Epidural Analgesia in term nulliparous women with a child in occiput presentation who are allowed a Trial of vaginal labour (EAT)

Labour pain can be regarded as one of the most serious kinds of pain.[1] In
many countries labour pain is effectively treated on request of the labouring
woman.[2] In The Netherlands, labour pain has been traditionally approached
conservatively. However, this policy is rapidly changing into effective
treatments on request.[3]

Epidural analgesia (EA) has been proven to be one of the most effective methods
of pain relief during labour.[4,5] In addition, EA leads to increased patient
satisfaction. Compared with other (or no) methods of pain relief, however, EA
is associated with more use of oxytocin, a longer second stage of labour, and
more instrumental vaginal deliveries. Other possible adverse effects in
labouring women during EA are hypotension, motor block, urine retention, and
fever. These complications and adverse effects are possible reasons, why EA is
still not widely advised and accepted in The Netherlands.[6]

However, the question whether these adverse effects are caused by the EA, or
that the observations are biased is still unanswered. The studies that have
been performed to address these items are not applicable to the general
population of women delivering a child, as they were all performed in women in
strong need of pain relief.[4,5] Generally, the need for pain relief is
increased when progression of labour is difficult, for example in case of a
relatively great child or ineffective contractions, especially in nulliparous
women. It is well known that in this group of labouring women, also without EA,
obstetrical problems are increased. On the other hand, a multivariable analysis
of factors that are associated with an arrest of labour indicates, that women
with EA have a decreased risk of arrest of labour (LVR 2004). At present,
randomized controlled trials that study the obstetrical consequences of EA in
nulliparous women without strong need of pain relief are lacking.
Besides that, only a few studies have extensively looked at the preference of
women for EA. It seems that parity status, the fear of the side effects of EA,
pain catastrophizing, the desire to have a pain-free childbirth, positive
experiences with EA of family and friends influence the odds of choosing EA.[12]

So, based on the international literature, the ongoing increase in The
Netherlands of EA*s on maternal request during delivery may result in more
obstetrical problems and increased health costs.[4,5,7] Of course a change in
pain treatment surrounding birth will have an impact for the women in labour,
as well as for the society. On the one hand the costs of care are likely to
increase due to EA, as EA is more expensive and might lead to an augmentation
of medical complications, on the other hand in the EA-group women will have
less pain while in labour as compared to the non-EA group. The question
remains, whether this can be counteracted by a proactive policy of offering EA
before explicit maternal request for pain relief in the absence of obstetrical
problems. It is assumed, that a proactive policy might result in effective pain
reduction and increased patient satisfaction without increased obstetrical
problems and without increased health costs.

Epidural analgesia (EA) is an effective method to reduce labour pain. At
present, it is unknown whether use of EA increases labour complications, and
what the costs of EA are. In this proposal, we assess the impact of a proactive
policy of offering EA at the start of labour as compared to a restrictive
policy.

Multicentre randomised open label trial.

Women will be allocated to the EA group or the non-EA group. In the EA group,
women are given an EA as soon as they are in labour. In the non-EA
(restrictive) group, women receive pain relief only on their explicit request.
Non-participants of the randomized trial will be asked to participate in an
observational study of their labour experience.

Not applicable