Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001078044
Ethics application status
Approved
Date submitted
5/12/2010
Date registered
8/12/2010
Date last updated
8/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of continuity of care on weight gain in obese pregnant women
Scientific title
In obese pregnant women, does continuity of care compared to usual care prevent excessive gestational weight gain?
Secondary ID [1] 253239 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational weight gain (as defined by the Institute of Medicine) for women whose BMI is >/=30 258773 0
Condition category
Condition code
Reproductive Health and Childbirth 258916 258916 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuity of care can be defined as care that is provided by the same clinician or small group of clinicians throughout pregnancy, birth and the postnatal period.
In this study, continuity of care will be understood as the provision of care within a continiuty of care model where pregnancy care is provided to the woman by a limited number of midwives and doctors. Models will vary between maternity services but for all sites care will be limited to no more than three midwives and no more than two obsterticians for the duration of the pregnancy.
Intervention code [1] 257708 0
Prevention
Intervention code [2] 257722 0
Other interventions
Comparator / control treatment
Routine pregnancy care or 'usual care' and this may involve care within any number of models available at the recruitment sites including, but not restricted to, clinic care (the woman may be seen by different midwives and doctors each visit) or shared care (the woman may be seen by her General Practitioner and when she attends the hopsital she may be seen by different clinic staff each visit).
Women in both the intervention and control group will recieve an information booklet.
Control group
Active

Outcomes
Primary outcome [1] 259782 0
Gestational weight gain for obese women as defined by the Institute of Medicine.
Timepoint [1] 259782 0
Weight at booking visit (<17 weeks gestation) and weight at or after 36 weeks (last weight recorded prior to birth).
Secondary outcome [1] 268559 0
Pregnancy care consisitent with the 2010 guidelines for management of women with obesity in pregnancy developed by the Centre for Maternal and Child Enquires and the Royal College of Obstetricians and Gynaecologists.
Timepoint [1] 268559 0
An audit of participants' pregnancy records after birth will assess whether or not standards of care have been achieved.
Secondary outcome [2] 268560 0
Women's satisfaction with care
Timepoint [2] 268560 0
A survey administered to participants at 36 weeks gestation

Eligibility
Key inclusion criteria
Pregnant women with a BMI>/=30 and are < 17 weeks gestation at the booking in appointment
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to give informed consent in English; have a multiple pregnancy; currently experiencing vaginal bleeding.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will offered information on the study and participation in the trial by the attending midwife or doctor following the measurement of their BMI at the booking in visit. The attending clinicians will not be a part of the study team. Women agreeing to participate will provide written consent prior to randomisation.
Sealed in opaque envelopes will be numbered and drawn in consecutive order by the attending clinician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will occur, with a computerised randomisation sequence for each recruitment site generated by a person independent of the research team.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
214
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258175 0
University
Name [1] 258175 0
Deakin University
Country [1] 258175 0
Australia
Primary sponsor type
Individual
Name
Dr Cate Nagle
Address
Deakin University
School of Nursing and Midwifery
Waterfront Campus
1 Gheringhap St
Geelong
Victoria
3217
Country
Australia
Secondary sponsor category [1] 257350 0
Individual
Name [1] 257350 0
Dr Helen Skouteris
Address [1] 257350 0
Deakin University
School of Psychology
221 Burwood Hwy
Burwood
Victoria
3125
Country [1] 257350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260165 0
Eastern Health
Ethics committee address [1] 260165 0
5 Arnold St
Box Hill
Victoria
3128
Ethics committee country [1] 260165 0
Australia
Date submitted for ethics approval [1] 260165 0
Approval date [1] 260165 0
29/10/2010
Ethics approval number [1] 260165 0
E19/1011

Summary
Brief summary
Obesity in pregnancy has increased to epidemic proportions in developed countries. It is associated with adverse outcomes for both mother and child. Maternal risks for hypertensive disorders, gestational diabetes, thrombo-embolism, haemorrhage, infections and death are increased in obese women and there are attendant risks and resourcing issues associated with obesity and childbirth. Compared to women who have a BMI between 20.1- 25, obese women are more likely to experience: increased rates of induction of labour and failed induction; anaesthetic difficulties; caesarean section; a stay in hospital of more than five days and obese women require specific equipment for accurate monitoring and safe maternity care. The risks of adverse outcomes for fetuses and neonates are also increased
While there is limited evidence to support the effectiveness of dietary and physical activity lifestyle interventions in preventing excessive gestational weight gain, the American Institute of Medicine (IOM) published revised guidelines (2009) on how much weight a woman should gain during pregnancy and highlighted the importance of intervention in pregnancy to prevent both postpartum weight retention and childhood obesity. The American IOM recommends that pregnant women who are obese (BMI >/= 30 ) should gain 5 to 9 kg. Excessive gestational weight gain is defined as weight gain above this recommended guideline.
Maternity reform at both Australian federal and state levels of government promote the benefits of continuity of care to women at low risk of complications and the expanded role of midwives working collaboratively in multidisciplinary teams. Continuity of care can be defined as care that is provided by the same clinician or small group of clinicians throughout pregnancy, birth and the postnatal period. Continuity of care can empower women and promotes participation in their care improve the sense of control women perceive, and improve satisfaction with care. However the impact of continuity of care as an intervention to improve outcomes for women who are obese has not been explored.
The primary aim of this trial is to measure the impact of continuity of care in preventing excessive gestational weight gain in obese women. Following the calculation of their BMI at the booking in visit, women with a BMI>/=30 and meeting the additional selection criteria will be provided with written information about this project by the attending midwife or doctor (not members of the study group) and invited to participate. Women will be given time to answer questions and to provide written informed consent. Women agreeing to participate will be randomised to receive continuity of care (intervention) or routine care (control group). Women in both group will receive an information booklet on restricting gestation weight gain for women with a BMI>/= 30.
A secondary aim of the study is to measure the impact of continuity of care on obese women receiving evidenced based care as defined by the 2010 guidelines for management of women with obesity in pregnancy developed by the Centre for Maternal and Child Enquires and the Royal College of Obstetricians and Gynaecologists. An audit of participants’ pregnancy records after birth will assess whether or not standards of care have been achieved. Information will also be obtained on participants’ demographics, previous pregnancies, medical problems, interventions for labour and birth, mode of birth and baby’s weight at birth.
Another secondary aim is women’s satisfaction with care. Participants will complete two surveys, one at recruitment and another at 36 weeks gestation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31990 0
Address 31990 0
Country 31990 0
Phone 31990 0
Fax 31990 0
Email 31990 0
Contact person for public queries
Name 15237 0
Dr Cate Nagle
Address 15237 0
Deakin University
School of Nursing and Midwifery
Geelong Waterfront Campus
Geelong
Victoria
3217
Country 15237 0
Australia
Phone 15237 0
+61 3 5227 8401
Fax 15237 0
+61 3 5227 8411
Email 15237 0
cate.nagle@deakin.edu.au
Contact person for scientific queries
Name 6165 0
Dr Cate Nagle
Address 6165 0
Deakin University
School of Nursing and Midwifery
Geelong Waterfront Campus
Geelong
Victoria
3217
Country 6165 0
Australia
Phone 6165 0
+61 3 5227 8401
Fax 6165 0
+61 3 5227 8411
Email 6165 0
cate.nagle@deakin.edu.au

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
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Documents added automatically
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