The Randomised Epidural Analgesia in Term Delivering Women Trial (TREAT) (TREAT)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|