Benefits and risks

Information for the public

When NICE looked at the evidence, it decided that inserting a double balloon catheter to induce labour in pregnant women who have not had a previous caesarean section is safe enough and works well enough for use in the NHS. The 9 studies that NICE looked at involved a total of 2262 patients.

Generally, they showed the following benefits:

softening of the cervix in 96% of women, which is similar to when a single ballon is used
no increase in, or fewer, caesarean deliveries
spontaneous vaginal delivery within 24 hours in 69% of women
a positive birth experience in almost 90% of women.

The studies showed that the risks of a double balloon catheter included:

excessive contractions of the uterus in 5% of women, but this was much less than with prostaglandin gel (17%)
worrying heart rate in 2% of babies, but this was much less than with prostaglandin gel (15%)
baby presenting the wrong way round in 2 women, 1 of whom needed a caesarean section
cord prolapse, resulting in a caesarean section in 1 woman
haemorrhage after delivery in 5% of women, which was no more common than with other methods
injury to the birth canal in 1 woman compared with 5 women given prostaglandin gel
fever during labour in 8 women
infection in 4 babies
more pain with the double balloon than with a single balloon catheter but less than with prostaglandin gel.

NICE was also told about another possible risk: a delay between the start of induction and delivery of the baby.

If you want to know more about the studies, see the guidance. Ask your health professional to explain anything you don't understand.