Research is used to build new knowledge, improve current care and develop new treatments. The National Institute for Health Research Clinical Research Network (often referred to as CRN) provide the infrastructure that allows high-quality clinical research to take place in the NHS.

All clinical research has to be approved by an independent research ethics committee - the Medicines and Healthcare Products Regulatory Agency (MHRA). This safeguards the rights and welfare of research participants as well as making sure that high quality research is carried out. All research is voluntary and participants are free to withdraw at any time.

The Women’s Health department at UCLH are committed to improving outcomes for women and babies by improving care, diagnosis and treatment within obstetrics and gynaecology. A small team of research midwives and nurses work on an extensive portfolio of CRN funded research studies that cover specialised areas including maternity, gynaecology, neonatal care, fertility, genetics, miscarriage, urogynaecology and cancer.

UCLH is a large teaching hospital and has many research projects underway at any one time. Whilst under our care you are likely to be invited to participate in a research project by healthcare professionals. This may be one of our consultants, nurses or midwives.

Alternatively, if you are interested in volunteering for any of our studies or just would like to have some more information please contact us.

In the unlikely event you encounter any problems or have any concerns about any of our research activity, please contact any of the following:

Current research studies

Aim

To measure efficacy and safety of M281 in patients with Haemolytic Disease of the Fetus and Newborn (HDFN)

Recruitment

Patient with an obstetrical history of severe fetal anemia, hydrops, or stillbirth related to HDFN at ≤24 weeks gestation, have anti-D or anti-Kell IgG alloantibody titers consistent with disease, and be pregnant with an antigen-positive fetus. The study will include approximately 15 eligible patients and their offspring.

Aim

  1. CRAFT-OBS: To assess the risk of preterm birth or late miscarriage in women following an in labour caesarean section
  2. CRAFT-RCT: To assess if cervical cerclage reduces preterm birth in pregnant women with a short cervix following a previous in labour caesarean section
  3. CRAFT-IMG: To assess if alterations in MRI parameters or ultrasound characteristics occurs in women who undergo a late miscarriage or preterm birth following an in labour caesarean section

Recruitment

  1. CRAFT-OBS: pregnant women with 14+0-23+6 week with previous history of caesarean section in labour
  2. CRAFT-RCT: pregnant women with a previous history of caesarean section carried out at full dilatation and a short cervix (≤25mm) in current pregnancy
  3. CRAFT-IMG: pregnant women with a previous history of caesarean section carried out at full dilatation (30 women with cervix >25mm; 30 CRAFT-RCT participants)

Aim:

Investigate the role of T-regulatory (Treg) cell in maintaining a healthy pregnancy and influencing the development of pre-eclampsia.

Recruitment:

All women in their first ongoing pregnancy

Aim:

The primary objective is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).

Recruitment:

Patients who are pregnant to a gestational age (GA) of ≥8 weeks will be screened for inclusion during the current pregnancy. To be eligible for the study, patients must have an obstetrical history of severe fetal anemia, hydrops, or stillbirth related to HDFN, have anti-D or anti-Kell immunoglobulin G (IgG) alloantibody titers consistent with disease, and be currently pregnant with an antigen-positive fetus.

Aim:

This is a cohort observational study to develop novel imaging approaches to optimise imaging of different fetal structures and pregnancy tissue such as placenta, to gain additional information on the diagnostic and prognostic ability of ultrasound imaging and CCTG at different gestational ages & to gain additional information of the natural history of uncomplicated and complicated pregnancies.

Recruitment:

Women who have ultrasound imaging or CCTG monitoring at UCLH Integrated Antenatal Service will be eligible to be invited to participate. This includes women with low-risk pregnancies, and those with a pregnancy complication, for example, a congenital abnormality or preeclampsia.

Aim:

  • Establishing a registry of all UK twin pregnancies complicated by Twin to twin transfusion syndrome (TTTS) to answer uncertainties regarding the treatment and management.

Recruitment:

  • All complicated multiple pregnancies, uncomplicated monochorionic twin pregnancies, Triplet pregnancies and any multiple pregnancy (twin or triplet) complicated by TTTS.

Aim

  • To understand the means by which vaginal bacteria are involved in preterm birth.

Recruitment

  • Uncomplicated pregnant women, women at risk of pre-term labour, women who present with threatened pre-term labour and women up to 37 weeks gestation who present with ruptured membranes and are not in labour.

Aim

  • To understand the means by which vaginal bacteria are involved in preterm birth.

Recruitment

  • Uncomplicated pregnant women, women at risk of pre-term labour, women who present with threatened pre-term labour and women up to 37 weeks gestation who present with ruptured membranes and are not in labour.

Aim

  • Qualitative in-depth interviews with women and their partners concerning the acceptability of fetal surgery as part of the GIFT-Surg Programme.

Recruitment

  • Women with a singleton pregnancy that are eligible for fetal surgical intervention.

Aim

  • To create an adequately powered, detailed observational resource for the study of the environmental and genetic determinants of cleft lip/ palate, and the outcomes for patients and families affected by cleft lip/ palate

Recruitment

  • All children diagnosed (antenatally or postnatally) with a cleft and their families will be eligible to participate.

Aim:

To find out whether it is possible to grow stem cells from amniotic fluid, placental tissue and fetal fluid, and whether proteins found in the fluid can be used to indicate long term outcome for problems such as kidney disease.

Recruitment:

Two groups of women are eligible to take part in this study:

  1. women having amniocentesis or chorionic villus sampling (CVS), fetal blood or urine sampling for prenatal diagnosis are eligible to participate in the study.
  2. women attending UCLH to give birth to their baby.

Aim:

To improve the quality of imaging from Magnetic Resonance Imaging (MRI) and ultrasound and use these to develop low risk techniques for diagnosis, treatment and therapy for a range of dangerous conditions of the baby during pregnancy.

Recruitment:

Pregnant women recommended to have a fetal MRI due to fetal abnormality or pregnancy complications.

For more information visit: http://www.gift-surg.ac.uk/

Aim:

To look at new methods of detecting problems in pregnancy, in the hope of developing earlier and safer ways of identifying genetic conditions. Research has shown that a pregnant mother has some of her baby’s DNA and other substances in her own blood, so a simple blood sample from the mother can help us to detect any genetic conditions or chromosomal problems in the unborn baby.

Recruitment:

Women with normal and complicated pregnancies are asked to donate a blood sample of 20-30mls. In addition to this, where it is possible, we are also asking partners to donate about 10mls of their blood, so we can better define the baby’s DNA from the mother’s.

For more information visit: http://www.rapid.nhs.uk/

Aim:

To investigate how bacteria in the vagina and urine may help current tools (e.g. cervical length and fetal fibronectin) to best predict preterm birth in twins. We specifically aim to investigate twin pregnancies undergoing an intervention such as fetal laser surgery, as well as those undergoing a cervical cerclage.

Recruitment:

  • Uncomplicated singleton and twin pregnancy
  • Singleton pregnancy have had a prior spontaneous PTB before 34 weeks
  • Singleton or twin pregnancy at risk of preterm birth, requiring a clinically indicated cervical cerclage
  • Monochorionic twin pregnancy identified to have twin-twin transfusion syndrome (TTTS) or selective fetal growth restriction (sFGR) requiring fetoscopic

Aim:

  • To compare carboprost with oxytocin as initial treatments for women with clinically.
  • To assess the relative cost-effectiveness of the use of carboprost and oxytocin as initial treatments for women with clinically diagnosed PPH.
  • To explore the views of participants and their carers about their experiences of the two treatments and the consent process.

Recruitment:

  • ≥ 16 years of age
  • Requirement for medical treatment for primary PPH

Aim:

To establish the optimum method of timing delivery in late-preterm fetal growth restriction.

Recruitment:

  • Women ≥ 18 years old
  • pregnant with singleton non-anomalous fetuses
  • between 32+0 and 36+6 weeks of gestation
  • estimated fetal weight or abdominal circumference <10th percentile OR decreased by
  • 50 percentiles since an ultrasound scan at 18+0-32+0 weeks and:
  • cerebral redistribution defined as UCR >1.0 (32+0-33+6 weeks) or >0.8 (34+0-36+6 weeks) repeated within 2-24 hours
  • normal STV on cCTG (4.5msec or above)

This study is now closed for recruitment.

Aim:

  • To compare an investigational COVID vaccine against a placebo  to see if the study vaccine produces antibodies in expectant mothers and their babies once born and prevents COVID-19 in expectant mothers.
  • To help collect safety data on the study vaccine.

Recruitment:

  • Healthy women over 18 years old who are pregnant and expecting one child.
  • Participants should be about 24-36 weeks (6-8 months) pregnant when they receive the study injection
  • Should not have been previously diagnosed with COVID-19.

Aim:

To identify women who may be genetically programmed to be more likely to have a fever if they choose an epidural during labour.

Recruitment:

Women who are over 18 years of any gestational age with a singleton or twin pregnancy that are requesting an epidural for labour analgesia.

Aim

To explore how rapid fetal exome sequencing is delivered within the North Thames Genomic Laboratory Hub, and what challenges exist.

Recruitment

Women and their partners attending an appointment in the Fetal Medicine Unit because of an unexpected finding picked up in their pregnancy who have been/ are being offered rapid genetic diagnosis using exome sequencing during pregnancy.

Aim

Improve our knowledge and understanding of the caesarean section scar effect, by assessing the healing of the scar using ultrasound imaging. To compare the imaging findings with future pregnancy outcomes.

Recruitment

Women over 18 years old with a previous emergency lower segment caesarean section.

Aim

Recruitment

To determine if emergency cervical cerclage (operation to tie the neck of the womb closed when it has started to open too early in pregnancy) can help prevent pregnancy loss, reduce preterm birth and is safe for mothers and babies,

Pregnant women 16 years or older between 16 and 28 weeks of pregnancy who have an open cervix (neck of the womb) and the bag of eaters around baby is visible.

 

Aim >strong>Recruitment

In pregnant women with high blood pressure who have been pregnant for at least 36 to 37 weeks, is planned early term birth between 38+0 and 38+3 weeks better for the mother and baby than waiting for at least 40 weeks.  

Pregnant women 16 years or older with a diagnosis of chronic or gestational hypertension and gestation age of 36+0 to 37+6 weeks.

Aim:  

  • To evaluate the introduction of a measure of pregnancy planning during routine antenatal care and identify services needed to support women with unplanned pregnancies to inform widespread implementation.  
  • To identify factors that act as barriers and facilitators to the introduction of the London Measure of Unplanned Pregnancy tool in routine antenatal care to inform future widespread implementation.  
  • To identify the needs of women and their families with an unplanned pregnancy to inform clinical service development to meet these needs.  

Recruitment:  

  • Women who completed the London Measure of Unplanned Pregnancy (LMUP) during booking appointment at UCLH.  
  • Midwives who do bookings at UCLH.  
  • 15 years old or older  

Aim:  

  • To collect tissue from a variety of developing fetal organs in the last two-thirds of pregnancy from women who decide to undergo a termination of pregnancy and who wish to undergo a clinical fetal post-mortem (PM) examination.  

Recruitment:  

  • ≥18 years old pregnant women who attend the Fetal Medicine Unit for concerns about a fetal abnormality where they decide to proceed to termination of pregnancy. 
  • Written informed consent obtained (sought after the clinical decision to TOP and signatures for termination are obtained).  
  • >14 weeks gestation live pregnancy shown by ultrasound scan.  
  • Known low risk for HIV, Hepatitis B and Hepatitis C infections.  

Aim:  

  • To examine the effects of COVID-19 on maternal, pregnancy and perinatal outcomes. 
  • To assess the effect modification of maternal vaccination status on these outcomes.  
  • To relate these results to the ecologically reported predominant SARS-CoV-2 variants in the participating geographical areas.

Recruitment:  

  • Women over 18 years old, who have delivered at UCLH with confirmed or suspected COVID-19 infection. We are also inviting women without confirmed or suspected COVID-19 infection to compare their outcomes. 

Women's Health Research PRES Data Report

Participants of research studies within the Women’s Health department at UCLH were asked to take part in the Patient Research Experience Survey (PRES), as a part of the wider NIHR patient satisfaction project. Results of this survey are detailed in this report.