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CompletedObservational

Standardisation, acceptability and outcomes of elective (planned) caesarean births where the baby's head is delivered first, and the baby is not fully delivered until after they have taken their first cry or 2 minutes have passed (whichever is sooner)

Doctors are studying a new way to perform planned (elective) C-sections. Instead of delivering the baby very quickly, the doctor will deliver the baby's head and then wait a short time for the baby to take their first cry or for two minutes to pass before delivering the rest of the baby. This 'Time-to-Transition Caesarean Birth' aims to help babies clear fluid from their lungs, making it easier for them to breathe after birth. Babies born by planned C-section can sometimes have 'wet lungs,' which is when fluid stays in their lungs, making them breathe fast. This study hopes to reduce this problem. They will observe mothers and babies closely to see if this new method is helpful and safe. This is a first step to see if a larger study should be done.

At a glance

Status
Completed
Sponsor
North Bristol NHS Trust
Enrolment target
34
Start
08 Mar 2024
Estimated completion
20 Jun 2024

What is this study about?

When a baby is in the womb, their lungs are filled with fluid to help them grow. As they get ready for birth, most of this fluid naturally clears so they can breathe air. Sometimes, especially with planned C-sections, babies might be born very quickly, which doesn't give them enough time to clear this fluid properly. This can lead to 'wet lungs' (a condition called Transient Tachypnea of the Newborn or TTN), making it harder for them to breathe. These babies might need extra help, medication, or even a stay in special care.

This study is looking at a new way to do a planned C-section called a 'Time-to-Transition Caesarean Birth.' Normally, during a C-section, the baby is delivered quite quickly. In this new method, the doctor will gently deliver the baby's head first. The rest of the baby will then stay inside the womb for a short time – either until the baby cries, or for up to two minutes, whichever happens first. This pause is designed to be similar to the natural transition time babies have during a vaginal birth, allowing more time for their lungs to clear any fluid.

The main goal of this small, first-of-its-kind study is to see if this new C-section method is possible and safe to do. It will also help doctors decide if a bigger study is needed to find out for sure whether it helps reduce the problem of 'wet lungs' in babies born by planned C-section. Everything else about the C-section and your recovery will stay the same.

Key takeaways

  • This study is testing a new way of doing planned C-sections.
  • The new method involves a short pause after the baby's head is delivered.
  • The aim is to help babies clear lung fluid, making breathing easier after birth.
  • This is a first step to see if a larger study would be beneficial.
  • You and your baby will be closely monitored throughout the procedure.
  • Taking part could help shape care for future families.

Who may be eligible?

This study is looking for around 34 pregnant women who are having a planned C-section at Southmead Maternity Unit in Bristol. To be part of the study, you need to be at least 16 years old and be pregnant with one baby who is positioned head-down.

You can't join the study if you're having twins or more, if your waters have already broken, or if your baby isn't head-down (for example, if they are breech). You also can't take part if you need to have your C-section under a general anaesthetic (where you are fully asleep), or if you have certain other medical conditions your doctor will discuss with you. If you agree to take part, you'll also need to be comfortable with your baby's birth being filmed using hospital cameras, as this helps the study team learn from each birth. Your birth partner can also take part if they are at least 16 years old and present at the birth.

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.

  1. Are you having a planned C-section at Southmead Maternity Unit?
  2. Is your pregnancy with one baby?
  3. Is your baby positioned head-down?
  4. Are you comfortable with your baby's birth being filmed?
  5. Are you aged 16 or over?
Answer every question to see your result.

What does participation involve?

If you decide to take part, your planned C-section will be performed using this new 'Time-to-Transition' method. This means your baby's head will be delivered first, and then there will be a short wait of up to two minutes (or until your baby cries) before the rest of your baby is born. During this time, you and your baby will be carefully watched by the medical team.

After the birth, the study team will collect information about you and your baby's health from your hospital notes for the first four weeks. They will also video the birth using hospital cameras to help them understand the new technique better. You and your birth partner will be asked about your experiences of the birth, and healthcare staff will also share their thoughts. The study is running from March 2024 to September 2024.

Potential risks and benefits

We don't yet know if this new C-section method is better than the standard one. Our hope is that the 'Time-to-Transition' birth might reduce the chance of your baby having 'wet lungs' and needing extra breathing help or a stay in special care. However, we cannot promise any direct benefits to you or your baby at this stage, as this study is designed to help us find out. But by taking part, you could be helping future families. We don't expect this new method to be any riskier for you or your baby than a standard C-section. During all C-sections, including this study, you and your baby are closely monitored. If there are any concerns about either of you, the baby will be delivered immediately. You are free to withdraw from the study at any time without affecting your care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • North Bristol NHS Trust
    City only
    Bristol, England

Common questions

What are 'wet lungs' in babies?

It's when some fluid stays in a baby's lungs after birth, making it harder for them to breathe fast and easily. It's usually temporary and clears up.

How is this different from a standard C-section?

During a standard C-section, the baby is usually delivered quite quickly. In this study, after the baby's head is delivered, there's a short pause (up to 2 minutes or until they cry) before the rest of the baby is born.

Will my C-section still be safe?

Yes, your medical team will monitor you and your baby very closely throughout the C-section, just like a standard one. If there are any concerns, the baby will be delivered immediately.

Why is the birth being filmed?

The video helps the study team learn from each birth, fine-tune the new technique, and understand how the babies are transitioning.

Who is paying for this study?

The study is being funded by donations made to the Southmead Hospital Charity in Bristol.

How to find out more

Joanna Crofts

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

Discussion

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