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Contact Information:

Prof Gordon Smith
+44 (0) 1223 336871
gcss2@cam.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Pregnancy outcome prediction study 2
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Pregnancy outcome prediction study 2

Recruiting

Open to: Female

Age: Adult

Cambridge

Medical Conditions

Pre-eclampsia and fetal growth restriction

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Screening for pregnancy complications around delivery has not changed very much over the last 30 years. Moreover, we know that the methods currently employed, such as measuring the size of the “bump” with a tape measure, do not perform well

The aims of this trial are:
1. To determine whether a new approach, using ultrasound and blood tests, is effective at picking up high risk pregnancies, and
2. Whether intervening in the pregnancy, based on the result, reduces the risk. Intervention will consist primarily of the offer of earlier delivery by induction of labour

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jan 2020 30 Nov 2026

We will obtain blood at around 12, 20, 28 and 36 weeks of gestation from the women and blood from the father of the baby (if present and consents) at one of these visits. We will also obtain samples at the time of birth, including placenta, membranes and blood from the umbilical cord. We will collect data from the participants through a questionnaire and by performing ultrasound scans at around 20, 28 and 36 weeks. We will link the research data to the woman's and baby's clinical records. The data and biological samples will provide a resource to develop and validate predictive tests for adverse pregnancy outcome. However, in addition to this, we will also perform a randomised controlled trial. Using data from the Pregnancy Outcome Prediction study, we have developed a test which identifies women at high risk of complications at around eight months of pregnancy (36 weeks). The blood sample, scan information and mother's characteristics will be used to identify women at high risk following the 36 week visit. These women will be randomised to have routine care (meaning that the high risk status will not be revealed) or to have the result revealed with the offer of intervention, principally, early delivery of the baby by induction of labour. The primary outcome of the trial is a composite of either preeclampsia (a pregnancy-specific complication resulting in high blood pressure and other problems) in the mother or growth restriction of the baby


Women with a singleton pregnancy at the time of their dating ultrasound scan who have not had any previous births

You can take part if:



You may not be able to take part if:


Does not meet inclusion criteria


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Rosie Hospital
    Robinson Way
    Cambridge
    CB2 0SW

Participating involves some additional blood tests and these can cause mild discomfort and bruising. One benefit of participating is that we will reveal some scan information when it shows that there is a major problem. For example all women in the study will be told if there baby is in a breech presentation at 36 weeks. This allows time to try and turn the baby or to plan a caesarean delivery. In relation to the women who screen high risk, those who are randomised to having the result revealed and receiving intervention may either experience risks or benefits. We do not know the balance and this is the reason for doing the research. Women who screen high risk where the result is incorrect (i.e. they would have had a normal outcome if left alone) may experience an unnecessary intervention, specifically early induction of labour. However, women who screen high risk where the result is correct may benefit by avoiding complications of pregnancy through earlier delivery, before the complication can happen

Prof Gordon Smith
+44 (0) 1223 336871
gcss2@cam.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Cambridge University Hospitals NHS Foundation Trust; Cambridge University and funded by Wellcome Trust.



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Read full details for Trial ID: ISRCTN12181427
Last updated 22 November 2024

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