Overview of the Research

Around 6000 women give birth at the Bradford maternity unit each year, it is a busy unit, but research, like quality clinical care and safety is integral to our unit. By taking part in large well-designed trials the Bradford maternity unit contributes to the generation of high quality evidence that will improve the health and well-being of women and their infants. It is important that all women have the opportunity to take part in research, so we aim to ensure that all women are aware of what research studies are being conducted in their maternity unit.

The research and clinical teams identify potentially eligible women and provide them with information about the research study. If a woman is eligible and agrees to take part, the team will enroll her in the study. The team keeps in close contact with the woman throughout the research period, which can be up to one or two years after birth.

We collaborate with colleagues across the UK and overseas to ensure the important questions that will make a real difference are answered. We also conduct our own research. Our research interests include: gestational diabetes, hypertensive disorders of pregnancy and maternal and child obesity.

Current On-going studies:

1) TTTs Multiple Pregnancy Registry: Is a registry collecting information about complicated twin pregnancies and triplet pregnancies. This will enable long term follow up and help us to identify how care and treatment for women with these pregnancies can be improved.

2) GIANT PANDA: The study aims to investigate the effectiveness on reducing high blood pressure with medication (Nifedipine versus Labetalol) on maternal and fetal/neonatal outcomes in women with pregnancy hypertension and pre-eclampsia.

3) C-STICH2: This study aims to find out if an emergency cervical stitch (cerclage) reduces pregnancy loss (miscarriage, termination of pregnancy, stillbirth or neonatal death within 7 days of delivery) in women who have threatened pre-term labour.

4) GBS3: This study is looking at whether testing pregnant women at the onset of labour for Group B Streptococcus (GBS) reduces the risk of infection in newborn babies.

5) STOPPIT3: This study aims to find out the effectiveness of antenatal corticosteroids given to women with a twin pregnancy prior to a planned birth of twins between 35-38+6 weeks gestation, in reducing the breathing difficulties of the babies.

6) iGBS3: A study looking into women’s natural immunity against GBS and to find how much antibody a woman needs to pass to her baby to protect from GBS disease. This may help in the development of a vaccine in the future.

7) CaPE: This study aims to evaluate the effectiveness of calcium supplementation alongside usual care of taking aspirin for prevention of pre-eclampsia and its complications in women at high risk of pre-eclampsia.

8) BiB4All: BiB4All is a data linkage cohort study of babies born in Bradford and their mothers. Every pregnant woman due to have their baby in Bradford will be invited to join the project by their midwife. If you would like to be a part of BiB4All or want to learn more, please visit https://www.babinetwork.co.uk/babi-sites/babi-bradford

Trials recently closed:

1) CHAPTER: Cohort study aimed to determine the prevalence, complications, health consequences and burden for those women who experience childbirth related perineal trauma.

2) WILL: This trial aimed to determine the optimal timing for delivery at term in women experiencing high blood pressure during pregnancy (excluding pre-eclampsia). Specifically, it compared the outcomes of birth at 38 to 38+3 weeks of pregnancy with those of receiving standard care at term.

3) CRAFT: This study aimed to evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour.

4) PURSUIT: A Randomised Controlled Trial of endoscopic and surgical treatment to gain a better understanding of recurrent stress urinary incontinence treatment in women.

5) LAVA: The study aimed to determine the clinical and cost-effectiveness of laparoscopic hysterectomy compared to open abdominal hysterectomy for women with a benign gynaecological condition.

6) ObsQoR: This study examined the correlation between the ‘Quality of Recovery from Obstetric Anaesthesia’ (ObsQoR) scoring tool and critical outcomes such as the duration of hospital stay and rates of readmission.

7) RECOVERY: This study explored potential treatment options for patients diagnosed with Covid-19 (SARS-CoV-2). Eligibility criteria for participation included pregnant women and those who had recently given birth and were admitted to the hospital due to Covid-19.

8) UKOSS: A national registry for pregnant women hospitalized with Covid-19 focused on key aspects: (i) assessing maternal and infant outcomes from Covid-19 during pregnancy, (ii) analysing the characteristics of these women and their influence on disease outcomes, and (iii) exploring how treatment for Covid-19 in pregnancy affects both mother and infant.

9) ISARIC: Gathered information from people receiving care in hospital for Covid-19, including pregnant women, to enable us to understand the clinical characteristics of people admitted to hospital with Covid-19 infection, this will help inform the research and public health responses to the virus.

10) Cancer Research UK study: Investigated the effects of maternal exposure to carcinogens, toxicants and nicotine during pregnancy, among e-cigarette users, smokers, nicotine replacement therapy users and women that have never used nicotine or tobacco products.

11) PREP: This study investigated the longer-term effectiveness, specifically at the end of pregnancy, of electronic cigarettes (EC) in comparison to nicotine transdermal patches for assisting pregnant women who smoke in their efforts to quit smoking.

12) C-Stich: focused on women perceived to have a weakened cervix and offered a cervical suture, assessing the impact of using varying types of cervical suture material – specifically, a monofilament suture versus a braided suture—in preventing pregnancy loss (such as miscarriage, stillbirth, and neonatal death within the first week of life) and evaluating neonatal mortality up to one month after birth.

Research conducted by Bradford Researchers:

We have undertaken research in several important areas including:

1) Hypertension in pregnancy: investigated blood pressure trajectories and reference ranges among Pakistani and British women enrolled in the Born in Bradford cohort study. Additionally, it explored clinicians’ adherence to the NICE (National Institute for Health and Care Excellence) recommendations for hypertension in pregnancy.

• Farrar, D., Tuffnell, D. & Sheldon, T.A. An evaluation of the influence of the publication of the UK National Institute for health and Care Excellence’s guidance on hypertension in pregnancy: a retrospective analysis of clinical practice. BMC Pregnancy Childbirth 20, 101 (2020). https://doi.org/10.1186/s12884-020-2780-y

• Farrar D, Santorelli G, Lawlor DA, Tuffnell D, Sheldon TA, West J, Macdonald-Wallis C. Blood pressure change across pregnancy in white British and Pakistani women: analysis of data from the Born in Bradford cohort. Sci Rep. 2019 Sep 13; 9(1):13199. doi: 10.1038/s41598-019-49722-9

• Santorelli G, Lawlor DA, West J, Tuffnell D, Farrar D. Population reference and healthy standard blood pressure range charts in pregnancy: findings from the Born in Bradford cohort study. Sci Rep. 2019 Dec 11; 9(1):18847. doi: 10.1038/s41598-019-55324-2.

2) The third stage of labour: investigated the effect of different timings of umbilical cord clamping on the volume of blood transfused at term birth.

• http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.2010.02781.x/epdf

3) Gestational diabetes:

• Farrar D, Simmonds M, Griffin S, Duarte A, Lawlor DA, Sculpher M, et al. The identification and treatment of women with hyperglycaemia in pregnancy: an analysis of individual participant data, systematic reviews, meta-analyses and an economic evaluation. Health Technol Assess 2016;20(86)

• Farrar, D., Simmonds, M., Bryant, M., Sheldon, T. A., Tuffnell, D., Golder, S., Dunne, F., & Lawlor, D. A. (2016, September 13). Hyperglycaemia and risk of adverse perinatal outcomes: Systematic Review and meta-analysis. The BMJ. https://www.bmj.com/content/354/bmj.i4694/related

• Farrar D, Fairley L, Santorelli G, Tuffnell D, Sheldon TA, Wright J, van Overveld L, Lawlor DA. Association between hyperglycaemia and adverse perinatal outcomes in south Asian and white British women: analysis of data from the Born in Bradford cohort. Lancet Diabetes Endocrinol. 2015 Oct; 3(10):795-804. doi:10.1016/S2213-8587(15)00255-7

Historical Research:

1) ANODE: The trial examined antibiotics’ efficacy for women undergoing forceps or ventouse births, randomizing them into groups receiving a placebo or antibiotics. Results showed a nearly 50% decrease in postnatal infections and a 56% reduction in systemic infections. Overall antibiotic use dropped by 17%, yielding an average cost saving of £56 per woman.

2) PITCHES: Ursodeoxycholic acid, a standard treatment for Intrahepatic Cholestasis of Pregnancy, was compared to a placebo in the PITCHES Trial to evaluate outcomes for mothers and babies. The trial revealed that the medication did not significantly improve outcomes, such as reducing itching or bile acid levels. While the study clarified the importance of specific bile acid levels in diagnosis and treatment, further research is required to find an effective medication for Intrahepatic Cholestasis of Pregnancy.

3) PARROT: The Parrot Trial evaluated whether placental growth factor, a placental biomarker found in maternal blood during pregnancy, could diagnose pre-eclampsia more effectively than current methods. Pre-eclampsia poses risks like seizures, liver and kidney damage, and stroke in mothers, and restricted growth or stillbirth in babies. The trial concluded that this biomarker enables earlier diagnosis and treatment initiation compared to existing diagnostic techniques.

4) BUMPES: The Bumpes study investigated if first-time birthing women with a low-dose epidural have a higher chance of spontaneous vaginal birth without forceps or ventouse when upright versus lying on their side during the second stage of labour. Results showed that being upright actually decreased the likelihood of spontaneous vaginal birth. There was no difference in labour care satisfaction between the two groups. Given the evidence, midwives are advised to encourage women with a low-dose epidural to lie on their side during the second stage of labour if comfortable.

5) The Respite study: The study compared labour pain relief using Pethidine versus Remifentanil, focusing on the rate of epidural requests. It found that patient-controlled remifentanil, administered through a pump, significantly reduced the need for epidurals by half. Additionally, the remifentanil group experienced fewer instrumental deliveries (15% vs 26%) and no increase in caesarean rates, with women reporting higher satisfaction with pain management when using remifentanil.

6) PHOENIX: A multi-centre randomised trial, comparing early delivery with expectant management (waiting until 37 weeks unless earlier delivery is clinically necessary) in women with pre-eclampsia at 34-36+6 weeks gestation. Women in the early delivery group experienced fewer health issues including very high blood pressure and had higher rates of spontaneous vaginal births than the expectant management group. However, their babies were more likely to be admitted to special care due to prematurity, though without an overall increase in ill-health.

7) MINESS: The MINESS study compared sleep practices between women who experienced stillbirth after 28 weeks and those with ongoing pregnancies at a similar gestation. It found that women in their third trimester who slept on their backs had at least twice the risk of stillbirth compared to those who slept on their left side. This led to Tommy’s #sleeponside campaign, advising pregnant women to sleep on their left side, but not to worry if they wake up on their back, instead to simply turn back onto their side.

8) MERIDIAN: The study focused on women whose fetus had brain abnormalities detected by ultrasound at 18 weeks gestation or later, offering them an MRI scan. The MRI showed a diagnostic accuracy of 93%, compared to ultrasound’s 68%, providing additional information in 50% of cases and altering the prognosis in 20% of cases. Women found MRI acceptable, leading to the current practice of offering MRI scans when fetal brain abnormalities are detected, thereby enhancing care planning with more information.