We are committed to improve the care we provide to the women/birthing people and their families, which is why we offer our service users the chance to get involved in clinical research studies. Below is a list of some of the research studies we offer.
If you are interested on participation or getting more information from any of the studies, contact your health care professional.
Basildon Hospital
1. Imperial College London- Early versus late monitoring among women and birthing people with a history of gestational diabetes – Observational multicentre cohort study.
Profound biochemical and physiological changes are observed throughout the pregnancy, and some of the hormonal changes can cause the body not to be able to produce enough insulin or their body is more resistant to insulin causing blood levels to remain high and in pregnancy this is called gestational diabetes.
Although, NICE guidance suggests that we should offer the pregnant person/women with a history of GDM with early monitoring of blood glucose testing with a full oral glucose tolerance test at 16-28 weeks, the reality is that the practice across the UK vary, and it is not clear which approach is more effective at reducing the short- and long-term risks of GDM in pregnancy.
The aim of the study is to study two groups of women/birthing people: early blood glucose monitoring and later glucose monitoring and determine, if there is a difference in short- and long-term outcomes.
Taking part in the study we do not expect you to change what you do during the pregnancy. If you decide to participate, we will continue to observe and after birth we collect the data of your pregnancy, birth and baby and contact 6weeks postnatally. All the information will be pseudonymised.
For further information please contact the diabetic midwife.
Broomfield Hospital
1. OBS UK
Every year 50,000 women and birthing people in the UK lose 1 litre of blood or more during childbirth with 28% requiring a blood transfusion. Bleeding is the leading cause of maternal death and there have been no improvements in maternal morbidity due to postpartum haemorrhage (PPH) in the last 15 years. PPH can have long term psychological consequences for women/birthing people and their birth partners.
Following on from a promising pilot study across 12 sites in Wales, OBS UK aims to implement an obstetric bleeding strategy (OBS) PPH care bundle to evaluate a new way of managing heavy bleeding during childbirth.
Anyone who has a baby at Broomfield Hospital in Mid Essex will be included in a research project to improve the quality of care. You’ll always have a choice about what care you accept or refuse, and it’s a good idea to talk this over with your midwife or healthcare provider.
This care project includes four main steps:
- Checking for bleeding risks: When someone is admitted or goes into labour, we’ll check if they’re at higher risk for heavy bleeding.
- Measuring blood loss: After every birth, including home births, all blood loss will be carefully measured.
- Acting quickly if needed: If bleeding reaches certain levels, or if we’re concerned, the right team will be called in to help.
- Special blood tests: If someone loses 1 litre of blood and the bleeding continues, a quick blood test will be offered along with regular lab tests. This will be repeated after each additional 500ml of blood loss or if blood products are given. This test is only available in the labour ward, so anyone giving birth outside of the ward would be offered a transfer to Broomfield Hospital if heavy bleeding is detected or if there are other concerns.
The care team will review the results to decide if blood products are needed to help with clotting. This may not be suitable for everyone, such as people with certain bleeding disorders like Immune thrombocytopenia (ITP).
Please talk to your midwife to see if a referral to a specialist is needed for more advice.
Women and birthing people may be approached by the research team to discuss taking part in the psychology and cost effectiveness sub studies. Further information can be found here: (www.obsuk.org).
Southend Hospital
1. LOCI Trial – Women/people diagnosed with polycystic ovary syndrome (PCOS)
Infertility affects one in six couples, with 25% of infertility being due to anovulation (not releasing eggs from the ovaries). Polycystic ovary syndrome (PCOS) is also very common; (approximately 10% of women of reproductive age in the UK have this condition) and it is responsible for 85% of anovulation. Invasive treatments, such as an operation called ovarian diathermy or In-vitro fertilisation (IVF), may overcome anovulation from PCOS, but are associated with significant risks and costs.
This trial is investigating the effectiveness of two different drugs (letrozole and clomifene) with metformin or placebo on fertility, in woman/people with anovulatory PCOS and infertility on live birth rate ≥34 weeks of gestation.
Recruitment eligibility:
- Women/people diagnosed with PCOS (according to Rotterdam criteria) and evidence of anovulation (irregular cycles lasting <21 or more than 35 days or less than 8 periods per year OR absence of raised serum progesterone greater than 20nmol/L 7 days prior to a period)
- Presentation with infertility or wishing to conceive.
- Male partner with normal sperm count (≥ 15 million) and progressive motility (≥32% in the last 3 years).
For more information about the trial, please visit the LOCI trial website: LOCI trial - University of Birmingham.
2. CaPE Trial
Calcium supplementation for prevention of pre-eclampsia in high-risk women/birhting people.
Pre-eclampsia complicates around 1 in 30 pregnancies every year in UK. The underlying cause of preeclampsia remains still unclear. It is thought to occur secondary to poor placentation and endothelial cell damage, resulting in widespread vasoconstriction, abnormal coagulation, and poor organ perfusion.
The aim of the CaPE trial is to find out whether taking calcium tablets, alongside usual antenatal care, reduces the risk of women developing pre-eclampsia.
Trial participants will be randomised to receive either an oral calcium supplement for 2gm per day plus usual care (including aspirin) or a placebo plus usual care (including aspirin), to be commenced anytime from 12- 22 weeks of gestation until delivery.
For any further information of the study please visit: The CaPE trial - University of Birmingham
3. ASPRE-T
Preeclampsia (PE) which results in premature birth is a serious complication of pregnancy and a major cause of short and long-term maternal and perinatal morbidity and mortality. This is a trial which is involving MCDA and DCDA twins, and the findings show that rate of PE is about 9% which is 3 times higher than in singleton pregnancies.
The aim of the study is to examine if the prophylactic use of low-dose aspirin from the first trimester of pregnancy in women/birthing people with twin pregnancy can reduce the incidence of PE.
This is a double-blind randomised placebo-controlled trial. The participant who meets the eligibility criteria will be offered the trial at the first hospital visit 11-13 weeks gestation in pregnancy.
For further information of the study please visit: aspre-t.org.
4. Imperial College London- Early versus late monitoring among women and birthing people with a history of gestational diabetes – Observational multicentre cohort study.
Profound biochemical and physiological changes are observed throughout the pregnancy, and some of the hormonal changes can cause the body not to be able to produce enough insulin or their body is more resistant to insulin causing blood levels to remain high and in pregnancy this is called gestational diabetes.
Although, NICE guidance suggests that we should offer the pregnant person/women with a history of GDM with early monitoring of blood glucose testing with a full oral glucose tolerance test at 16-28 weeks, the reality is that the practice across the UK vary, and it is not clear which approach is more effective at reducing the short- and long-term risks of GDM in pregnancy.
The aim of the study is to study two groups of women/birthing people: early blood glucose monitoring and later glucose monitoring and determine, if there is a difference in short- and long-term outcomes.
Taking part in the study we do not expect you to change what you do during the pregnancy. If you decide to participate, we will continue to observe and after birth we collect the data of your pregnancy, birth and baby and contact 6weeks postnatally. All the information will be pseudonymised.
For further information please contact the diabetic midwife.
5. SNAP2 study, University of Oxford- The aim of the study is to develop and test the clinical and cost-effectiveness of an intervention to support self-management of antihypertensive medication following a hypertensive pregnancy. The intervention aims to improve long-term blood pressure control and thereby reduce adverse cardiovascular outcomes and associated costs to the NHS.
Pregnant women and birthing individuals in the postnatal period who require antihypertensive treatment can participate in the study. The study consists of two arms:
- Intervention Arm: Blood pressure self-monitoring using a validated monitor and self-titration of antihypertensive therapy guided by a digital intervention overseen by clinicians.
- Control Arm: Usual care pathway provided by the trust.
For further information, please contact the maternity research team. Find more information about the SNAP2 study on the here: https://www.phctrials.ox.ac.uk/studies/snap2.