Cook´s balloon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study)
This research, called the COLIGROW study, is for women who are pregnant, have reached their due date, and whose babies aren't growing at the normal rate. The study wants to find out the best way to gently start labour for these women. Doctors will compare two methods: using a special balloon that's placed inside to help open the cervix, or using a medicine called dinoprostone (often known as Propess) which is also placed in the vagina. The main goal is to see which method is more effective in helping women have a vaginal birth. This is an important step to confirm which treatment is better for mums and babies in this specific situation.
At a glance
What is this study about?
When a baby isn't growing well in the womb, doctors might decide it's safer to help start labour sooner rather than waiting. This study, called COLIGROW, is looking at the safest and most effective way to do this for pregnant women who are at full term, meaning their pregnancy has reached about 37 weeks or more.
The study is comparing two common methods used to prepare the body for childbirth. One method involves using a soft, small balloon that is gently placed inside the cervix (the neck of the womb). This balloon helps the cervix to open up naturally over time. The other method uses a medicine called dinoprostone, which comes as a small insert placed in the vagina. This medicine helps to soften and open the cervix, getting it ready for labour.
The main aim of this research is to see which of these two methods is better at helping women have a vaginal delivery. By finding out which treatment works best, doctors can improve care for women and babies where growth is a concern. This is a "Phase III" study, which means it's a final step to confirm if one treatment is better and safer than the other before it might become a standard treatment option.
Key takeaways
- This study compares two ways to start labour: a balloon or a vaginal medicine.
- It's for pregnant women whose babies are not growing as expected.
- The goal is to find the best way to help mothers have a vaginal birth.
- You would be closely monitored throughout your participation.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for pregnant women who are 18 years old or older. There is no upper age limit, meaning women of any adult age can be considered.
The study is specifically for women who are carrying one baby and have reached full term in their pregnancy. A key factor for joining is that doctors have identified that the baby is not growing as much as expected.
Only women are able to take part because the study is about pregnancy and childbirth. If you are pregnant, over 18, and your doctor has told you your baby's growth is restricted, you might be able to join this study.
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.
- Am I at least 18 years old?
- Am I currently pregnant with one baby and at term (around 37 weeks or more)?
- Has my doctor told me my baby has fetal growth restriction?
- Am I open to receiving either a balloon or a vaginal medicine to induce labour?
- Do I live in the UK and would be able to attend study visits?
What does participation involve?
If you decide to take part in this study, you would first have a full discussion with the study team about what's involved and have all your questions answered. You would then be asked to give your consent to join. Once enrolled, you would be randomly assigned to receive either the 'Cook's balloon' or the dinoprostone medicine to help start your labour.
Throughout your time in the study, doctors and nurses would carefully monitor you and your baby. This would involve regular checks of your health and the baby's well-being, similar to what you would experience during any labour induction. The study team would specifically track how your labour progresses and whether you have a vaginal delivery. After your baby is born, there would be some follow-up to ensure both you and your baby are doing well. The total duration of your participation would cover your labour, delivery, and a short postnatal period, typically until you and your baby are discharged from the hospital.
Potential risks and benefits
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Common questions
What does 'fetal growth restriction' mean?
It means your baby isn't growing as much as expected in the womb, which doctors notice during scans.
What is Propess?
Propess is a common brand name for dinoprostone, a medicine placed in the vagina to help soften and open the cervix to start labour.
What is a Cook's balloon?
It's a small, soft balloon device gently placed in the cervix to help it slowly open and prepare for labour.
Will I get to choose which treatment I receive?
No, in this type of study, you'd be randomly assigned to either the balloon or the medicine, like flipping a coin, to ensure fair comparison.
Is the study just about having a vaginal delivery?
The main focus is which method is better at helping achieve a vaginal delivery, but your safety and your baby's safety are always the top priorities.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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