ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

Gestational weight gain for obese women as defined by the Institute of Medicine.

Timepoint [1]

Weight at booking visit (<17 weeks gestation) and weight at or after 36 weeks (last weight recorded prior to birth).

Secondary outcome [1]

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]

An audit of participants' pregnancy records after birth will assess whether or not standards of care have been achieved.

Secondary outcome [2]

Women's satisfaction with care

Timepoint [2]

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]

University

Name [1]

Deakin University

Address [1]

Waterfront Campus
1 Gheringhap St
Geelong
Victoria
3217

Country [1]

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]

Individual

Name [1]

Dr Helen Skouteris

Address [1]

Deakin University
School of Psychology
221 Burwood Hwy
Burwood
Victoria
3125

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health

Ethics committee address [1]

5 Arnold St
Box Hill
Victoria
3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/10/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Cate Nagle

Address

Deakin University
School of Nursing and Midwifery
Geelong Waterfront Campus
Geelong
Victoria
3217

Country

Australia

Phone

+61 3 5227 8401

Fax

+61 3 5227 8411

cate.nagle@deakin.edu.au

Contact person for scientific queries

Name

Dr Cate Nagle

Address

Deakin University
School of Nursing and Midwifery
Geelong Waterfront Campus
Geelong
Victoria
3217

Country

Australia

Phone

+61 3 5227 8401

Fax

+61 3 5227 8411

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically