Induction of labour in hospital with a Foley catheter or oral misoprostol versus induction of labour at home with a Foley catheter or oral misoprostol

Induction of labour is an obstetric intervention that artificially initiates
labour. It is applied around 37000 times (22, 6% of all deliveries) each year
in the Netherlands, which makes it the most frequently applied obstetric
procedure. Approximately 50% of the women whose labour is induced have an
unfavourable cervix at the start of induction. In these women, cervical
ripening is required. Cervical ripening can be achieved with mechanical
methods, such as a Foley catheter, or pharmacologically with prostaglandins.
Regardless which method is used, cervical ripening takes time, and women stay
admitted at the labour ward. This challenges the cost-effectiveness of this
procedure. Outpatient cervical ripening could be a solution. The use of an
outpatient Foley catheter could potentially save almost 1000 euro per woman,
which could give a substantial reduction in costs. Until now there is not
sufficient evidence to know which method is preferred by women nor which is the
safest and effective to use in outpatient settings, neither the
cost-effectiveness.

The aim of this trial is twofold, we will compare safety, (cost)effectivity and
patient preferences of misoprostol compared to a Foley catheter and of clinical
(inhospital) versus outpatient (at home) cervical priming.

Is priming of the cervix, as part of induction of labour:
* At home cost-effective and safe compared to the hospital?
* with oral misoprostol cost-effective and safe compared to a Foley catheter?

A nationwide multicentre open label 2 by 2 factorial randomized controlled
trial with a cost-effectiveness and patientpreference analysis.

1. Misoprostol at home
2. Foley catheter at home.

Both misoprostol and a Foley catheter are standard care in hospitals in the
Netherlands and outside the Netherlands as methods to ripen the cervix as part
of induction of labour. Misoprostol is not yet registered in the Netherlands
as an agent for induction of labour. However, it is registered by Azanta
Denmark A/S for this indication in several countries in the European Union
(e.g. France, Denmark, Norway and Sweden) under the brand name Angusta®. A
recent Cochrane review recommends a dosage of 20 to 25 mcg orally(2).

The Foley catheter is registered as a medical device to provide drainage of the
urinary bladder, therefore in this study it will be studied outside the
intended use. However, it is advised in national and international guidelines
(3, 4) to use as for induction of labour and studied extensively. The firm
Cook® Medical has developed a similar product, the Cook® Cervical Ripening
Balloon which is registered for cervical ripening.
A recent systematic review and meta-analysis compared the Foley catheter to the
Cook® catheter. It concluded both devices to be equally effective and safe but
stated the Foley catheter to remain the logical choice over the Cook® catheter
since the Foley is significantly cheaper, more widely available and accessible
and has a longer history of use (5).

The PROBAAT-II trial proved both misoprostol and the Foley catheter to be safe
methods for both mother and child(6). It might be beneficial for women to await
the results of priming at home rather than being admitted to the hospital:
increased patient satisfaction but also possibly with a better effect on the
priming itself. Non-inferiority of the treatment effects is expected with
regard to safety for mother and child, but we do expect benefit of costs and
increased patient satisfaction.

An analysis of women*s experience and preferences of participating women in the
PROBAAT-II*trial showed women in the Foley group prefer more often to choose a
different method for future inductions compared to women in the oral
misoprostol group (6% vs 12%, RR 0.70, 95% CI 0.55-0.90). There was no other
significant difference in experience between the two methods(6, 7).


After labour we will ask patients to fill out a questionnaire (ca. 30 minutes)
about their experience of the method and location of priming and their labour.
Our trial beholds no additional checks or examinations neither for mother nor
for the newborn.


The WHO advises an oral dose of 25 mcg every 2 hours. The Dutch guideline is
currently under revision. It advises an oral dose of 25 mcg every 2 hour or 50
every 4 hour. When oral admission is not possible or when time to labour is an
important factor it advises a vaginal admission (25-50 mcg every 4 hours).