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

The Randomised Epidural Analgesia in Term Delivering Women Trial

* 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.

Study Overview

• Status: Completed
• Conditions: Analgesia, Epidural; Neonatal Outcome; Instrumental Delivery; Maternal Outcome
• Intervention / Treatment: Drug: Ropivacaine/ Sufentanil according to local hospital protocol; Other: Care-as usual pain treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419 PC
      • Atrium Medical Centre Parkstad
    • Maastricht, Limburg, Netherlands, 6202 AZ
      • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural analgesia; 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; according to local hospital protocol; Other Names: ropivacaine/sufentanil
Other: Care as-usual pain treatment; 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; Pain treatment only on request of the women in labour. Treatment is given according to local hospital protocol.; Other Names: systemic opioids intramuscular and/or epidural analgesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Study Chair: Jan Nijhuis, Prof. MD, PhD, Maastricht University Medical Center; Principal Investigator: Martine Wassen, MD, Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 10, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Epidural analgesia; Neonatal outcome; Instrumental delivery; Maternal outcome
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Ropivacaine; Sufentanil; Dsuvia
• Other Study ID Numbers: TREAT01