Find out about our current, on-going, reproductive health research trials

Reproductive health research trials

 

Trial: CONCEIVE - An investigation into changes occurring during a women’s pregnancy from pre-conception until after delivery

Research area

Reproductive health, maternal disease

Summary

The aim of this study is to investigate if birth defects during pregnancy are linked to pre-eclampsia or restricted growth of a baby.

Researchers will carry out non-invasive heart function and blood pressure tests on women before conception.

The women will then be monitored until after delivery, so that any subtle links between their pre-pregnant state and pregnancy outcomes can be established.

The findings of the study could help doctors identify women who are at risk of developing pre-eclampsia during pregnancy.
This study will require six hospital visits:

  • pre-conception
  • at 6 weeks
  • at 10 weeks
  • at 22 weeks
  • at 34 weeks
  • at 6 weeks post-partum

Who can take part?

Women aged between 18 and 44 years embarking upon their first pregnancy and trying to conceive for less than 11 months.

Study location

Queen Charlotte’s & Chelsea Hospital

Contact

Alice Gautreau, research midwife and Dr Lin Foo, clinical research fellow

Women’s Health Research Centre (WHRC)

Email: imperial.conceive@nhs.net

Phone: 020 3313 5281

 

Trial: Intrahepatic cholestasis and gestational diabetes mellitus during pregnancy

Research area

Reproductive health

Summary

This study will look into the causes of intrahepatic cholestasis of pregnancy (ICP), a liver condition where the normal flow of bile is reduced resulting in severe itching in the mother and a risk of premature delivery and stillbirth.

It will also look into the causes of gestational diabetes mellitus (GDM), a condition where women without previously diagnosed diabetes exhibit high blood glucose (blood sugar) levels during pregnancy.

Researchers behind the study will investigate the levels of lipids, glucose and hormones in women with ICP, GDM and other complications.

The team aims to gain further insights into causes of ICP and GDM which could help doctors to advise women on lifestyle choices during pregnancy such as diet.

Who can take part?

Cases:

Women aged between 16 and 70 years either:

  • pregnant with ICP defined as severe itching in pregnancy in association with blood levels of bile acids that are raised
    or
  • women who had ICP previously but are currently not pregnant.

Controls:

Women aged between 16 and 70 years either:

  • pregnant and not affected by ICP
    or
  • women who are currently not pregnant and had previous uncomplicated pregnancies

Study location

Imperial College London (Hammersmith Campus)

Contact

Jenny Chambers, clinical trials coordinator
Women’s Health Research Centre (WHRC)

Email: whrcenquiries@imperial.nhs.uk
Phone: 020 3313 5281

 

Trial: Preventing recurrent gestational diabetes mellitus (GDM) with early metformin intervention

Research area

Gestational diabetes, reproductive health

Summary

This study is designed to assess whether metformin can help prevent recurrent gestational diabetes mellitus (GDM) in women with pregnancies previously affected by this condition.

Women will be randomised to either metformin or placebo between 12 and 16 weeks gestation (once they have had their dating scan confirming a viable intra-uterine pregnancy).

Gestational diabetes is associated with increased risks for both mother and developing fetus with the former being more likely to develop pre-eclampsia, require a caesarean section and develop type 2 diabetes later in life.

It is therefore important to identify suitable GDM prevention strategies, particularly as GDM is occurring more frequently and a number of GDM pregnancies could have detrimental metabolic effects for the mother.

The principal ethical issues in this trial relate to the inclusion of pregnant women in this study and the use of metformin in non-licensed conditions.

Metformin is an insulin-sensitising agent widely used since the 1950s. Though not currently licensed in pregnancy, there is strong evidence demonstrating the safety of metformin in pregnancy. In the context of polycystic ovarian syndrome, metformin is used to stimulate ovulation illustrating the confidence that it is non-teratogenic (unlikely to disturb the development of an embryo or fetus).

In 2008, the National Institute of Clinical Excellence revised their guidelines relating to the management of diabetes in pregnancy saying that metformin can now be used as an alternative or in conjunction with insulin therapy both pre-conceptually and during pregnancy.

Who can take part?

  • Women with a confirmed singleton viable pregnancy
  • Between 8 and 22 weeks gestation History of a previous pregnancy complicated by gestational diabetes mellitus

Time commitments

With the exception of two visits (screening and randomisation) all study visits will be carried out in conjunction with routine antenatal attendances (on a two weekly basis at each of the 3 participating centres).

Contact

Rochan Agha-Jaffar, specialist registrar (SpR)
Email: r.agha-jaffar@imperial.ac.uk

 

Trial: EPOS - Early pregnancy events and outcomes

Research area

Reproductive health

Summary

The aim of the EPOS study is to investigate if women who experience pain and/or bleeding or other pregnancy symptoms in the first fourteen weeks of pregnancy may be more at risk of complications such as miscarriage, premature labour, placental problems or a small baby later in pregnancy.

Another aim of the study is to improve the prediction of pregnancy problems, such as miscarriage and premature delivery so that we can support a healthy pregnancy, mother and infant.

Who can take part?

Women in the first trimester of pregnancy aged between 1 and 50 years old.

Time commitments

Two to three hospital visits (in addition to your standard hospital visits).  Each visit will take approximately 30 minutes.

Study location

Queen Charlotte’s & Chelsea Hospital

Contact

Maria Pipi, research midwife and Alison Perry, midwife
Women’s Health Research Centre (WHRC)

Email: ICHC-tr.epos@nhs.net
Phone: 020 3313 5281

 

Trial: PRISM - The effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding

Research area

Reproductive health, recurrent miscarriage

Summary

The aim of the PRISM trial is to investigate whether progesterone drugs can prevent miscarriages in women with early pregnancy bleeding, a known sign of threatened miscarriage.

Who can take part?

Women aged between 16 and 39 years, with early pregnancy bleeding in the first 12 weeks of pregnancy.

Study location

St. Mary’s Hospital

Contact

Angela Brady, midwife
Women’s Health Research Centre (WHRC)

Email: angela.brady1@nhs.net
Phone: 020 3312 6483

 

Trial: VMET 2 - Vaginal microbiome (genetic material of the microorganisms) and metabolome (cell/tissue chemicals) in pregnancy

Research area

Reproductive health, premature

Summary

The aim of the study is to investigate the role of vaginal bacteria in premature labour.

Who can take part?

Women aged 18 and over can take part in one of the four groups:

  • Group 1:

    Uncomplicated pregnant women from the time of booking (8-12 weeks pregnant) 

  • Group 2:

    Women at risk of pre-term labour (patients referred to the prematurity clinic)

  • Group 3:

    Women who present with threatened pre-term labour (TPTL) with a positive fetal fibronectin test, without ruptured membranes

  • Group 4:

    Women up to 37 weeks gestation who present with ruptured membranes and are not in labour (PPROM)

Study location

Queen Charlotte’s & Chelsea Hospital

St. Mary’s Hospital

Contact

Jenny Troy, research midwife

Women’s Health Research Centre (WHRC)

Email: whrcenquiries@imperial.ac.uk

Phone: 020 3313 5281

 

Trial: The physiological effect of kisspeptin on reproductive hormones

Research area

Reproductive health 

Summary

We at Imperial College are interested in finding out the effects of hormones that control reproduction. We’re looking for healthy female volunteers aged 18-35 who have regular periods or irregular periods and are not on any contraceptive medicine, as well as healthy male volunteers aged 18-35 to participate in this trial. Volunteers will be screened for their suitability and if eligible will be invited to attend study visits, where regular blood tests will be taken. Expenses up to £200 per day will be paid.

Who can take part?

Healthy males aged 18-35 years who are not on medication, and healthy females aged 18-35 years who are not on medication (including hormonal contraception).

Time commitment

One whole day visit, and a single blood test on each of the following two mornings, every month for up to six months.

Study location

Hammersmith Hospital

Contact

Email: kisspeptin@imperial.ac.uk

Principal investigator

Professor Waljit Dhillo