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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01261689
Other study ID # TREAT01
Secondary ID
Status Completed
Phase N/A
First received November 10, 2010
Last updated November 26, 2013
Start date September 2008
Est. completion date November 2013

Study information

Verified date November 2013
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical 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.

* 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 488
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Drug:
Ropivacaine/ Sufentanil according to local hospital protocol
according to local hospital protocol
Other:
Care-as usual pain treatment
Pain treatment only on request of the women in labour. Treatment is given according to local hospital protocol.

Locations

Country Name City State
Netherlands Atrium Medical Centre Parkstad Heerlen Limburg
Netherlands Maastricht University Medical Centre Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary instrumental delivery The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections) at labour No
Secondary start labour start labour: spontaneous or induction during labour No
Secondary Oxytocin use Oxytocin use registration during labour. During labour No
Secondary Duration ruptured membranes Registration of duration of ruptured membranes Labour No
Secondary Internal digital vaginal examinations Counting of the total amount of vaginal examinations untill delivery Labour No
Secondary Maternal fever Defined as a temperature equal or above 38 degrees celsius. During labour No
Secondary Maternal antibiotic use During labour No
Secondary Duration of second stage of labour labour No
Secondary Obstetric complications For example hemorrhagia postpartum defined as > 1000 ml or third/ fourt degree perinael rupture, shoulder dystocia. labour No
Secondary Epidural related complications Epidural related complications, for example: bleeding, infection, postpunction headache. labour and postpartum No
Secondary Duration epidural The duration in hours of the epidural untill the delivery. labour No
Secondary Maternal hypotension Registration of the occurence of hypotension during labour. Labour No
Secondary Motor block Motor block defined by the brommage score (only patients with epidural) Labour No
Secondary Other use of anaesthetics Registration of the use of other used anaesthetics during labour. Labour No
Secondary Neonatal condition Apgar, umbilical blood gasses. Postpartum No
Secondary Neonatal antibiotic use Postpartum No
Secondary Neonatal admission postpartum No
Secondary Maternal pain catastrophizing Antepartum No
Secondary Beliefs about epidural Inventarisation of the beliefs about epidural analgesia antepartum No
Secondary Maternal childbirth experience Inventarisation of the maternal childbirth experience 6 weeks postpartum No
Secondary Quality of life Inventarisation of the quality of life antepartum, 6 weeks postpartum No
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