamptic women: a randomised trial comparing balloon catheter with oral misoprostol.
Funder: Medical Research Council

Abstract: Up to 80,000 pregnant women die annually from pre-eclampsia and eclampsia ? many of them in India where there are more maternal deaths than any other country. Current therapies reduce the morbidity associated with pre-eclampsia but the final cure only comes with delivery. Prompt delivery of the baby, preferably by the vaginal route following labour induction, is vital to achieve good maternal and neonatal outcomes. The need for an effective and safe induction method is especially important in low resource settings where the underlying illness is often severe and there are minimal facilities for monitoring of mother and baby. The WHO currently recommends one of two different interventions for low resource settings ? oral misoprostol (OM) and transcervical Foley catheterisation (TFC). Although OM has been widely studied, there is comparatively little research on the TCF. Neither are widely used and the two methods have never been directly compared. Current evidence suggests that OM may be faster but with more uterine hyperstimulation, whilst TFC may be slower but safer. We propose an open label randomised trial of OM (25mcg tablets 2hrly) versus TFC (18F with 50ml balloon for 12 hours). The study will be conducted in two large government hospitals in Nagpur, India and will recruit women with preeclampsia who require induction of labour. Following informed consent, labour induction will be carried out using the selected method, followed by artificial membrane rupture and oxytocin infusion as required. The primary outcome is the attainment of vaginal delivery within 24 hours which is expected in 62% of women in the OM group. To detect an absolute reduction of 10% in this rate (i.e. 62% to 52%) with 80% power (two-sided a =0.05) we will require a sample of 768 women. This number will also have 80% power to detect a reduction in stillbirth rate from 15% (data from a recent study in the same site) to 8.5%. The secondary outcomes will include measures of maternal and neonatal morbidity up to the time of hospital discharge as well as a detailed economic evaluation. Recruitment rates in a recent study of pre-eclamptic women using the same team and site demonstrate that 800 women can be recruited in 2 years. The study will be managed on a daily basis by the successful team of Dr Mundle in GMC Nagpur and Gynuity Health Projects, one of the most successful low-resource setting clinical trial specialists in the world.


Research activity codes: 6.3 MEDICAL DEVICES;6.1 PHARMACEUTICALS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CARDIOVASCULAR
Title: Physical Exercise & Cardiovascular Adaptation Monitoring in Pregnancy (‘PECAMP’)
Funder: Welsh Government Office for Science

Abstract: In 2016, midwives in Wales began referring otherwise healthy pregnant women with BMI>30 kg·m-2 to a new antenatal National Exercise Referral Scheme (NERS) programme. A large body of research supports the general benefit of physical exercise for pregnant women [1,2], but there is a lack of knowledge about the specific influence of exercise on cardiovascular physiology in healthy and overweight pregnant women [3]. The impact of maternal physical activity on foetal cardiac health is also unknown, yet the potential scope for this via cardiac autonomic nervous system (ANS) function evaluation is significant [4]. Furthermore, we do not know whether antenatal exercise influences the behaviour (persistence or resolution) of antenatal cardiovascular adaptations during early postpartum (1-3 months post-birth) [5]. Postpartum evaluation of mother and baby could provide evidence pointing towards longer-term benefits of antenatal exercise.


Research activity codes: 1.1 NORMAL BIOLOGICAL DEVELOPMENT AND FUNCTIONING;6.7 PHYSICAL
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CARDIOVASCULAR