NCT01261689

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

5.2 years

First QC Date

November 10, 2010

Last Update Submit

November 26, 2013

Conditions

Analgesia, EpiduralInstrumental DeliveryMaternal OutcomeNeonatal Outcome

Keywords

Epidural analgesiaInstrumental deliveryMaternal outcomeNeonatal outcome

Outcome Measures

Primary Outcomes (1)

  • instrumental delivery

    The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections)

    at labour

Secondary Outcomes (20)

  • start labour

    during labour

  • Oxytocin use

    During labour

  • Duration ruptured membranes

    Labour

  • Internal digital vaginal examinations

    Labour

  • Maternal fever

    During labour

  • +15 more secondary outcomes

Study Arms (2)

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.

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.

Other: Care-as usual pain treatment

Interventions

Ropivacaine/ Sufentanil according to local hospital protocolDRUG

according to local hospital protocol

Also known as: ropivacaine/sufentanil
Epidural analgesia
Care-as usual pain treatmentOTHER

Pain treatment only on request of the women in labour. Treatment is given according to local hospital protocol.

Also known as: systemic opioids intramuscular and/or epidural analgesia
Care as-usual pain treatment

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • be younger than 18 years
  • bear twin pregnancy
  • have contraindications for vaginal labour
  • have contraindications for EA
  • referral by midwife during labour (first line)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atrium Medical Centre Parkstad

Heerlen, Limburg, 6419 PC, Netherlands

Location

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related 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.

    PMID: 21392241BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

RopivacaineSufentanil

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jan Nijhuis, Prof. MD, PhD

    Maastricht University Medical Center

    STUDY CHAIR

  • Martine Wassen, MD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2010

First Posted

December 16, 2010

Study Start

September 1, 2008

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

NL(2)