INDEX:Costs and effects of induction of labour versus expectant management in women with impending post-term pregnancies: the 41 week-42 week dilemma

Post-term pregnancy is associated with increased perinatal morbidity and
mortality and is considered as a high-risk stage which requires specialist
surveillance and induction of labour at some stage. However, there is
uncertainty in The Netherlands on the policy concerning the timing of induction
for post-term pregnancy, leading to practice variation and strong debates
between caregivers regarding pros and cons of labour induction for impending
post-term pregnancy. To solve this dilemma in the Netherlands we propose a
randomised trial to evaluate the effectiveness, costs and cost-effectiveness
analysis of policy of labour induction at 41 weeks versus expectant management
until 42 weeks in low risk women. We will study adverse perinatal outcome,
adverse maternal outcomes, client satisfaction, preferences and costs.

First Objective
In this study we compare a policy of labour induction at 41 weeks with a policy
of expectant management until 42 weeks, with an outpatient check for CTG
monitoring and ultrasound measurement in the 42nd week, with respect to the
adverse perinatal outcome rate.

Secondary Objective(s):
Based on the data obtained, we will perform a cost-effectiveness analysis
incorporating instrumental delivery rates, client satisfaction and costs.

We will analyse costs of both strategies, as well as clients* preferences,
pain, anxiety and maternal satisfaction.

We will answer the following specific questions:
What is in a policy of induction of labour at 41 weeks as compared to a policy
of expectant management until 42 weeks
* Maternal satisfaction
* The instrumental delivery rate including Caesarean sections
* Need for pain relieve
* Perineal injury
* Post partum hemorrhage
* Use of health care resources
* Clients* preferences

The study is a multi-centre randomised clinical trial with a cost-effectiveness
analysis and a preference study alongside it.

Induction of labour according to local protocol.

Participants fill out questionnaires at five occasions; at four occasions this
will take them about 15 minutes, the fifth questionnaire will take less than 5
minutes to be answered. Although formally induction of labour is only indicated
at 42 weeks gestational age, at many hospitals it is actual practice to induce
at 41 weeks GA. This study therefore compares two common treatment strategies
as a result of which it will not impose extra risk on the participants.