The randomised epidural analgesia in term delivering women trial.

Objective:

Epidural analgesia (EA) is an effective method to reduce labour pain. In this proposal, we determine the beliefs and characteristics of women about epidural analgesia and we asses the impact of a proactive policy of offering EA at the start of labour as compared to a restrictive policy on maternal pain reduction, obstetrical complications, neonatal outcomes and maternal experience of the delivery. Besides we want to gain insight in the influence of pain catastrophizing on the experienced pain and fear for labour. Also we want to investigate if chronic pain after labor and delivery is a problem.



Study design:

Bicentre randomised open label trial. It concerns a pilot study.



Study population:

Term nulliparous and multiparous women with a child in cephalic presentation, and without contraindications for vaginal labour or EA.



Interventions:

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.



Outcome measures:

The primary outcome is the number of vaccuumextractions. Secondary outcomes are the use of oxytocin,maternal pain during labour, the number of instrumental vaginal deliveries, the number of caesarean sections, the duration of the second stage of labour, maternal hypotension, motor block, urine retention, fever, obstetric complications, antibiotics and anaesthetics used, neonatal condition, maternal experience of the delivery and quality of life.

The objective of the study is to assess the impact of a proactive policy of offering EA at the start of labour before maternal request in women with a child in occiput presentation allowed to try a vaginal delivery, on maternal pain reduction, obstetrical complications, neonatal outcomes, and maternal experience of the delivery. Furthermore, we want to gain insight on the basis of which characteristics (attributes) women in labour chose for (prefer) epidural analgesia.



Our hypotheses is that the number of instrumental deliveries in both groups is the same (non inferiority trial) (primary outcome).

1. Baseline at 36 weeks of gestation;

2. During labor;

3. 8 hours, 6 weeks and 6 months after delivery.

Women will be allocated at random into two different groups:

1. EA group: These women are given an EA as soon as possible as they are in labour, judged by the attending gynaecologist and based on an effaced cervix with at least 2 cm dilation at vaginal examination;

2. Non-EA (restrictive) group: These women receive pain relief only on their explicit request. According to local preferences, several methods of pain relief are allowed, including EA in case other methods have failed.