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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01261689
First received: November 10, 2010
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

* 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.


Condition Intervention
Analgesia, Epidural
Instrumental Delivery
Maternal Outcome
Neonatal Outcome
Drug: Ropivacaine/ Sufentanil according to local hospital protocol
Other: Care-as usual pain treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Randomised Epidural Analgesia in Term Delivering Women Trial

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • instrumental delivery [ Time Frame: at labour ] [ Designated as safety issue: No ]
    The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections)


Secondary Outcome Measures:
  • start labour [ Time Frame: during labour ] [ Designated as safety issue: No ]
    start labour: spontaneous or induction

  • Oxytocin use [ Time Frame: During labour ] [ Designated as safety issue: No ]
    Oxytocin use registration during labour.

  • Duration ruptured membranes [ Time Frame: Labour ] [ Designated as safety issue: No ]
    Registration of duration of ruptured membranes

  • Internal digital vaginal examinations [ Time Frame: Labour ] [ Designated as safety issue: No ]
    Counting of the total amount of vaginal examinations untill delivery

  • Maternal fever [ Time Frame: During labour ] [ Designated as safety issue: No ]
    Defined as a temperature equal or above 38 degrees celsius.

  • Maternal antibiotic use [ Time Frame: During labour ] [ Designated as safety issue: No ]
  • Duration of second stage of labour [ Time Frame: labour ] [ Designated as safety issue: No ]
  • Obstetric complications [ Time Frame: labour ] [ Designated as safety issue: No ]
    For example hemorrhagia postpartum defined as > 1000 ml or third/ fourt degree perinael rupture, shoulder dystocia.

  • Epidural related complications [ Time Frame: labour and postpartum ] [ Designated as safety issue: No ]
    Epidural related complications, for example: bleeding, infection, postpunction headache.

  • Duration epidural [ Time Frame: labour ] [ Designated as safety issue: No ]
    The duration in hours of the epidural untill the delivery.

  • Maternal hypotension [ Time Frame: Labour ] [ Designated as safety issue: No ]
    Registration of the occurence of hypotension during labour.

  • Motor block [ Time Frame: Labour ] [ Designated as safety issue: No ]
    Motor block defined by the brommage score (only patients with epidural)

  • Other use of anaesthetics [ Time Frame: Labour ] [ Designated as safety issue: No ]
    Registration of the use of other used anaesthetics during labour.

  • Neonatal condition [ Time Frame: Postpartum ] [ Designated as safety issue: No ]
    Apgar, umbilical blood gasses.

  • Neonatal antibiotic use [ Time Frame: Postpartum ] [ Designated as safety issue: No ]
  • Neonatal admission [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • Maternal pain catastrophizing [ Time Frame: Antepartum ] [ Designated as safety issue: No ]
  • Beliefs about epidural [ Time Frame: antepartum ] [ Designated as safety issue: No ]
    Inventarisation of the beliefs about epidural analgesia

  • Maternal childbirth experience [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
    Inventarisation of the maternal childbirth experience

  • Quality of life [ Time Frame: antepartum, 6 weeks postpartum ] [ Designated as safety issue: No ]
    Inventarisation of the quality of life


Enrollment: 488
Study Start Date: September 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ropivacaine/sufentanil
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 Name: systemic opioids intramuscular and/or epidural analgesia

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261689

Locations
Netherlands
Atrium Medical Centre Parkstad
Heerlen, Limburg, Netherlands, 6419 PC
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01261689     History of Changes
Other Study ID Numbers: TREAT01
Study First Received: November 10, 2010
Last Updated: November 26, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
Epidural analgesia
Instrumental delivery
Maternal outcome
Neonatal outcome

Additional relevant MeSH terms:
Ropivacaine
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014