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Analgesia, EpiduralTREATNCT01261689

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

A study testing Ropivacaine/ Sufentanil according to local hospital protocol and Care-as usual pain treatment in people with Analgesia, Epidural and Instrumental Delivery, run by Maastricht University Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
What is being tested?
Ropivacaine/ Sufentanil according to local hospital protocol and Care-as usual pain treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
2 sitesNetherlands
Study dates
Sep 2008to Nov 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites
  • Atrium Medical Centre Parkstad

    Heerlen, Limburg, 6419 PC

  • Maastricht University Medical Centre

    Maastricht, Limburg, 6202 AZ

Other trials in Netherlands

About this study

Official title: 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.
Read the 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.

Being tested
Ropivacaine/ Sufentanil according to local hospital protocol, Care-as usual pain treatment
Keywords
Epidural analgesia, Instrumental delivery, Maternal outcome, Neonatal outcome
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine/ Sufentanil according to local hospital protocolDrug

    Also called ropivacaine/sufentanil

    according to local hospital protocol

  • Care-as usual pain treatmentOther

    Also called systemic opioids intramuscular and/or epidural analgesia

    Pain treatment only on request of the women in labour. Treatment is given according to local hospital protocol.

Study groups in NCT01261689
Study groupRoleWhat they receive
Epidural analgesiaActive comparatorWomen will be allocated to the EA group. In the EA group, women are given an EA as soon as they are in labour.
Receives: Drug: Ropivacaine/ Sufentanil according to local hospital protocol
Care as-usual pain treatmentOtherWomen 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.
Receives: Other: Care-as usual pain treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. instrumental delivery

    The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections)

    Measured: at labour

Secondary outcomes (20)
  1. start labour

    start labour: spontaneous or induction

    Measured: during labour

  2. Oxytocin use

    Oxytocin use registration during labour.

    Measured: During labour

  3. Duration ruptured membranes

    Registration of duration of ruptured membranes

    Measured: Labour

  4. Internal digital vaginal examinations

    Counting of the total amount of vaginal examinations untill delivery

    Measured: Labour

  5. Maternal fever

    Defined as a temperature equal or above 38 degrees celsius.

    Measured: During labour

  6. Maternal antibiotic use

    Measured: During labour

  7. Duration of second stage of labour

    Measured: labour

  8. Obstetric complications

    For example hemorrhagia postpartum defined as > 1000 ml or third/ fourt degree perinael rupture, shoulder dystocia.

    Measured: labour

  9. Epidural related complications

    Epidural related complications, for example: bleeding, infection, postpunction headache.

    Measured: labour and postpartum

  10. Duration epidural

    The duration in hours of the epidural untill the delivery.

    Measured: labour

  11. Maternal hypotension

    Registration of the occurence of hypotension during labour.

    Measured: Labour

  12. Motor block

    Motor block defined by the brommage score (only patients with epidural)

    Measured: Labour

  13. Other use of anaesthetics

    Registration of the use of other used anaesthetics during labour.

    Measured: Labour

  14. Neonatal condition

    Apgar, umbilical blood gasses.

    Measured: Postpartum

  15. Neonatal antibiotic use

    Measured: Postpartum

  16. Neonatal admission

    Measured: postpartum

  17. Maternal pain catastrophizing

    Measured: Antepartum

  18. Beliefs about epidural

    Inventarisation of the beliefs about epidural analgesia

    Measured: antepartum

  19. Maternal childbirth experience

    Inventarisation of the maternal childbirth experience

    Measured: 6 weeks postpartum

  20. Quality of life

    Inventarisation of the quality of life

    Measured: antepartum, 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2010 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01261689
Sponsor's protocol ID
TREAT01
Acronym
TREAT
Status last verified
Nov 2013
First submitted
10 Nov 2010
Last updated
27 Nov 2013
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 21392241

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine/ Sufentanil according to local hospital protocol and Care-as usual pain treatment in people with Analgesia, Epidural and Instrumental Delivery, run by Maastricht University Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

instrumental delivery (time frame: at labour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01261689, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.

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