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

Analgesia, Epidural Clinical Trial

— TREAT  

Official title:

The Randomised Epidural Analgesia in Term Delivering Women Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261689
• Other study ID #: TREAT01
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: November 26, 2013
• Start date: September 2008
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ropivacaine/ Sufentanil according to local hospital protocol
according to local hospital protocol

Other:
• Care-as usual pain treatment
Pain treatment only on request of the women in labour. Treatment is given according to local hospital protocol.

Locations

Country	Name	City	State
Netherlands	Atrium Medical Centre Parkstad	Heerlen	Limburg
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	instrumental delivery	The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections)	at labour	No
Secondary	start labour	start labour: spontaneous or induction	during labour	No
Secondary	Oxytocin use	Oxytocin use registration during labour.	During labour	No
Secondary	Duration ruptured membranes	Registration of duration of ruptured membranes	Labour	No
Secondary	Internal digital vaginal examinations	Counting of the total amount of vaginal examinations untill delivery	Labour	No
Secondary	Maternal fever	Defined as a temperature equal or above 38 degrees celsius.	During labour	No
Secondary	Maternal antibiotic use		During labour	No
Secondary	Duration of second stage of labour		labour	No
Secondary	Obstetric complications	For example hemorrhagia postpartum defined as > 1000 ml or third/ fourt degree perinael rupture, shoulder dystocia.	labour	No
Secondary	Epidural related complications	Epidural related complications, for example: bleeding, infection, postpunction headache.	labour and postpartum	No
Secondary	Duration epidural	The duration in hours of the epidural untill the delivery.	labour	No
Secondary	Maternal hypotension	Registration of the occurence of hypotension during labour.	Labour	No
Secondary	Motor block	Motor block defined by the brommage score (only patients with epidural)	Labour	No
Secondary	Other use of anaesthetics	Registration of the use of other used anaesthetics during labour.	Labour	No
Secondary	Neonatal condition	Apgar, umbilical blood gasses.	Postpartum	No
Secondary	Neonatal antibiotic use		Postpartum	No
Secondary	Neonatal admission		postpartum	No
Secondary	Maternal pain catastrophizing		Antepartum	No
Secondary	Beliefs about epidural	Inventarisation of the beliefs about epidural analgesia	antepartum	No
Secondary	Maternal childbirth experience	Inventarisation of the maternal childbirth experience	6 weeks postpartum	No
Secondary	Quality of life	Inventarisation of the quality of life	antepartum, 6 weeks postpartum	No