NCT00611221

Brief Summary

OBJECTIVE: To measure the benefits of massage, administered by a registered massage therapist, to pain management for women in active labour. DESIGN: A randomized controlled trial. SETTING: BC Women's Hospital, a tertiary level maternity teaching hospital in Vancouver, British Columbia, Canada. PARTICIPANTS: Healthy first time mothers experiencing an uncomplicated pregnancy who present to the hospital in labour. Seventy women will be enrolled in each trial arm. MAIN OUTCOME MEASURES: The primary outcome is time to use of epidural analgesia measured as cervical dilatation at the time of epidural insertion. Secondary outcomes include use of epidural and narcotic analgesia, and measures of intensity and characteristics of pain. DATA ANALYSIS: Study outcomes will be compared among women randomized to receive a maximum of five hours of massage during labour administered by a registered massage therapist versus usual care. Analysis will be by intention to treat. Prognostics factors not balanced between trial arms (massage and usual care) will be controlled for in a multivariate analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 27, 2011

Status Verified

April 1, 2011

Enrollment Period

1.3 years

First QC Date

January 28, 2008

Last Update Submit

April 26, 2011

Conditions

Pain During Labour

Keywords

massagelabour

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is time to use of epidural analgesia measured as cervical dilatation at the time of epidural insertion.

    During labour

Secondary Outcomes (1)

  • Secondary outcomes include use of epidural and narcotic analgesia and measures of intensity and characteristics of pain.

    During labour

Study Arms (2)

1

ACTIVE COMPARATOR

Massage therapy by a regulated massage therapist

Procedure: Massage

2

ACTIVE COMPARATOR

Massage by anyone else, eg. husband, nurse, doula

Procedure: Massage

Interventions

MassagePROCEDURE

Massage therapy by an RMT during labour

1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy primiparous women
  • Nulliparous
  • Singleton gestation
  • Cephalic presentation
  • Term gestation (37-41 completed weeks of pregnancy)
  • Maternal age between 18 and 35 years of age
  • In spontaneous labour, defined for our purposes as painful contractions which have resulted in cervical change, i.e. cervix is 1 cm dilated or more with effacement at 25% (0.5 cm) or more on admission to the labour unit
  • Able to speak and read English or speak a language for which there is a nursing interpreter available

You may not qualify if:

  • Pre-existing medical conditions including but not limited to: insulin dependent diabetes, renal, cardiac, or thyroid conditions, hypertension, epilepsy, psychosis, use of illicit street drugs
  • Conditions arising during pregnancy which require non-routine surveillance and/or intervention including but not limited to gestational diabetes, gestational hypertension, 2nd or 3rd trimester hemorrhage, intrauterine growth restriction, presence of a fetal congenital anomaly, history of preterm prelabour rupture of membranes
  • Statement by women on admission that she has been in labour for more than 24 hours
  • Cervical dilatation 10 cm (full dilatation) on admission to the labour ward

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Patricia Janssen, Ph.D

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 27, 2011

Record last verified: 2011-04

Locations

CA(1)