Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00611221 |
| Other study ID # |
H07-00528 |
| Secondary ID |
CW07-0090 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
January 28, 2008 |
| Last updated |
April 26, 2011 |
| Start date |
January 2008 |
| Est. completion date |
May 2009 |
Study information
| Verified date |
April 2011 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Health Canada |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Goal and Objectives:
The overall purpose of this project is to evaluate the effectiveness of massage therapy
provided by registered massage therapists in managing pain among women in active labour.
Specific Aims:
Our specific aim is to randomly assign women admitted to hospital in active labour to
receive a maximum of five hours massage by a regulated massage therapist or usual care in
order to study the effect of massage therapy on pain relief, labour management and patient
outcomes.
Research Questions:
We will compare among healthy, nulliparous women experiencing health pregnancies with access
to massage therapy after admission to hospital in active labour vs. women receiving usual
care:
- the severity and quality of pain from contractions
- among women carrying a fetus in the occiput posterior position, the severity of back
pain
- length of first and second stage of labour
- need for use of entonox, sterile water injections, intravenous or intramuscular
narcotics, and epidural analgesia
- stage of labour (cervical dilatation) among those women who receive epidural analgesia
- position of occiput at the onset of second stage
- mode of delivery: spontaneous vaginal, assisted (vacuum/forceps), and caesarean section
- time to first breastfeeding after delivery
Hypotheses:
We hypothesize that healthy women who receive massage therapy during active labour will:
- at a given cervical dilatation, experience less severe pain with contractions
- if carrying a fetus in the occiput posterior position, at a given cervical dilatation,
will report less severe back pain
- experience a shorter first and second stage of labour
- be more likely to request entenox
- be more likely to request sterile water injections
- be more likely to request intravenous or intramuscular narcotics
- be less likely to request epidural analgesia
- if requesting epidural analgesia, to request it at a later stage (greater cervical
dilatation) in labour
- The fetal occiput will be more likely to be anterior vs. posterior at the onset of
second stage of labour
- be less likely to deliver by caesarean section
- undertake their first breastfeeding more quickly after delivery
Design:
We propose a randomized two-arm unblinded controlled trial. The treatment condition is
massage therapy during the active phase of labour by a registered massage therapist. The
control condition is usual care. The primary outcome is cervical dilatation at request for
epidural analgesia.
Study sample:
Our study sample will be drawn from healthy nulliparous women experiencing healthy
pregnancies presenting for intrapartum care at BC Women's Hospital.
Study Setting:
The study will take place at BC Women's Hospital in Vancouver, British Columbia, Canada. BC
Women's is an academic teaching hospital. It provides primary care to women who are
residents of the City of Vancouver, regional referral care to residents of the Lower
Mainland or southwest corner of the province, and tertiary referral care for the entire
province. Approximately 7500 take place at this hospital annually; about 7000 are to women
who reside in Vancouver. All women for whom delivery is not imminent are triaged in a large
assessment room adjacent to the delivery suite prior to being admitted for intrapartum care.
Women in labour have one-to-one care in a private labour room. They may have whomever else
they want in the room to support them.
Recruitment:
Women will be approached for participation in the study by a registered, experienced
obstetrical nurse on admission to the assessment area of the hospital. At present, this
service is provided by the Maternal/fetal Medicine Division of the Department of Obstetrics
and Gynecology, for a fee.
Randomization:
Randomization will take place immediately after obtaining written consent. A statistical
software package (SPSS - Statistical Program for the Social Sciences) will be utilized to
randomly assign sequential numbers to one of the two treatment arms. Cards will be numbered
sequentially and labelled with the treatment allocation. These cards will be placed in
opaque envelopes in a box which will be kept in a locked cupboard to which the recruitment
nurse holds the key. Envelopes will be opened in sequential order for each study participant
after written informed consent has been obtained. A log book will be maintained by the
recruitment nurse detailing the patients approached, their decision to participate or not,
randomization number, and allocation.
Protocol:
Immediately after randomization, the recruitment nurse will contact the massage therapist on
call by means of a cell phone. Massage therapists named in this application have agreed to
be on call for the study for periods in total that cover 7 days per week. The massage
therapist will leave immediately to come and provide massage therapy. The massage therapist
will receive a brief report from the women's labour and delivery nurse as to what nature of
the woman's labour to that point. She will then explain to the women what she would suggest
for specific massage techniques and will begin as soon as the woman is ready. It should be
noted that women may continue to use other non-invasive pain management modalities as they
wish. This is a pragmatic trial in that massage therapy is seen as one additional choice
that women will have access to in addition to the repertoire of choices that are routinely
available.
Study Outcomes:
Our primary outcome is timing of epidural analgesia with respect to cervical dilatation.
This outcome is chosen because 67% of nulliparous women at this institution have epidural
analgesia and because of the association of epidural use with intrapartum interventions. In
the current study we would like to be able to detect a mean decrease in cervical dilation at
the time of request for epidural as small as 1 cm. In order to find a decrease of 1 cm in
cervical dilation, which is a clinically important difference, we would need 42 study
subjects per group with 80% power and a type I error set at p =.05, one sided. Since we
learned from our previous study that 61% of women meeting study inclusion criteria receive
an epidural prior to 10 cm dilatation, we know that we will have to recruit 70 women per
study arm to have 42 people in each arm who receive an epidural.
