1117508 / Continuation of SAFE (Incorporating RAPID)

Continuation of SAFE (Incorporating RAPID) (Study due to close 30/09/2018)

1305789 / Exome Sequencing in Families with POI

Exome sequence in POI (Exome Sequencing in Families with Primary Ovarian Insufficiency) (Study due to close 03/09/2014)

1603220 / STOPPIT 2

This study aims to confirm whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix. Preterm birth is associated with increased risk of death and illhealth for the baby, so if preterm birth could be prevented in twins this would be a very good thing.

The Arabin cervical pessary is used to reduce preterm birth in women with a singleton pregnancy (one baby). A Dutch study which finished late last year has suggested that the cervical pessary might also prevent preterm birth in twins.

Although the pessary did not work in all twins, it appeared to reduce preterm birth in those women with a twin pregnancy who had a short cervix (neck of the womb).
The study we propose here will resolve uncertainty around whether the Arabin pessary reduces spontaneous preterm birth in twins and improves outcomes for babies, define any adverse effects for mother and baby, ascertain whether women find the treatment acceptable and will calculate the costs for the NHS.

In a large number of NHS centres, we will ask around 1850 women with a twin pregnancy if they will have an ultrasound scan to measure their cervix around the same time as they have a fetal anomaly scan. Women who are in the lowest 30% of cervical length measurements (around 500) will be asked if they want to join the treatment phase of the study.

Those agree will be treated with either the Arabin pessary, or standard treatment. The pessary will be inserted between the beginning of the 18th to the end of the 20th week of pregnancy, and then removed at 36 weeks. We will look at the proportion of babies who are born before 34 weeks, and the complications that happen to babies and we will compare these between the two groups. We will also perform an economic analysis to determine the cost effectiveness of the Arabin pessary, and ask women about their experience of using the pessary. (Study due to close 31/10/2019)

1711538 / The Cleft Collective Cohort Studies

Cleft lip and/or palate is one of the commonest congenital conditions in the United Kingdom (UK) with an estimated prevalence of 1 in 700 live births. The evidence to support preventive interventions and effective treatments is limited.

Being born with a cleft is now recognised as a major cause of ill health. There is also new evidence emerging which suggests these children need increased educational support and are more likely to have a shorter lifespan, with increased risk for all major causes of death, when compared with those children born without clefts. We do not know if these problems are caused by the genes that may be responsible for cleft or by other factors, such as lifestyle or ‘environmental’ factors.

Our aim is to create the infrastructure, capacity and resources necessary to gain important new knowledge that will advance our understanding of the causes of cleft lip and/or palate, inform treatment and ultimately improve the lives of children, adolescents and adults with the condition. The aim is to create a birth cohort study (recruit babies and their families born with a cleft) and a five year cohort study (recruiting five years olds and their families born with a cleft). (Study due to close 30/09/2019)

1804581 / Helping Pregnant smokers to quit: A multi-centre RCT of electronic cigarettes vs. nicotine patches (usual care)

Smoking in pregnancy remains an unresolved issue. Quit rates in pregnant smokers are low and advice by doctors and nurses, even when combined with behavioural support and nicotine replacement treatment (NRT) has only limited efficacy.

Electronic cigarettes (EC) may overcome these limitations. EC allow flexible dosing and have a faster effect than NRT. They also provide some of the sensations and enjoyment that smokers get from smoking. These characteristics should ensure better treatment adherence.

It is estimated that in the UK half a million smokers switched from smoking to vaping (EC use) so far, with 20,000 quitting smoking with the help of EC per year who would not have quit otherwise. There is thus a strong rationale for testing the efficacy of EC as a stop-smoking treatment for pregnant women.

We propose to randomise 1,140 pregnant smokers to either behavioural support provided by pro-active phone calls and accompanied by nicotine patches, or to the same support accompanied instead by EC. The two study arms would be compared in validated abstinence rates at end of pregnancy and in a number of other outcomes including adverse effects and birth and maternal outcomes.

A positive result would provide a new, inexpensive, and practical tool to tackle an important and so far unresolved problem.

The study will recruit pregnant smokers from hospital sites across England and stop-smoking services in Scotland, and is funded by the NIHR. (Study due to close 01/09/2020)

1805637 / OPTI-Prem

New evidence shows that for babies born at 23-26 weeks, care in one of two types of neonatal units, i.e a Neonatal Intensive Care unit (NICU) as opposed to a Local Neonatal Unit (LNU) improves survival to discharge: this is informing policy that shapes their services. In contrast, there is no evidence to guide location of care for the next most vulnerable group (born between 27-31 weeks) whose care is currently spread between 45 NICU and 84 LNU in England. This group accounts for 4 times more neonatal unit admissions than those born at 23-26 weeks, and 12% of all preterm births in England. They utilise twice as many NHS bed days/year compared to those born at 23-26 weeks, and over a third of all neonatal unit care days.

Our primary objective is to assess, for babies born at 27-31 weeks and admitted to a neonatal unit, whether care in a NICU vs a LNU impacts on survival and key morbidities (to age 1 year), at each gestational age in weeks. This will be achieved through analysis of routinely recorded data extracted from real-time, point-of-care patient management systems and held in the National Neonatal Research Database (NNRD),Hospital Episode Statistics (HES) and Office for National Statistics (ONS)for admissions over the period 01/01/14-31/12/17 in England.

Secondary objectives are whether  differences in clinical care exist between LNU and NICU, and whether these are associated with gestation-specific differences in outcomes; where it is most cost-effective to provide care; and parents’ and clinicians’ perspectives on place of care, and how these can guide clinical decision-making.

The information will be used to develop recommendations, in collaboration with national bodies, to inform clinical practice, commissioning and policy making. (Study due to close 31/08/2018)

1812723 / Developing a training intervention for midwives and women to enhance implementation of pelvic floor muscle exercises (PFME) in the ante- and post-natal period

This series of studies will contribute to the development of an intervention to support implementation of pelvic floor muscle exercises (PFMEs) in pregnancy. This forms the third stage, Work Package 3 (WP3), of the NIHR-funded ‘Antenatal Preventative Pelvic Floor Exercises and Localisation’ (APPEAL) programme. APPEAL aims to prevent pregnancy and childbirth related urinary incontinence (UI) by developing and testing a motivational training package for midwives to help women perform PFME correctly and regularly. Pregnancy and childbirth are major risk factors for UI. Incontinence places a large burden on women’s health; impacting on physical, mental and social quality of life with associated pressure on NHS resources and wider societal costs. A recent Cochrane review showed the efficacy of PFME for prevention and treatment of UI in pregnant and postnatal women (Woodley et al., 2017).

WP3 will include three linked studies:
3.1: focus groups with midwives and with women will be held across two study sites in London and Exeter. The study will explore preferences and ideas for the best ways to delivery intervention training, and key components that will help midwives teach and support women to carry out effective PFMEs during and after pregnancy.
3.2: a stakeholder event will be held to seek feedback on the proposed intervention and to explore resource requirements for implementation within maternity services
3.3: a practice training event with midwives will be held to get feedback on the intervention. This will refined prior to testing in a subsequent clinical trial as part of the APPEAL study programme grant (not included in this application). (Study due to close 31/10/2018)