Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000331033
Ethics application status
Approved
Date submitted
4/04/2010
Date registered
23/04/2010
Date last updated
23/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Weighing In Pregnancy
Scientific title
In antenatal women, does weighing at each visit compared with routine antenatal care reduce the incidence of excessive weight gain during pregnancy?
Secondary ID [1] 251643 0
None
Universal Trial Number (UTN)
Trial acronym
WIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight gain above the World Health Organisation and Institute of Medicine recommendations during pregnancy. 256915 0
Condition category
Condition code
Reproductive Health and Childbirth 257374 257374 0 0
Antenatal care
Diet and Nutrition 257375 257375 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
weighing will be included in the routine antenatal check at each visit. The number and length of the antenatal visits will remain routine ie 10 visits in the pregnancy at 15 to 30minute consults.
Intervention code [1] 256111 0
Prevention
Intervention code [2] 256355 0
Other interventions
Comparator / control treatment
Routine antenatal care.

This involves a visit each 4 weeks unless otherwise indicted and a visit every 2 weeks once >36weeks gestation. In this visit the pregnancy is discussed, the symphysio-fundal height is measured, fetal doppler is performed and the mothers concerns or questions are answered.
Control group
Active

Outcomes
Primary outcome [1] 257955 0
Weight gain within the ideal range according to the American Institute of Medicine (IOM) and the World Health Organisation (WHO) recommendations
Timepoint [1] 257955 0
>36 weeks gestation (last weight prior to delivery >36weeks)
Secondary outcome [1] 263483 0
for the mother:
o medical complications of pregnancy ie Pre-eclampsia or eclampsia, hypertension, gestational diabetes

Determined by blood pressure (BP), urine analysis and full blood exam (FBE) and electrolytes, urea and Creatinine (EUC), blood sugar level (BSL), liver function tests (LFT)
Timepoint [1] 263483 0
weekly upto 6 weeks postpartum
Secondary outcome [2] 263953 0
o Need for an induction of labour

We will review the notes post delivery
Timepoint [2] 263953 0
At delivery
Secondary outcome [3] 263954 0
for the mother:
o Mode of birth (vaginal vs instrumental vs Caesarean section)

We will review the notes post delivery
Timepoint [3] 263954 0
At delivery
Secondary outcome [4] 263955 0
for the mother:
o Post partum complication: Post partum hemorrhage, wound infection, need for antibiotics, endometritis, perineal trauma, thromboembolic disease, death

Determined by blood loss, FBE, vaginal swabs and review of the notes
Timepoint [4] 263955 0
weekly for upto 6weeks postpartum
Secondary outcome [5] 263956 0
for the mother:
o Breast feeding

We will review the notes post delivery to see if the mother is breast feeding or using formular
Timepoint [5] 263956 0
weekly upto 6weeks post partum
Secondary outcome [6] 263957 0
fetal/neonatal
o birth weight

Using scales
Timepoint [6] 263957 0
at delivery
Secondary outcome [7] 263958 0
fetal/neonatal
o complications relating to macrosomia including hypoglycemia, hyperbilirubinemia, shoulder dystocia, infant birth trauma (palsy, fracture)

infant BSL, LFT, and review of the notes
Timepoint [7] 263958 0
weekly upto 6 weeks postpartum
Secondary outcome [8] 263959 0
Fetal/neonatal
o admission to Speacial Care Nursery (SCN) / Neonatal Intensive Care Unit (NICU)
Timepoint [8] 263959 0
weekly upto 6 weeks postpartum

We will review the notes post delivery

Eligibility
Key inclusion criteria
Pregnant women at < 20 weeks gestation.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Multiple gestation
Extremes of reproductive age (<18 or >45years)
Medical complicating factors at booking (including thyroid disease, diabetes (type 1 or 2), psychiatric illness etc)
Substance abuse
First antenatal visit >20weeks gestation
Intention to complete antenatal care through another clinic
Intention to have shared care
Unable to understand English

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 meeting the inclusion criteria will be approached during their first antenatal visit by their treating midwife or doctor who will explain the study, give possible participants an information sheet that will outline the study and expected weight gain and consent the patient with forms approved by The Royal Women’s Hospital Research Committee. The treating doctor or midwife approaching the patient will not be directly involved in the research project. Once recruited she will be allocated an opaque envelope that will place the patient in either the intervention group or the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The seqeuence is computer generated. It is then placed into sealed opaque envelopes which are selected on randomisation of a patient.
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
Recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256607 0
Self funded/Unfunded
Name [1] 256607 0
Fiona Brownfoot
Country [1] 256607 0
Australia
Primary sponsor type
Individual
Name
Fiona Brownfoot
Address
The Royal Women's Hospital.
Grattan St & Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 255898 0
Individual
Name [1] 255898 0
Assoicate Professor Louise Kornman
Address [1] 255898 0
The Royal Women's Hospital.
Grattan St & Flemington Rd
Parkville VIC 3052
Country [1] 255898 0
Australia
Other collaborator category [1] 1145 0
Individual
Name [1] 1145 0
Associate Professor Louise Kornman
Address [1] 1145 0
The Royal Women's Hospital.
Grattan St & Flemington Rd
Parkville VIC 3052
Country [1] 1145 0
Australia
Other collaborator category [2] 1186 0
Individual
Name [2] 1186 0
Jinlin Wang
Address [2] 1186 0
The Royal Women's Hospital.
Grattan St & Flemington Rd
Parkville VIC 3052
Country [2] 1186 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258637 0
The Royal Women's Hospital Research and human research ethics committee
Ethics committee address [1] 258637 0
The Royal Women's Hospital.
Grattan St & Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 258637 0
Australia
Date submitted for ethics approval [1] 258637 0
01/07/2009
Approval date [1] 258637 0
31/07/2009
Ethics approval number [1] 258637 0
RWH PROJECT NUMBER 09/28

Summary
Brief summary
Overweight and obesity are the most common clinical risk factors affecting over 30% of the pregnancy population. Furthermore, excessive weight gain while pregnant also leads to increased morbidity and mortality for the woman and the fetus/neonate. The morbidity includes, for the fetus/neonate: macrosomia, shoulder dystocia, hypoglycemia and admission to the nursery and for the mother: high blood pressure, gestational diabetes, increased caesarean section rates and increased rates of overweight and obesity post pregnancy. A number of studies have targeted diet and exercise with varied effect. No study has focused on routinely weighing patients in clinic to provide regular feedback that may act as a positive behavioural component to limit weight gain.

This study will investigate the effect of weighing pregnant patients at each antenatal clinic visit compared with routine care (weight recorded at the booking visit). All patients attending the Royal Women’s Hospital for their booking visit (<20weeks gestation) will be approached by a midwife or doctor. Only women planning to have all their antenatal care at the Royal Women's Hospital, and with no obvious medical problems, will be included. Once consented, patients will then be randomised into either the control or the intervention groups. Patients in the intervention group will be weighed at every antenatal visit until 36-38 weeks gestation, while the control group will receive routine care with a booking weight plus a weight at 36-38 weeks gestation. Information will be obtained about their demographics, previous pregnancies, medical problems and delivery. Participants will complete a questionnaire at the end of the study regarding their perception of being weighed.

We will then analyse the mean pregnancy weight gain of the intervention group compared to the control group. We will also analyse the data according to the Body Mass Index (BMI) at entry to determine if particular subgroups of women (ie underweight, normal weight, overweight and obese) appear to have a different response to being weighed. We will also compare the neonatal outcomes to ensure there is no obvious harm in the process of regular weighing.

This study will allow us to determine if weighing patients regularly does provide a positive behavioural component resulting in appropriate weight gain in pregnancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30902 0
Address 30902 0
Country 30902 0
Phone 30902 0
Fax 30902 0
Email 30902 0
Contact person for public queries
Name 14149 0
Fiona Brownfoot
Address 14149 0
The Royal Women's Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country 14149 0
Australia
Phone 14149 0
61 3 83452000
Fax 14149 0
Email 14149 0
fiona.brownfoot@thewomens.org.au
Contact person for scientific queries
Name 5077 0
Fiona Brownfoot
Address 5077 0
The Royal Women's Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country 5077 0
Australia
Phone 5077 0
61 3 8345 2000
Fax 5077 0
Email 5077 0
fiona.brownfoot@thewomens.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23172Study protocol   
23173Statistical analysis plan   
23174Clinical study report   

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.