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The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles

This study aims to make ultrasound scans better at identifying a condition called a hydatidiform (say: high-DAH-tid-ih-form) mole, sometimes called a molar pregnancy, especially when someone is having an early miscarriage. A molar pregnancy is a rare problem where a baby doesn't develop properly. Researchers want to find the best ultrasound signs to tell the difference between a molar pregnancy and a regular miscarriage. This will help doctors provide clearer advice and the best care for women. The study involves looking at ultrasound results and tissue samples to compare them.

At a glance

Status
Active not recruiting
Sponsor
King's College Hospital NHS Trust
Enrolment target
500
Start
19 Oct 2021
Estimated completion
30 Sep 2024

What is this study about?

Imagine you're going through the tough experience of an early miscarriage, which means losing a pregnancy very early on. Sometimes, during this time, doctors need to check for a rare condition called a hydatidiform (say: high-DAH-tid-ih-form) mole, or molar pregnancy. This isn't a normal pregnancy; it's when something goes wrong at the very start where a baby doesn't form correctly.

This study is trying to make it easier and more accurate for doctors to spot these molar pregnancies using ultrasound scans. They want to find out which specific things they see on an ultrasound scan are the best clues that someone might have a molar pregnancy, rather than a more typical early miscarriage. Getting this diagnosis right quickly is really important because it helps doctors give you the most suitable advice and care.

By comparing what they see on the ultrasound with results from any tissue samples taken, the researchers hope to improve how doctors diagnose this condition. This means that if you are experiencing an early pregnancy loss, doctors will be better able to tell what's happening and guide you through the process with the right support.

Key takeaways

  • This study aims to improve ultrasound diagnosis of molar pregnancies during early miscarriage.
  • It helps doctors better understand what they see on scans.
  • Participation involves an ultrasound scan and potentially tissue testing and a blood test.
  • It could lead to faster, more accurate diagnoses for women in the future.
  • Your care will be closely monitored by specialists.
  • You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for women who are less than 16 weeks pregnant based on their last period or an ultrasound scan. You would be considered if your ultrasound shows that the early pregnancy has stopped developing, or if you are having an incomplete miscarriage, or if doctors suspect you might have a molar pregnancy.

However, you can't join if you decline to take part or don't want to have a special type of ultrasound scan called a transvaginal scan. You also can't join if you're carrying more than one baby (like twins), if the pregnancy is outside the womb (called an ectopic pregnancy), or if they can't quite locate the pregnancy. Lastly, you need to be able to understand English well enough to understand what the study involves and agree to take part.

Quick self-check
  • Are you less than 16 weeks pregnant?
  • Is your scan showing an early miscarriage or a suspected molar pregnancy?
  • Are you able to understand and agree to take part in English?
  • Is this a single pregnancy (not twins or more)?
  • Is the pregnancy inside the womb (not ectopic)?
  • Are you happy to have a transvaginal ultrasound scan?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, a specialist gynaecologist who is part of the research team or your usual care team will perform an ultrasound scan. They will specifically look for certain signs on the scan that could suggest a molar pregnancy. Based on these findings and national guidelines, you might be advised to have a surgical procedure to remove the pregnancy tissue. If you have this procedure, or if any tissue is available, it will be sent off for detailed testing (called histology) to confirm the diagnosis. If you don't have a surgical procedure, you'll be offered other standard care options. For those who don't have tissue sent for testing, the team will contact you about three weeks after your miscarriage to check that your pregnancy hormones have returned to normal using a blood test. This is to make sure there are no remaining pregnancy cells. The total duration of your direct involvement in terms of scans and follow-up would likely be over a few weeks.

Potential risks and benefits

Taking part could help improve how doctors diagnose molar pregnancies in the future, meaning other women might get faster and more accurate answers. For you personally, the main benefit is that your care (including ultrasound and any procedures) will be closely monitored, and any tissue samples will be carefully analysed. There are no direct personal risks beyond those normally associated with having an ultrasound scan or receiving care for a miscarriage. Your participation is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (2)

  • University College London Hospital
    London, United Kingdom
  • King's College Hospital
    London, United Kingdom

Common questions

What is a hydatidiform mole?

It's a rare pregnancy problem where a baby doesn't develop properly, and instead, unusual tissue grows in the womb.

Why is it important to diagnose a molar pregnancy?

Getting the correct diagnosis helps doctors give you the right advice and treatment plan, as the care for a molar pregnancy is different from a typical miscarriage.

Will I have extra tests if I join?

You will have an ultrasound scan as part of your care. If you have a procedure, tissue will be sent for testing. You might also have a blood test to check pregnancy hormone levels later on.

Will my information be kept private?

Yes, all your personal and medical information collected for the study will be kept confidential and handled according to strict privacy rules.

What if I change my mind about taking part?

You can leave the study at any time without having to give a reason, and it won't affect the medical care you receive.

How to find out more

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

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