Setting the scene ...

Preterm birth or birth before 37 weeks' gestation remains an important public health problem.  Despite recent medical advances, the number of preterm births each year in the UK continues to rise.  In our own experience at St Thomas' Hospital, the prematurity rate is about 11%.  The effects of preterm birth is not only limited to the infant's early life.  These babies are at high risk of developmental problems, cerebral palsy, birth defects, feeding problems, visual impairment, and hearing loss, among other things. 

The UK alone spends over £4 billion annually on neonatal intensive care for premature babies.  Beyond initial inpatient care, it is impossible to grasp the actual costs of preterm birth: a lot of money is spent on early intervention and special education.  Preterm birth not only results in an anormous financial burden on the affected family, but also affects them emotionally, psychologically and physically.

The weak cervix and cerclage ...

One of the causes of preterm birth is a weak cervix.  If the cervix is weak, it opens as the pregnancy progresses and the fetus is no longer held within the uterus, resulting in a miscarriage or an early delivery.  One of the interventions for a weak cervix is the insertion of a 'stitch', which is known as a cervical cerclage.  This can be done by one of two routes: the abdomen or the vagina.  Most of the time, this is done via the vaginal route as it is less invasive and results in fewer complications.  However, some women still miscarry or have early deliveries regardless of having a vaginal stitch inserted.  We do not understand why this method of prevention works for some women and not for others.  In women who have had a failed vaginal stitch, a reasonable option is to insert a stitch via the abdominal route or placing the vaginal stitch higher than before by dissecting the bladder.  There is a reasonable amount of evidence based on case series to suggest that these are safe, far more effective, and acceptable options, but are more complex to insert and require more intervention. 

What is MAVRIC?

MAVRIC is a pilot study which aims to recruit 129 women from maternity units around the country.  You may be eligible if you have had at least one previous failed vaginal stitch resulting in a miscarriage after 16 weeks or an early delivery before 28 weeks' gestation.  The failed stitch must have been inserted as an elective procedure or following detection of a short cervix on ultrasound.  If you have had a failed emergency cerclage i.e. one put in if the cervical os was open and membranes visible, you are not eligible.  You may be identified in the pre-conception period or during early pregnancy.  If you are eligible and ish to participate, you will be randomised to receive a stitch.  You may have a transabdominal stitch, a high vaginal stitch or a standard vaginal stitch.  Both the transabdominal stitch and the high vaginal stitch may be inserted before you become pregnant.   

The MAVRIC investigators believe that either a transabdominal or a high vaginal stitch will be better than a standard vaginal stitch in women with this history.  We want to compare the rate of delivery <32 weeks, neonatal death, operative complications and timing of stitch insertion in these 3 groups of women.  This study is large enough to determine whether abdominal cerclages will reduce preterm birth before 32 weeks and save babies' lives.  We also want to do a feasibility study so we can define the risk of cerclage insertion.

How will this project help? 

This research project will improve doctors' understanding of when and how to insert stitches in a high-risk woman.  This will result in an improvement in the overall quality of care provided to a woman at risk of preterm birth by preventing them from having miscarriages or early deliveries and providing them with healthy babies. Ultimately, we hope we will be able to alleviate the physical, emotional and psychological impact on families who have already suffered by preventing similar outcomes from occurring in their future pregnancies. 

Patient information documents ...