The Randomised Epidural Analgesia in Term Delivering Women Trial (TREAT)

Study Overview
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Brief Summary
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* 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
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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.

Official Title
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The Randomised Epidural Analgesia in Term Delivering Women Trial

Conditions
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Analgesia, Epidural, Instrumental Delivery, Maternal Outcome, Neonatal Outcome

Intervention / Treatment
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* Drug: Ropivacaine/ Sufentanil according to local hospital protocol
* Other: Care-as usual pain treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural analgesia<br>Women will be allocated to the EA group. In the EA group, women are given an EA as soon as they are in labour. | Drug: Ropivacaine/ Sufentanil according to local hospital protocol<br>* according to local hospital protocol<br>* Other names: ropivacaine/sufentanil;|
| Other: Care as-usual pain treatment<br>Women will be allocated to the care-as-usual group. In this care-as-usual(restrictive) group, women receive pain relief only on their explicit request. If necessary epidural analgesia. | Other: Care-as usual pain treatment<br>* Pain treatment only on request of the women in labour. Treatment is given according to local hospital protocol.<br>* Other names: systemic opioids intramuscular and/or epidural analgesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| instrumental delivery | The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections) | at labour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| start labour | start labour: spontaneous or induction | during labour | 
| Oxytocin use | Oxytocin use registration during labour. | During labour | 
| Duration ruptured membranes | Registration of duration of ruptured membranes | Labour | 
| Internal digital vaginal examinations | Counting of the total amount of vaginal examinations untill delivery | Labour | 
| Maternal fever | Defined as a temperature equal or above 38 degrees celsius. | During labour | 
| Maternal antibiotic use |  | During labour | 
| Duration of second stage of labour |  | labour | 
| Obstetric complications | For example hemorrhagia postpartum defined as > 1000 ml or third/ fourt degree perinael rupture, shoulder dystocia. | labour | 
| Epidural related complications | Epidural related complications, for example: bleeding, infection, postpunction headache. | labour and postpartum | 
| Duration epidural | The duration in hours of the epidural untill the delivery. | labour | 
| Maternal hypotension | Registration of the occurence of hypotension during labour. | Labour | 
| Motor block | Motor block defined by the brommage score (only patients with epidural) | Labour | 
| Other use of anaesthetics | Registration of the use of other used anaesthetics during labour. | Labour | 
| Neonatal condition | Apgar, umbilical blood gasses. | Postpartum | 
| Neonatal antibiotic use |  | Postpartum | 
| Neonatal admission |  | postpartum | 
| Maternal pain catastrophizing |  | Antepartum | 
| Beliefs about epidural | Inventarisation of the beliefs about epidural analgesia | antepartum | 
| Maternal childbirth experience | Inventarisation of the maternal childbirth experience | 6 weeks postpartum | 
| Quality of life | Inventarisation of the quality of life | antepartum, 6 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural analgesia, Instrumental delivery, Maternal outcome, Neonatal outcome