Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000494538
Ethics application status
Approved
Date submitted
2/03/2001
Date registered
2/03/2001
Date last updated
17/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture to induce labour
Scientific title
The influence of acupuncture on the induction of labour for women with a post date pregnancy: a randomised controlled trial.
Secondary ID [1] 23 0
Perinatal Trials Registry: PTR348
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women with a post date pregnancy 23 0
Condition category
Condition code
Reproductive Health and Childbirth 23 23 0 0
Normal pregnancy
Reproductive Health and Childbirth 24 24 0 0
Childbirth and postnatal care
Alternative and Complementary Medicine 25 25 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 (Treatment with acupuncture): women will receive a series of acupuncture treatment over a 1 hour period prior to their planned induction. Classical acupuncture points Hegu LI4, Sanyinjiao SP6, Shangliao UB31 and Ciliao UB2, Zusanli ST36, Taichong LR3 or alternative combinations will be used. Any underlying pathology such as deficiency of Blood or Qi, or stagnation of Qi and Blood will be examined, and treated, if appropriate.
Intervention code [1] 1096 0
Treatment: Other
Comparator / control treatment
Group 2 sham acupuncture points (body points which are not acupuncture points and away from classical acupuncture points) will be selected on the sacral area, hand, foot, a point below the knee and lower leg.
Control group
Placebo

Outcomes
Primary outcome [1] 46 0
Time of acupuncture treatment to the delivery of the baby
Timepoint [1] 46 0
The primary outcome measures specified a priori, related to the outcome of induction and were assessed by: a reduction in the need for prostaglandins, oxytocin and artifical rupture of membranes for induction of labour, measured following the birth of the baby.
Primary outcome [2] 47 0
Change in Bishops score from trial entry
Timepoint [2] 47 0
The primary outcome measures specified a priori, related to the outcome of induction and were assessed by: a reduction in the need for prostaglandins, oxytocin and artifical rupture of membranes for induction of labour, measured following the birth of the baby.

Measured following vaginal examination on admission to hospital.
Primary outcome [3] 48 0
Methods of pain relief
Timepoint [3] 48 0
The primary outcome measures specified a priori, related to the outcome of induction and were assessed by: a reduction in the need for prostaglandins, oxytocin and artifical rupture of membranes for induction of labour, measured following the birth of the baby.

Measured after birth of the baby and neonatal outcomes included incidence of fetal distress.
Primary outcome [4] 49 0
Mode of delivery
Timepoint [4] 49 0
The primary outcome measures specified a priori, related to the outcome of induction and were assessed by: a reduction in the need for prostaglandins, oxytocin and artifical rupture of membranes for induction of labour, measured following the birth of the baby.

Measured after birth of the baby and neonatal outcomes included incidence of fetal distress.
Primary outcome [5] 50 0
Length of active labour
Timepoint [5] 50 0
The primary outcome measures specified a priori, related to the outcome of induction and were assessed by: a reduction in the need for prostaglandins, oxytocin and artifical rupture of membranes for induction of labour, measured following the birth of the baby.

Measured after birth of the baby and neonatal outcomes included incidence of fetal distress.
Primary outcome [6] 51 0
Apgar scores <7 at 5 minutes
Timepoint [6] 51 0
The primary outcome measures specified a priori, related to the outcome of induction and were assessed by: a reduction in the need for prostaglandins, oxytocin and artifical rupture of membranes for induction of labour, measured following the birth of the baby.

Measured after the birth of the baby.
Primary outcome [7] 52 0
Rooming in of infant with mother
Timepoint [7] 52 0
The primary outcome measures specified a priori, related to the outcome of induction and were assessed by: a reduction in the need for prostaglandins, oxytocin and artifical rupture of membranes for induction of labour, measured following the birth of the baby.

Measured after admission of the mother to postnatal ward.
Secondary outcome [1] 71 0
Meconium stained amniotic fluid
Timepoint [1] 71 0
Secondary outcomes were measured following delivery and following discharge of the mother and baby.
Secondary outcome [2] 72 0
Fetal heart rate abnormalities in labour
Timepoint [2] 72 0
Measured following the birth of the baby.
Secondary outcome [3] 73 0
Neonatal jaundice requiring phototherapy
Timepoint [3] 73 0
Secondary outcomes were measured following delivery and following discharge of the mother and baby.
Secondary outcome [4] 74 0
Neonatal seizures
Timepoint [4] 74 0
Secondary outcomes were measured following delivery and following discharge of the mother and baby.
Secondary outcome [5] 75 0
Length of neonatal nursery stay
Timepoint [5] 75 0
Measured on discharge of the baby.
Secondary outcome [6] 76 0
Birthing centre delivery
Timepoint [6] 76 0
Measured after delivery of the baby.

Eligibility
Key inclusion criteria
Women > or = 41 weeks booked for delivery at Women's and Children's Hospital; singleton pregnancy; cephalic presentation; informed written consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Active labour (cervix fully effaced > or = 3cm dilated) and regular uterine contractions; contra-indications to induction of labour or vaginal delivery; women with spontaneous premautre rupture of membranes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher developed the computer generated randomization schedule with variable block size and stratification by parity (nulliparous and multiparous)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects are blind in this study. Data was collected by researchers not involved with the administration of the trial intervention and the analysis was carried out by an independent statistician blind to the woman’s study group.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
404
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 33 0
Government body
Name [1] 33 0
National Health and Medial Research Council
Country [1] 33 0
Australia
Funding source category [2] 4160 0
Government body
Name [2] 4160 0
NHMRC
Country [2] 4160 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Dept Obstetrics and Gynaecogy
North Terrace
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 30 0
None
Name [1] 30 0
Nil
Address [1] 30 0
Country [1] 30 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 285 0
Women's & Children's Hospital
Ethics committee address [1] 285 0
Ethics committee country [1] 285 0
Australia
Date submitted for ethics approval [1] 285 0
Approval date [1] 285 0
01/04/1998
Ethics approval number [1] 285 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36178 0
Address 36178 0
Country 36178 0
Phone 36178 0
Fax 36178 0
Email 36178 0
Contact person for public queries
Name 10285 0
Caroline Smith
Address 10285 0
2 The Parade
Norwood SA 5065
Country 10285 0
Australia
Phone 10285 0
0419390755
Fax 10285 0
Email 10285 0
[email protected]
Contact person for scientific queries
Name 1213 0
Caroline Smith
Address 1213 0
2 The Parade Norwood SA 5061
Country 1213 0
Australia
Phone 1213 0
08 8382 6622
Fax 1213 0
Email 1213 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.