TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
This research study aims to find the best time to treat a rare and serious issue in twin pregnancies called Twin Reversed Arterial Perfusion (TRAP) sequence. In TRAP sequence, one twin, which isn't developing properly, receives blood backward from the healthy twin, putting the healthy twin at risk. The study will compare two approaches: treating the TRAP sequence early, between 12 and 14 weeks of pregnancy, or treating it later, between 16 and 19 weeks. Women with this condition will be randomly assigned to either the early or late treatment group. Doctors will use special ultrasound techniques to stop the blood flow to the undeveloped twin. The goal is to see if early treatment leads to better outcomes for the healthy twin, like improving their chances of survival and healthy development.
At a glance
What is this study about?
This study is looking into a rare but serious condition that can happen in some twin pregnancies called Twin Reversed Arterial Perfusion (TRAP) sequence. In this condition, one twin doesn't develop properly and receives blood in the opposite direction from the other, healthy twin. This means the healthy twin, sometimes called the 'pump twin,' has to work extra hard to supply blood to both itself and the undeveloped twin, which can put the healthy twin's life at risk.
The main idea for this study is to figure out the best time to step in and treat this problem. Currently, doctors aren't sure if it's better to treat the TRAP sequence very early in the pregnancy (between 12 and 14 weeks) or a little later (between 16 and 19 weeks). The study aims to compare these two timings to see which one helps the healthy twin the most.
To do this, pregnant women diagnosed with TRAP sequence will be put into one of two groups by chance – like flipping a coin. One group will receive treatment early, and the other will receive it later. The treatment involves a minor procedure, guided by ultrasound, to stop the blood flow to the undeveloped twin. This takes the strain off the healthy twin. The doctors involved are carefully studying the outcomes to learn how to give the healthy twin the best possible chance.
Key takeaways
- The study compares early vs. late treatment for TRAP sequence.
- Goal is to improve outcomes for the healthy twin.
- Participation involves a minor ultrasound-guided procedure.
- Timing of treatment is decided by chance (randomly assigned).
- All procedures are done by experienced medical professionals.
- Your medical care will not be affected if you choose not to participate or withdraw.
Who may be eligible?
To be part of this study, you need to be at least 18 years old and pregnant with twins where one has TRAP sequence, diagnosed between 11 and a half and 13 and a half weeks. The healthy twin must appear normal on scans, and your pregnancy must be a specific type where both twins share a placenta but have their own amniotic sac. You'll also need to be able to understand and sign a consent form.
You wouldn't be able to join if you have a serious health problem that makes having the procedure risky, or if your womb is tilted in a way that makes the procedure difficult. Also, if you have severe obesity, fibroids in your womb, or if the undeveloped twin is hidden by your bowel or placenta, it might be too hard to carry out the treatment safely.
Other reasons you might not be eligible include if the healthy twin has a major problem that would need surgery or cause severe disability, or if the blood flow to the undeveloped twin has already stopped on its own, or if the healthy twin has sadly passed away already when the condition is first found.
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 at least 18 years old?
- Is your pregnancy a twin pregnancy with TRAP sequence, diagnosed between 11.5 and 13.5 weeks?
- Does your healthy twin appear normal on scans?
- Do you have good overall health without serious medical conditions?
- Is the undeveloped twin seen clearly on scans without being hidden?
What does participation involve?
If you choose to take part in this study, you would first sign a consent form. Then, you would be randomly assigned to either the 'early intervention' group (where treatment happens between 12-14 weeks of pregnancy) or the 'late intervention' group (where treatment happens between 16-19 weeks). This assignment is done by chance, similar to drawing straws.
The treatment itself is a minor procedure. It's done with local pain relief or light sedation, so you'll be comfortable but awake or very drowsy. A doctor who is experienced in these procedures will use ultrasound to guide a very thin needle into the undeveloped twin to stop its blood supply. This procedure usually happens within one week of you being assigned to a group.
After the procedure, you will have regular follow-up appointments with your doctors to monitor your pregnancy and the health of your baby. The study will continue to track your progress and your baby's health through to delivery and likely for a period after birth, to understand the long-term results of the intervention.
Potential risks and benefits
Locations (14)
- Children's Memorial Hermann HospitalVerified postcodeHouston, United States· Recruiting
- Universitätsklinik für Frauenheilkunde und GeburtshilfeVerified postcodeGraz, Austria· Recruiting
- Universitaire Ziekenhuizen LeuvenVerified postcodeLeuven, Belgium· Recruiting
- Mount Sinai HospitalVerified postcodeToronto, Canada· Recruiting
- Centre Médico-Chirurgical et ObstétricalVerified postcodeSchiltigheim, France· Recruiting
- Universitätsklinikum Hamburg-EppendorfVerified postcodeHamburg, Germany· Recruiting
- Sheba Medical CenterVerified postcodeTel Litwinsky, Israel· Recruiting
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoVerified postcodeMilan, Italy· Recruiting
- Ospedale dei Bambini Vittore BuzziVerified postcodeMilan, Italy· Recruiting
- Leiden University Medical CenterVerified postcodeLeiden, Netherlands· Recruiting
- Hospital Universitari Vall d'HebronVerified postcodeBarcelona, Spain· Recruiting
- Birmingham Women's HospitalVerified postcodeBirmingham, United Kingdom· Recruiting
Common questions
What is TRAP sequence?
It's a rare issue in twin pregnancies where one twin doesn't develop normally and gets blood backward from the healthy twin, putting the healthy twin at risk.
Why is this study important?
It helps doctors figure out if treating TRAP sequence early or later in pregnancy gives the healthy twin the best chance to be born healthy.
What does 'randomly assigned' mean?
It means whether you get early or late treatment is decided by chance, like a lottery, to make the study fair and unbiased.
Is the treatment painful?
The procedure is done with local pain relief or light sedation, so you should be comfortable during the treatment.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, and it won't affect your medical care.
How to find out more
Isabel Couck, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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