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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Kirandeep
Sunner
+44 (0)121 4159100
K.K.Sunner@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Obstetrics: Mid Trimester Miscarriage and Preterm Birth
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
A cervical cerclage is the placement of a stitch to keep the neck of the womb (cervix) closed. A stitch can be placed in a planned way because of a perceived risk of premature birth based on a woman’s pregnancy history or because the neck of the womb is shorter than normal on an ultrasound scan but still closed. Sometimes the neck of the womb can start to open early and the bag of water around the baby (amniotic sac) can come through the neck of womb. If this happens between 16 and 28 weeks of pregnancy an emergency rescue stitch can be performed to try and delay delivery. Prolonging the pregnancy so that the baby can be born when they are bigger and stronger may give them a better chance of surviving and suffering from fewer complications of prematurity. Doctors do not know if a rescue cerclage works. There is some evidence it may prolong pregnancy but it is possible that it may also speed up delivery by causing infection or cause damage to the neck of the womb of the mother. It is therefore very important to perform a study to decide if rescue cerclages delay delivery and if it does whether this benefits the baby (and mother). The best way to work out if rescue cerclage works, and is safe, is to ask women to be randomly allocated to the treatment. This is what we need to do to ensure we know what is best for future women and babies to prevent harm. This study will ask women who have an open neck of the womb with the bag of waters around the baby coming through, to have either a rescue stitch or no rescue stitch the treatment arm will be decided by a process that randomly allocate to one group or the other. All women in the study irrespective of the allocated group will be able to have other treatments that may help prolong pregnancy such as antibiotics, progesterone and medicines that stop the womb contracting (although none of these have been proven to delay labour or improve health of babies). The study team will collect what happens to the mum and baby from their medical notes. All babies will also be reviewed at 2 years of age to assess how they are developing by a postal questionnaire completed by the parents.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2021 Protocol article in https://doi.org/10.1186/s13063-021-05464-6 (added 26/09/2023)
You can take part if:
You may not be able to take part if:
1. Contraindication to rescue cerclage as judged by the clinician 2. Cervical cerclage (vaginal or abdominal) inserted earlier in this pregnancy
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Kirandeep
Sunner
+44 (0)121 4159100
K.K.Sunner@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Birmingham Women's and Children's NHS foundation trust. and funded by National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 40203
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
