Clinical trial NCT01261689: The Randomised Epidural Analgesia in Term Delivering Women Trial (TREAT)
Official title: The Randomised Epidural Analgesia in Term Delivering Women Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia, Epidural
Instrumental Delivery
Maternal Outcome
Neonatal Outcome
Keywords: Epidural analgesia
Instrumental delivery
Maternal outcome
Neonatal outcome
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 488
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: \* The objective of the study: to assess the impact of a proactive policy of offering EA at the start of labour as compared to a restrictive policy or care as usual.

\* Study design: It concerns a multicentre randomised open label trial.

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

\* Intervention: Women will be allocated to the EA group or the care-as-usual group. In the EA group, women are given an EA as soon as they are in labour. In the care-as-usual (restrictive) group, women receive pain relief only on their explicit request.

Detailed description: Labour pain can be regarded as one of the most serious kinds of pain.In many countries labour pain is effectively treated on request of the labouring woman. In The Netherlands, labour pain has been traditionally approached conservatively. However, this policy is rapidly changing into effective treatments on request.Epidural analgesia (EA) has been proven to be one of the most effective methods of pain relief during labour.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.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.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. 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. 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. 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.

Eligibility criteria: Inclusion Criteria:

* be 18 years or older
* bear a singleton child in cephalic presentation
* be under supervision (second line) for their pregnancy in one of the participating centres.
* have no contraindications for vaginal labour
* have no contraindications for EA: Use of coumarines LMWH in therapeutic dose LMWH in prophylactic dose, less than 10 hours ago Thrombocytes \< 80 x 109/ L Use of thrombocytes aggregation inhibitors or anamnestic increased bleeding tendency Blood clotting disorders Allergy for used anesthetics Spine disorders or back infection

Exclusion Criteria:

* be younger than 18 years
* bear twin pregnancy
* have contraindications for vaginal labour
* have contraindications for EA
* referral by midwife during labour (first line)

Primary outcomes:
measure: instrumental delivery
timeFrame: at labour
Secondary outcomes:
measure: start labour
timeFrame: during labour
measure: Oxytocin use
timeFrame: During labour
measure: Duration ruptured membranes
timeFrame: Labour
measure: Internal digital vaginal examinations
timeFrame: Labour
measure: Maternal fever
timeFrame: During labour
measure: Maternal antibiotic use
timeFrame: During labour
measure: Duration of second stage of labour
timeFrame: labour
measure: Obstetric complications
timeFrame: labour
measure: Epidural related complications
timeFrame: labour and postpartum
measure: Duration epidural
timeFrame: labour
measure: Maternal hypotension
timeFrame: Labour
measure: Motor block
timeFrame: Labour
measure: Other use of anaesthetics
timeFrame: Labour
measure: Neonatal condition
timeFrame: Postpartum
measure: Neonatal antibiotic use
timeFrame: Postpartum
measure: Neonatal admission
timeFrame: postpartum
measure: Maternal pain catastrophizing
timeFrame: Antepartum
measure: Beliefs about epidural
timeFrame: antepartum
measure: Maternal childbirth experience
timeFrame: 6 weeks postpartum
measure: Quality of life
timeFrame: antepartum, 6 weeks postpartum
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Medical Centre Parkstad
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Jan Nijhuis, Prof. MD, PhD
role: STUDY_CHAIR
affiliation: Maastricht University Medical Center
name: Martine Wassen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wassen MM, Zuijlen J, Roumen FJ, Smits LJ, Marcus MA, Nijhuis JG. Early versus late epidural analgesia and risk of instrumental delivery in nulliparous women: a systematic review. BJOG. 2011 May;118(6):655-61. doi: 10.1111/j.1471-0528.2011.02906.x. Epub 2011 Mar 10.