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Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial)

Reference: The Lancet, Early Online Publication, 25 October 2011

Source: Lancet

Date published: 25/10/2011 17:20

Summary
by: Hina Radia

According to a study published early online in The Lancet, in women with an unfavourable cervix at term, induction of labour with a Foley catheter is similar to induction of labour with prostaglandin E2 gel, with fewer maternal and neonatal side-effects.

 

Researchers performed an open-label trial to compare the effectiveness and safety of induction of labour with a Foley catheter to that with induction using vaginal prostaglandin E2 gel. The trial, conducted in 12 hospitals in the Netherlands, involved women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix, an indication for induction of labour, and no prior caesarean section. Patients were randomised to induction of labour with a 30 mL Foley catheter (n=412) or vaginal prostaglandin E2 gel (n=412). The primary outcome was caesarean section rate, and secondary outcomes were maternal and neonatal morbidity and time from intervention to birth.

 

The following results were reported:

• Caesarean section rates were much the same between the two groups (23% vs 20%, risk ratio [RR] 1.13, 95% CI 0.87—1.47).

• Two serious maternal adverse events, both in the prostaglandin group were recorded: one uterine perforation and one uterine rupture.

 

The researchers conclude that the Foley catheter should be considered for induction of labour in women with an unfavourable cervix at term. Prostaglandin E1 is becoming increasingly popular for cervical ripening worldwide, and thus, future research should focus on the comparison of Foley catheters with other prostaglandin preparations, such as misoprostol, and with use of Foley catheters in women with a previous caesarean birth.

An editorial has also discussed this study

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