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Are you less than 8 weeks’ pregnant?

 Join the OxLuPIn study!

Sign up today

The OxLuPIn study (Oxford Luteal Dysfunction and Placental Insufficiency) is looking for women aged 16 years or older, who are less than 8 weeks’ pregnant, to help us understand early pregnancy and how to better predict complications such as high blood pressure later on.

OxLuPIn aims to understand whether very early pregnancy scans and simple tests (blood, urine, and swabs) can help identify who may later develop high blood pressure conditions such as pre-eclampsia. Early detection of women who are high risk to develop high blood pressure in pregnancy could lead to better treatments to prevent this condition.

What does taking part involve?

If you join the study, you will be invited for:

1. Two early pregnancy scans

  • The first scan (before 8 weeks)  this is not part of routine NHS pregnancy care and is only available through the study.
  • The second scan (10–14 weeks)  this is around the same time as the NHS “dating scan”, but in the study we complete some additional ultrasound measurements that are not routinely performed.

2. A small blood sample, urine sample, and vaginal and rectal swabs at each research visit.

These visits help us understand how early pregnancy develops and how we might improve the prediction and prevention of pregnancy complications in the future.

Why take part?

Taking part will not directly affect your medical care, but:

  • You will have an extra early scan that is not routinely available on the NHS.
  • You will be contributing to research that may improve pregnancy care for women in the future.

Your participation is voluntary. All information is kept confidential, and you can withdraw at any time without affecting your care.

FAQs

Q: I don’t know how many weeks pregnant I am, can I still take part?

In order to take part in this study, you will need to be less than 8 weeks’ pregnant (i.e., up until you are 7 weeks and 6 days pregnant). If you are unsure of your dates, you can contact the research team and we will help you work this out for you and determine whether you fulfil the inclusion criteria.

 

Q. Are there any specific criteria to be able to take part?

Yes, in order to be able to take part in the trial you must meet the following criteria:

- Age 16 years or above

- Pregnancy up to 7 weeks and 6 days’ gestation (<8 weeks)

- Intention to deliver at Oxford University Hospitals

- Willing and able to give informed consent

 

Q. If I meet the requirements, are there any specific criteria which would mean I cannot take part?

The following list contains our study exclusion criteria:

- If you have vaginal bleeding when you come to have your scan

- If your scan shows a pregnancy or womb abnormality

- If you have conceived in any of the following ways: fresh in vitro fertilisation, donor egg in vitro fertilisation

- If you are currently taking part in any trials of medicinal products in pregnancy.

 

Q: Are there any possible advantages or disadvantages from taking part?

Advantages

The advantages of taking part will be limited to having two additional ultrasound scans in early pregnancy, which you would not routinely have on the NHS, and knowing that you are making a contribution to science and medicine. There will be no other medical benefit to you from participating in this research and it will not affect your standard of medical care.

Disadvantages

You may find answering some of the questions embarrassing or difficult. You are not obliged to answer anything which you are not comfortable with. There may be some discomfort and bruising when blood samples are taken, or when you have your internal ultrasound scans.

Our study participants will not be paid either, but they will be greatly appreciated, and they will be important in finding out more about how to predict the risk of preeclampsia in pregnancy. However, you will be able to claim for travel expenses from the study budget for any research-only study visits.  Parking at Rose Hill Community Early Pregnancy Assessment Unit is free of charge.

 

Q: I don’t live in Oxford, can I still take part?

This study is being conducted in women who intend to deliver at Oxford University Hospitals NHS Foundation Trust. This includes all our midwifery-led units. You can contact the study team to find out whether your planned place of delivery is eligible for participation in this study.

 

Q: I take medications for other health conditions. Is this a problem or can I still take part?

You can continue to take your regular medication whether prescribed or over the counter medicines. However, we cannot include you in the study if you are currently enrolled in other research studies and taking investigational drugs. If you are not sure if you are eligible for this study, please talk to us and we will be happy to advise. Please get in touch with by email on oxlupin@wrh.ox.ac.uk and we can discuss your individual circumstances.

 

Q: What if there is a problem?

If you take part in the study, then you will retain the same legal rights as any other patient within the National Health Service.

The University of Oxford, as Sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study. NHS indemnity operates in respect of any clinical treatment which is provided.

If you wish to complain about any aspect of the way in which you have been approached or treated during the course of this study, you should contact the study Chief Investigator Dr Pedro Melo on pedro.melo@wrh.ox.ac.uk; or you may contact the University of Oxford Research Governance, Ethics & Assurance (RGEA) at rgea.complaints@admin.ox.ac.uk..

The Oxford University Hospitals Trust Patient Liaison and Advice Service (PALS) is a confidential NHS service that can provide you with support for any complaints or queries you may have regarding the care you receive as an NHS patient PALS can be contacted on Tel: 01865 221473 or email: PALS@ouh.nhs.uk. Please note that PALS is unable to provide information specifically about this research study.

The team

  • Pedro Melo
    Pedro Melo

    Senior Fellow & Consultant Subspecialist in Reproductive Medicine

  • Krina Zondervan
    Krina Zondervan

    Head of Department, Professor of Reproductive & Genomic Epidemiology, Co-Director Endometriosis CaRe Centre.

How you can help

We are looking for volunteers to participate in this study. By joining, you will contribute to important research that could allow clinicians to identify pregnancies at increased risk of complications at a much earlier stage than is currently possible.

To volunteer or learn more about the OxLuPin study, please contact us (link below). 

Sign-up today

By volunteering in medical research, you contribute to advancements that can improve countless lives and become a part of groundbreaking discoveries. Your efforts can spark change and inspire others, creating a ripple effect of positive impact. - Professor Krina Zondervan, Head of Nuffield Dept. of Women's & Reproductive Health