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.
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
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.
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.
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.
Prestige Study
Spontaneous Preterm birth remains a major global concern, as it is associated with significant neonatal morbidity and mortality. Approximately 10% of global pregnancies are affected by preterm birth and this amounts to 53,000 cases each year in the UK, pregnancies are complicated by Preterm Birth. There is increasing evidence suggesting there could be a substantial genetic influence on spontaneous Preterm birth.
This study aims to use Whole Genome Sequencing to determine the intricate genetic factors linked to spontaneous Preterm Birth across diverse populations.
Participant engagement and enrolment process:
Have you had a spontaneous preterm birth?
You might be eligible to join the national PRESTIGE-PTB study, investigating genetic features of spontaneous preterm birth.
Eligible participants will be invited to donate a single blood sample.
To read more, visit https://www.imperial.ac.uk/metabolism-digestion-reproduction/research/reproductive-developmental-biology/tommys-national-centre-for-preterm-research-at-imperial/prestige-ptb.
If you would like to take part, discuss this with your midwife to be signposted to the maternity research team.