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.
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
- Conditions the study is for
- Analgesia, Epidural, Instrumental Delivery, Maternal Outcome
- 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
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 group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Active comparator | Women 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 treatment | Other | 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. Receives: Other: Care-as usual pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
start labour
start labour: spontaneous or induction
Measured: during labour
Oxytocin use
Oxytocin use registration during labour.
Measured: During labour
Duration ruptured membranes
Registration of duration of ruptured membranes
Measured: Labour
Internal digital vaginal examinations
Counting of the total amount of vaginal examinations untill delivery
Measured: Labour
Maternal fever
Defined as a temperature equal or above 38 degrees celsius.
Measured: During labour
Maternal antibiotic use
Measured: During labour
Duration of second stage of labour
Measured: labour
Obstetric complications
For example hemorrhagia postpartum defined as > 1000 ml or third/ fourt degree perinael rupture, shoulder dystocia.
Measured: labour
Epidural related complications
Epidural related complications, for example: bleeding, infection, postpunction headache.
Measured: labour and postpartum
Duration epidural
The duration in hours of the epidural untill the delivery.
Measured: labour
Maternal hypotension
Registration of the occurence of hypotension during labour.
Measured: Labour
Motor block
Motor block defined by the brommage score (only patients with epidural)
Measured: Labour
Other use of anaesthetics
Registration of the use of other used anaesthetics during labour.
Measured: Labour
Neonatal condition
Apgar, umbilical blood gasses.
Measured: Postpartum
Neonatal antibiotic use
Measured: Postpartum
Neonatal admission
Measured: postpartum
Maternal pain catastrophizing
Measured: Antepartum
Beliefs about epidural
Inventarisation of the beliefs about epidural analgesia
Measured: antepartum
Maternal childbirth experience
Inventarisation of the maternal childbirth experience
Measured: 6 weeks postpartum
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.
- First posted16 Dec 2010 (estimated)
- Study startSep 2008
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia, EpiduralStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Nijhuis, Prof. MD, PhD, Study chair, Maastricht University Medical CenterMartine Wassen, MD, Principal investigator, Maastricht University Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomised Epidural Analgesia in Term Delivering Women Trial
- ClinicalTrials.gov ID
- NCT01261689
- Acronym / sponsor ID
- TREAT / TREAT01
- Keywords
- Epidural analgesia, Instrumental delivery, Maternal outcome, Neonatal outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | Active comparator | Drug: Ropivacaine/ Sufentanil according to local hospital protocolWomen will be allocated to the EA group. In the EA group, women are given an EA as soon as they are in labour. |
| Care as-usual pain treatment | Other | Other: Care-as usual pain treatmentWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- be younger than 18 years
- bear twin pregnancy
- have contraindications for vaginal labour
- have contraindications for EA
- referral by midwife during labour (first line)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine/ Sufentanil according to local hospital protocolAlso: ropivacaine/sufentanilaccording to local hospital protocol | Drug | Epidural analgesia |
| Care-as usual pain treatmentAlso: systemic opioids intramuscular and/or epidural analgesiaPain treatment only on request of the women in labour. Treatment is given according to local hospital protocol. | Other | Care as-usual pain treatment |
Primary outcome
instrumental delivery
Time frame: at labour
The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections)
20 secondary outcomes
start labour
Time frame: during labour
Oxytocin use
Time frame: During labour
Duration ruptured membranes
Time frame: Labour
Internal digital vaginal examinations
Time frame: Labour
Maternal fever
Time frame: During labour
Maternal antibiotic use
Time frame: During labour
Duration of second stage of labour
Time frame: labour
Obstetric complications
Time frame: labour
Epidural related complications
Time frame: labour and postpartum
Duration epidural
Time frame: labour
Maternal hypotension
Time frame: Labour
Motor block
Time frame: Labour
Other use of anaesthetics
Time frame: Labour
Neonatal condition
Time frame: Postpartum
Neonatal antibiotic use
Time frame: Postpartum
Neonatal admission
Time frame: postpartum
Maternal pain catastrophizing
Time frame: Antepartum
Beliefs about epidural
Time frame: antepartum
Maternal childbirth experience
Time frame: 6 weeks postpartum
Quality of life
Time frame: antepartum, 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
- Background: PubMed 21392241Wassen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Nijhuis, Prof. MD, PhD study chair
Maastricht University Medical Center
Martine Wassen, MD principal investigator
Maastricht University Medical Center
2 sites in 1 country: see every site and its status.
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.