Prematurity in singletons
Patient information
Randomized study of pessary vs expectant management in women with singleton pregnancies and a short cervix
We would like to invite you to take part in a research study. Before you decide you need to understand why the research is being done and what it would involve for you. Please take time to read the following information carefully and discuss it with your family or friends or your doctor if you wish.
What is the purpose of the study?
The chance that a woman will go into labour and deliver before 34 weeks is about 1% but in your case because your cervix is short the chance of premature birth before 34 weeks is increased (44% for cervix of 1-10 mm, 23% for cervix of 11-15 mm and 4% for cervix of 16-25 mm).
The majority of babies born prematurely survive and develop normally. However, babies born before 34 weeks have a higher chance of dying soon after birth or becoming disabled than babies born at term.
There is some evidence that in pregnancies with a previous premature birth or a short cervix (1-15 mm) the chances of premature birth may be reduced by them taking progesterone. If you are in these groups we will offer you progesterone as part of our standard care. However, even with the use of progesterone your chances of premature birth are still increased.
There is some evidence that in women with a short cervix the use of a vaginal pessary reduces the chances of premature birth but the evidence is weak and therefore this issue needs further investigation.
We are inviting you to take part in a trial to determine if a vaginal pessary reduces the chances of premature birth. This trial will involve 1,600 women and will take about four years to complete.
Why have I been invited?
This is just because we have found that your cervix is short. Sometimes we don't know which way of treating patients is best. To find out, we need to compare different treatments. We put people into groups and give each group a different treatment. The results are compared to see if one is better. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly).
Do I have to take part?
It is up to you to decide whether or not to take part. If you decide not to take part in the study your standard of care will not be affected.
What will happen to me if I take part?
You will be allocated to one or other of two groups either the standard management group or the pessary group. The group to which you are allocated is selected by a computer and the chance of being allocated into each group is equal. There is a 50-to-50 chance of being in the group of standard management or pessary. Irrespective of which group you are allocated to, if your cervix measures 15 mm or less you will be given prophylactic progesterone (you will need to insert a capsule into your vagina every night up to the 34 th week of your pregnancy).
At the time of your routine scan at 20 weeks we will discuss with you if you want to take part in the study. If you decide to take part you can let us know during your 22 weeks visit at which time we will ask you to sign a consent form. If you are allocated into the pessary group the pessary will be inserted at this 22 weeks visit.
The pessary is made of silicone which is soft and flexible. It is folded and introduced around the cervix by a simple vaginal examination without causing any pain. The pessary will remain within the vagina for several weeks, it does not produce any discomfort, it does not cause an infection, it does not fall off, it does not need to be changed and you or your partner will not feel anything different during sexual intercourse.
The pessary will be removed by a simple vaginal examination at 37 weeks. If any problems arise during the course of the pregnancy your obstetrician may advise an earlier delivery. If you go into labour before the time of planned delivery or your waters break (premature rupture of membranes) or you experience vaginal bleeding you need to be examined by a doctor or a midwife and if necessary the pessary may need to be removed.
Irrespective to which group you are allocated you should be seen by a doctor every four weeks and have ultrasound scans to examine the babies and measure the length of your cervix.
What is the medical device that is being tested?
This is a pessary consisting of flexible comfortable silicone which is not harmful to you or your baby.
What are the side effects of the pessary?
Previous studies using the pessary have shown no adverse effects on the baby. A few women may experience increased vaginal discharge but the pessary does not cause a vaginal infection. During your visits to the hospital we will ask you if you have developed any vaginal discharge. If you have such a discharge you should be examined by your doctor to find out if you have an infection and treat you with the necessary antibiotics.
What are the possible disadvantages or benefits of taking part?
We do not know at this stage of the trial whether the pessary is beneficial or not. The results of this study may help us to manage women with a short cervix better in the future. If during the course of the research new information becomes available about this treatment, we will discuss it with you. In the light of new information, you or your research doctors decide that you should withdraw from the trial this will be arranged.
Will my taking part in this study be kept confidential?
All information that is collected about you during the course of the research will be kept strictly confidential and any information that leaves the hospital will have your name or address removed so that you cannot be recognized from it. Your family doctor will be informed of your participation in the trial, with your consent. The details of the delivery of your baby will be available to us from your local hospital. In the event of you delivering away from your hospital, the trial co-ordinator may contact you.
What will happen to the results of the research study?
Following the analysis of the information we get we will make conclusions and publish the results in scientific journals. Your name or personal details will not be identified on any of these.
Who is organising and funding the study?
The study is being conducted by Professor Kypros Nicolaides and his team at King's College Hospital, London. This is funded by the Fetal Medicine Foundation, which is a UK registered charity.
Research Ethics Committee
All research should be looked at by an independent group of people, called a Research Ethics Committee to protect patient safety, rights, wellbeing and dignity. This study has been reviewed and given favourable opinion by King's College Hospital Research Ethics Committee and the equivalent committees in all participating hospitals.
Contact details of researchers
If you require any further information or you have any concerns about the study please send an email to kypros@fetalmedicine.com or call Patricia Colombo at 0044 2070343070.
Vaginal scan: short cervix
Vaginal silicone pessary
