Not yet recruitingOBSERVATIONAL

Oxford Luteal Dysfunction and Placental Insufficiency Study

This study, called the 'Oxford Luteal Dysfunction and Placental Insufficiency Study,' focuses on pre-eclampsia, a serious high blood pressure condition that affects many pregnant women and can harm both mothers and babies. Researchers are trying to find out why some women develop pre-eclampsia and how to prevent it. They believe that a small gland in the ovary called the corpus luteum, which releases important hormones like progesterone in early pregnancy, plays a key role. If this gland doesn't work well, it might affect how the baby's support system (the placenta) attaches, which can lead to pre-eclampsia. This study will check ultrasound pictures of the corpus luteum and measure hormone levels in blood and urine to see if these can predict the risk of pre-eclampsia later in pregnancy.

At a glance

Status

Not yet recruiting

Sponsor

University of Oxford

Enrolment target

360

Start

01 May 2026

Estimated completion

01 Jan 2027

Pre-eclampsia

What is this study about?

You've probably heard that high blood pressure during pregnancy can be serious, and for about half of these women, it can lead to a condition called pre-eclampsia. This condition is a major concern worldwide for both mothers and babies. Scientists haven't fully understood why pre-eclampsia happens or how to prevent it, but they now think a big part of the puzzle relates to how the baby's support system, the placenta, attaches to the womb in the very early stages of pregnancy.

In the first eight weeks of pregnancy, a tiny gland in your ovary, called the corpus luteum, is really important. It releases hormones, like progesterone, which help the placenta attach properly. If these hormone levels are too low early on, it might increase the risk of problems like miscarriage and conditions later in pregnancy. Interestingly, studies have shown that giving progesterone to women at risk of miscarriage in early pregnancy might also reduce their chances of getting pre-eclampsia. This suggests just how vital the corpus luteum is for a healthy pregnancy.

Because of this, researchers for the Oxford Luteal Dysfunction and Placental Insufficiency Study want to find better ways to identify women whose corpus luteum might not be working perfectly. They plan to use ultrasound scans to look at the corpus luteum and measure hormone levels in blood and urine. By doing this, they hope to discover clues that could predict who might develop pre-eclampsia. Finding these clues could eventually lead to new ways to support the corpus luteum and help the placenta attach better, lowering the risk of serious problems like pre-eclampsia for many pregnant women.

Key takeaways

The study aims to understand pre-eclampsia, a serious high blood pressure condition in pregnancy.
It focuses on the role of the corpus luteum (a gland in the ovary) and its hormones in early pregnancy.
Researchers will use ultrasounds and blood/urine tests to try and predict pre-eclampsia.
This is an 'observational' study; no new treatments or medicines are involved.
Participation could help improve future prevention of pre-eclampsia for other women.
You must be under 8 weeks pregnant and planning to deliver at Oxford University Hospitals to join.

Who may be eligible?

This study is looking for pregnant women who are at least 16 years old. You would need to be very early in your pregnancy, specifically less than 8 completed weeks (up to 7 weeks and 6 days) when you first join.

We are interested in women who became pregnant in standard ways, such as naturally, through ovulation induction (where medication helps you ovulate), or with fertility treatments like intrauterine insemination (IUI) or natural cycle frozen embryo transfer. It's important that an early ultrasound scan confirms your pregnancy is healthy and developing inside the womb. Also, you should be planning to have your baby at one of the hospitals managed by Oxford University Hospitals.

However, some situations would mean you cannot join the study. This includes if you can't read or understand English, have any vaginal bleeding or signs of miscarriage when you first visit, or if you have an ectopic pregnancy (where the pregnancy isn't in the womb). You also can't join if you are expecting twins or more, have certain womb conditions like fibroids that might affect the pregnancy, or if you became pregnant through fresh IVF or donor egg IVF, or frozen embryo transfer where you used hormone medicines to prepare your womb.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Are you less than 8 weeks pregnant (7 weeks and 6 days or less)?
Is your pregnancy confirmed as healthy and inside the womb?
Are you planning to have your baby at Oxford University Hospitals?
Did you become pregnant naturally or through ovulation induction, IUI, or natural cycle frozen embryo transfer?
Can you read and understand English?

Answer every question to see your result.

What does participation involve?

This study does not involve any new treatments or medicines. It is an 'observational' study, meaning we will be collecting information and samples from you to understand more about pre-eclampsia. You won't be given any interventions. Your involvement will mostly happen during your regular early pregnancy care visits at Oxford University Hospitals. During these visits, we would ask to perform an ultrasound scan to look at your ovary and the corpus luteum, and we would also collect blood and urine samples to measure your hormone levels. These tests are in addition to your standard pregnancy care, but they are not expected to add significant extra time to your appointments. We would follow your pregnancy journey to see if there are any connections between what we observed early on and how your pregnancy progresses. The total duration of your participation would cover your pregnancy until delivery.

Potential risks and benefits

There are no direct personal benefits for participating in this particular study, as it's an observational study and doesn't involve any treatments. However, your involvement could greatly help future research, leading to a better understanding of pre-eclampsia and potentially new ways to prevent it for other pregnant women. The risks are very low; they mainly involve the discomfort of blood tests and the time taken for additional scans and sample collection. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oxford University Hospitals NHS Foundation Trust
Verified postcode
Oxford, United Kingdom

Common questions

What is pre-eclampsia?

Pre-eclampsia is a serious condition that can develop during pregnancy, usually after 20 weeks. It involves high blood pressure and can affect organs like the kidneys and liver, potentially harming both the mother and baby.

What is the 'corpus luteum'?

The corpus luteum is a temporary gland that forms in your ovary after you ovulate. In early pregnancy, it produces important hormones, especially progesterone, which help the pregnancy develop properly.

Will I receive any new medicine or treatment in this study?

No, this study is about observation. You will not receive any new medicines or treatments as part of this research. We are just collecting information to learn more.

How much extra time will this add to my appointments?

The study activities, like extra scans and blood/urine tests, will be scheduled alongside your routine early pregnancy appointments and should not add a significant amount of extra time.

What if I change my mind about participating?

You are free to leave the study at any point, and your decision will not affect the medical care you receive for your pregnancy.

How to find out more

Pedro Melo, MD PhD MRCOG

pedro.melo@wrh.ox.ac.uk 01865 221021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.