Warrington and Halton Hospitals

Reproductive Health Research


We are part of the North West Coast Local Research Network and participate in studies to promote medical research and improve care in the future for certain conditions. These studies are large studies involving many patients in many different hospitals. You may be asked if you wish to be part of a research study. This is entirely voluntary and you should not feel under any pressure to take part.


The ALIFE2 trial

The ALIFE2 trial is a research trial to investigate whether anti-coagulant (blood thinning) treatment reduces the risk of miscarriage in women with inherited thrombophilia (blood that has a tendency to clot more than normal).We are trying to understand the reasons for and improve treatment for women with recurrent miscarriage.

If you can answer yes to the three questions below you may be able to take part the ALIFE2 trial.

1. Have you had two or more miscarriages?

2. Are you aged 18 to 42 years?

3. Are you trying for a baby but are not pregnant?

If you were to take part in this trial you will be randomly assigned toeither the trial treatment or standard care.

What do I have to do if I am interested?

If you wish to participate or would like more information please contact the research midwives, Rachel and Lindsay on:

01925 275211 / 01925 275514

This project was funded by the National Institute for Health Research, Research for Patient Benefit –

RfPB (project number PB-PG-101332011).


C-STITCH

CERCLAGE SUTURE TYPE FOR AN INSUFFICIENT CERVIX AND ITS EFFECT ON HEALTH OUTCOMES

  • There are two types of threads commonly used for cervical stitches (single strand or woven).
  • It is not yet known which thread is better.
  • This hospital is therefore taking part in a study called C-STITCH, which will tell us which thread is best and will hopefully reduce the number of babies that are born too soon.

For more information, contact the Warrington research midwives or email: stitch@trials.bham.ac.uk


PRISM

The PRISM trial is an important research study which is looking at whether progesterone can prevent miscarriage in women with early pregnancy bleeding. The trial is currently recruiting patients at 45 hospitals around the UK, including Warrington Hospital. At the end of April 2016, 1721 women had agreed to take part in the study.

PRISM is a randomised, double-blind, placebo-controlled trial:

Randomised: The women who take part will be given either the treatment drug (progesterone) or a placebo – a dummy drug that has no active ingredients. A computer makes the selection so it’s completely random.

Double-blind: The women in the study won’t be told whether they are taking the active medicine or the placebo – and neither will their doctors. So both are blinded to this information.

Placebo-controlled: Half the women in the study will have the active medicine and half (the controls) will have the placebo. The medicine that they receive will look exactly the same to them and their doctors, but a completely separate group will keep a record of which women have progesterone and which have the placebo.

For further information please visit the Miscarriage Association’s website:

http://www.miscarriageassociation.org.uk/information/research/the-prism-trial/

 


Phase III trial in IntrahepaTic CHolestasis of pregnancy (ICP) to Evaluate urSodeoxycholic Acid (UDCA) in improving perinatal outcomes

Intrahepatic cholestasis of pregnancy (ICP) or obstetric cholestasis (OC) is a liver disorder which occurs during pregnancy. It affects 1 in 150 pregnancies each year in the UK.

At the moment not all women in the UK receive the same treatment for ICP: some doctors prescribe UCDA and some do not. This is because doctors haven’t got absolute proof to be sure of the best treatment to use. We need a large clinical study to see whether UCDA helps protect babies or not. At the end of the study, we hope to be able to give clear and definitive guidance for doctors treating this condition.

For more information, click on the links or contact the Warrington research midwives.

www.npeu.ox.ac.uk/pitches

www.icpsupport.org

 


RAPID and PAGE

The aim of this study is to develop earlier and safer ways of detecting problems in pregnancy. Research has shown that it may be possible to use a simple blood test taken from the mother early in pregnancy to gather information about the health of the baby and predict certain complications of pregnancy. This will do this by testing the baby’s genes and other substances in the maternal blood.

PAGE involves a more detailed look at the baby's DNA - capable of picking up smaller changes.


GOT-IT Trial: A pragmatic group sequential placebo controlled randomised trial to determine the effectiveness of Glyceryl trinitrate for retained placenta.

Eleven thousand women a year in the UK have a retained placenta. At the moment the standard treatment for this is a procedure called manual removal of the placenta which involves an anaesthetic – either spinal or general. In this study we hope to prove that a drug called Glyceryl trinitrate (GTN) can be used to help deliver the placenta without the need for surgery.

Contact details for further information about this study:

Fiona Denison (Chief Investigator)
Tel: 0131 242 6449; Email: Fiona.Denison@ed.ac.uk
 
Susan Morrow (GOT-IT Trial Manager)
Tel: 0131 242 6753; Email: Susan.Morrow@ed.ac.uk
 

The study is funded by the National Institute for Health Research Health Technology Assessment Programme.


Closed Studies

We have taken part in the following studies are currently awaiting the results:

  • FACT
  • NaME
  • MiNNESS
  • TABLET
  • DAPPA
  • BUMPES
  • INFANT
  • PREP
  • EMPIRE

To find out more about them click here.


Local contacts for the studies in Warrington

Rita Arya Principal Investigator
Tel: 01925 275211

Lindsay Roughley Research Midwife
Tel: 01925 275211
Email: lindsay.roughley@whh.nhs.uk

Rachel Crone Research Midwife
Tel: 01925 275514
Email: Rachel.crone@whh.nhs.uk

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