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Trial registered on ANZCTR


Registration number
ACTRN12611001214921
Ethics application status
Not yet submitted
Date submitted
22/11/2011
Date registered
24/11/2011
Date last updated
24/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to determine whether continuity of care increases the rate of attempted vaginal birth after caesarean (VBAC)
Scientific title
A randomised controlled trial to determine whether midwifery continuity of care increases the rate of attempted vaginal birth for women with a previous caesarean section.
Secondary ID [1] 273433 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal birth after caesarean section 279217 0
Condition category
Condition code
Reproductive Health and Childbirth 279423 279423 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention–Midwifery continuity of care: Women allocated to the intervention group will receive midwifery continuity of care from a small group of midwives. The midwives will provide care during the antenatal, labour and birth, and postnatal periods (to two weeks postnatally). Midwives will adhere to The National Midwifery Guidelines for Consultation & Referral. All women will have an appointment with an obstetric consultant at 36 weeks gestation (to re-assess VBAC suitability and discuss the birth plan). If a woman develops complications during pregnancy and requires additional care, she will continue with the midwifery continuity of care model while also attending obstetric or other consultations (this is the same for both groups). Labour and birth care will be provided at Gosford Hospital Birth Unit and postnatal care will be provided in the woman’s own home for a period of two weeks postpartum, following discharge from hospital.
Intervention code [1] 283764 0
Other interventions
Intervention code [2] 283771 0
Treatment: Other
Comparator / control treatment
Control–Standard Care: Women allocated to the control group will receive the current model of public maternity care at Gosford Hospital. Antenatal care is provided by antenatal staff (midwives and obstetricians). Staff in the Birth Unit provide labour and birth care and postnatal care is provided by midwives in the postnatal ward. Women are also offered midwifery visits at home for up to two weeks following discharge from hospital (4–48 hours after a vaginal birth). All these care providers are different people.
Control group
Active

Outcomes
Primary outcome [1] 285993 0
Proportion of women who attempt vaginal birth in their current pregnancy
Timepoint [1] 285993 0
At the end of labour and birth
Secondary outcome [1] 294914 0
Proportion of vaginal births
Timepoint [1] 294914 0
At the end of labour and birth
Secondary outcome [2] 294915 0
Neonatal health will be assessed at birth and at 28 days (Apgar scores, admisison to special care nursery, length of stay in hospital, readmission to hospital).
Timepoint [2] 294915 0
28 days
Secondary outcome [3] 294916 0
Improves women's social and emotional outcomes examined using a survey at 36 weeks of pregnancy and at 6 weeks postpartum
Timepoint [3] 294916 0
During pregnancy, and after 6-8 weeks

Eligibility
Key inclusion criteria
Booking-in visit attended no later than 20 weeks; most recent birth was by lower-segment CS; no more than one previous CS; considered low risk, other than a history of previous CS; no other previous uterine incision; no previous uterine rupture; no contraindications for vaginal birth at the time of enrolment; English proficiency (spoken and written); public patient; and, no known preference for a certain model of care, such as GP-shared care
Minimum age
16 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications for vaginal birth at the time of enrolment
Not willing to receive model of care

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)
Randomisation will be 1:1 and stratified for spontaneous labour in the primary CS, that is whether the woman had a labour or not prior to her primary CS.

Allocation concealment will be assured by using a central remote telephone allocation service which will ensure that the person determining eligibility will not be aware as to the group that the participant will be allocated. The RA will telephone the allocation service to provide the woman’s initials and date of birth. The allocation service will check her eligibility. The midwife will be informed of the group to which the woman has been allocated and will receive her study number, which will be recorded in the Trial Register and Log Book. If allocated to standard care, the woman will be advised of her next clinic appointment. If allocated to midwifery continuity of care, she will be advised of the time and place of her first visit with the midwifery continuity of care practice.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A remote telephone allocation service will assist with generation of the sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284240 0
Government body
Name [1] 284240 0
NHMRC Project Grant
Address [1] 284240 0
18 Marcus Clarke Street
Canberra ACT 2600
Country [1] 284240 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
PO Box 123
Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 269196 0
Hospital
Name [1] 269196 0
Gosford Hospital
Address [1] 269196 0
Holden Street
GOSFORD NSW 2519
Country [1] 269196 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286205 0
Ethics committee address [1] 286205 0
Ethics committee country [1] 286205 0
Date submitted for ethics approval [1] 286205 0
30/01/2012
Approval date [1] 286205 0
Ethics approval number [1] 286205 0

Summary
Brief summary
Pregnancy and birth directly affect almost 300,000 families in Australia each year. A key concern is that the caesarean section rate in Australia is higher than similar countries with a lack of support for women to have a vaginal birth after caesarean section.

We plan to undertake a trial to determine whether midwifery continuity of care increases the rate of vaginal birth in women who have had a previous caesarean section. This trial could significantly alter the way maternity care is provided.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 33422 0
Address 33422 0
Country 33422 0
Phone 33422 0
Fax 33422 0
Email 33422 0
Contact person for public queries
Name 16669 0
Caroline Homer
Address 16669 0
UTS
PO Box 123
Broadway NSW 2007
Country 16669 0
Australia
Phone 16669 0
+61 2 9514 4834
Fax 16669 0
+61 2 9514 4835
Email 16669 0
caroline.homer@uts.edu.au
Contact person for scientific queries
Name 7597 0
Caroline Homer
Address 7597 0
UTS
PO Box 123
Broadway NSW 2007
Country 7597 0
Australia
Phone 7597 0
+61 2 9514 4834
Fax 7597 0
+61 2 9514 4835
Email 7597 0
caroline.homer@uts.edu.au

No data has been provided for results reporting
Summary results
Not applicable