The Randomised Epidural Analgesia in Term Delivering Women Trial (TREAT) (TREAT)
|ClinicalTrials.gov Identifier: NCT01261689|
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : November 27, 2013
* 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 or disease||Intervention/treatment||Phase|
|Analgesia, Epidural Instrumental Delivery Maternal Outcome Neonatal Outcome||Drug: Ropivacaine/ Sufentanil according to local hospital protocol Other: Care-as usual pain treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Randomised Epidural Analgesia in Term Delivering Women Trial|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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
- instrumental delivery [ Time Frame: at labour ]The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections)
- start labour [ Time Frame: during labour ]start labour: spontaneous or induction
- Oxytocin use [ Time Frame: During labour ]Oxytocin use registration during labour.
- Duration ruptured membranes [ Time Frame: Labour ]Registration of duration of ruptured membranes
- Internal digital vaginal examinations [ Time Frame: Labour ]Counting of the total amount of vaginal examinations untill delivery
- Maternal fever [ Time Frame: During labour ]Defined as a temperature equal or above 38 degrees celsius.
- Maternal antibiotic use [ Time Frame: During labour ]
- Duration of second stage of labour [ Time Frame: labour ]
- Obstetric complications [ Time Frame: labour ]For example hemorrhagia postpartum defined as > 1000 ml or third/ fourt degree perinael rupture, shoulder dystocia.
- Epidural related complications [ Time Frame: labour and postpartum ]Epidural related complications, for example: bleeding, infection, postpunction headache.
- Duration epidural [ Time Frame: labour ]The duration in hours of the epidural untill the delivery.
- Maternal hypotension [ Time Frame: Labour ]Registration of the occurence of hypotension during labour.
- Motor block [ Time Frame: Labour ]Motor block defined by the brommage score (only patients with epidural)
- Other use of anaesthetics [ Time Frame: Labour ]Registration of the use of other used anaesthetics during labour.
- Neonatal condition [ Time Frame: Postpartum ]Apgar, umbilical blood gasses.
- Neonatal antibiotic use [ Time Frame: Postpartum ]
- Neonatal admission [ Time Frame: postpartum ]
- Maternal pain catastrophizing [ Time Frame: Antepartum ]
- Beliefs about epidural [ Time Frame: antepartum ]Inventarisation of the beliefs about epidural analgesia
- Maternal childbirth experience [ Time Frame: 6 weeks postpartum ]Inventarisation of the maternal childbirth experience
- Quality of life [ Time Frame: antepartum, 6 weeks postpartum ]Inventarisation of the quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261689
|Atrium Medical Centre Parkstad|
|Heerlen, Limburg, Netherlands, 6419 PC|
|Maastricht University Medical Centre|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Study Chair:||Jan Nijhuis, Prof. MD, PhD||Maastricht University Medical Center|
|Principal Investigator:||Martine Wassen, MD||Maastricht University Medical Center|