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Trial registered on ANZCTR
Registration number
ACTRN12623000495628
Ethics application status
Approved
Date submitted
12/03/2023
Date registered
15/05/2023
Date last updated
15/05/2023
Date data sharing statement initially provided
15/05/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Bariatric sUrgery and Maternal nutrition in Pregnancy (BUMP) Study
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Scientific title
The Bariatric sUrgery and Maternal nutrition in Pregnancy Study: A prospective cohort study investigating the impact of bariatric surgery prior to pregnancy on nutrition status, maternal and offspring outcomes
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Secondary ID [1]
309185
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None
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Universal Trial Number (UTN)
U1111-1289-6681
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Trial acronym
BUMP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bariatric surgery
329317
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Vitamin and mineral deficiency
329318
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Preterm birth
329319
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Small neonates
329320
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Condition category
Condition code
Diet and Nutrition
326262
326262
0
0
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Obesity
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Diet and Nutrition
326263
326263
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0
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Other diet and nutrition disorders
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Reproductive Health and Childbirth
326264
326264
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0
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Complications of newborn
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Reproductive Health and Childbirth
326265
326265
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0
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
18
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Target follow-up type
Weeks
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Description of intervention(s) / exposure
Women in The BUMP Study complete online questionnaires at enrolment (<22 weeks gestation), 28-weeks and 36-weeks gestation. Each questionnaire takes about 10 minutes to complete and collects data about:
Gestational weight gain
Micronutrient supplementation and adherence
Demographics (first survey only)
Presence and severity of nutrition impact symptoms (nausea, vomiting, dumping syndrome, reflux, bowel dysfunction)
Women will also complete 3x non-consecutive 24 hour recalls at each time point.
Other data is collected from routine care from the medical record after birth.
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Intervention code [1]
325629
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Diagnosis / Prognosis
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Gestational weight gain according to Institute of Medicine recommendations collected from participants using an online survey and verified with the medical record.
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Assessment method [1]
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Timepoint [1]
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36-weeks - gestational weight gain will be determined using pre-pregnancy weight and weight at 36 weeks gestation.
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Secondary outcome [1]
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Adherence to Australian dietary guidelines measured using 3x non-consecutive 24-hour recalls collected at three different timepoints in pregnancy. Dietary intake will be recorded using an online multiple pass method via the ASA24-Australia.
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Assessment method [1]
419959
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Timepoint [1]
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<23 weeks gestation, 28 weeks gestation, 36 weeks gestation
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Secondary outcome [2]
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Maternal iron deficiency (haemoglobin <110g/L or 105g/L in second trimester) and iron deficiency anaemia (iron deficiency with Ferritin <30ng/mL).
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Assessment method [2]
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Timepoint [2]
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Each trimester as part of routine clinical care.
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Secondary outcome [3]
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Folate deficiency (serum folate <5.4 nmol/L, <0.8 nmol/L or <2.6 nmol/L in each trimester, respectively)
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Assessment method [3]
421555
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Timepoint [3]
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Measured each trimester as part of routine care.
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Secondary outcome [4]
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Maternal vitamin A deficiency (serum retinol <1.05 umol/L )
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Assessment method [4]
421556
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Timepoint [4]
421556
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Measured each trimester as part of routine care.
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Secondary outcome [5]
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Maternal vitamin B12 deficiency (serum B12 <150 pmol/L)
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Assessment method [5]
421557
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Timepoint [5]
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Each trimester as part of routine clinical care.
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Secondary outcome [6]
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Maternal vitamin D deficiency (serum 25-hydroxy vitamin D <50 nmol/L )
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Assessment method [6]
421558
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Timepoint [6]
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Each trimester as part of routine clinical care.
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Secondary outcome [7]
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Maternal zinc deficiency (serum zinc <8.5 umol/L in first trimester or <7.8 umol/L in second or third trimester
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Assessment method [7]
421559
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Timepoint [7]
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Each trimester as part of routine clinical care.
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Secondary outcome [8]
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Maternal adherence to micronutrient supplementation measured using the Brief Medication Adherence Questionnaire administered via online survey.
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Assessment method [8]
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Timepoint [8]
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At enrollment (<23-weeks), 28-weeks and 36-weeks gestation.
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Secondary outcome [9]
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Presence and severity of dumping syndrome measured using the Dumping Syndrome Rating Scale administered using an online survey
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Assessment method [9]
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Timepoint [9]
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Enrolment (<23-weeks), 28-weeks and 36-weeks gestation.
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Secondary outcome [10]
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Presence and severity of nausea, vomiting, reflux and constipation throughout pregnancy measured using the gastrointestinal quality of life scale administered using online survey.
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Assessment method [10]
421562
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Timepoint [10]
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Enrolment (<23 weeks), 28-weeks and 36-weeks.
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Secondary outcome [11]
421563
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Preterm birth (birth <37-weeks gestation) obtained from medical records.
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Assessment method [11]
421563
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Timepoint [11]
421563
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Birth
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Secondary outcome [12]
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SGA offspring measured using routine USS and birth weight (adjusted for gestational age and gender) from medical records.
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Assessment method [12]
421564
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Timepoint [12]
421564
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Ultrasound each trimester as part of routine care and birth.
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Eligibility
Key inclusion criteria
Less than or equal to 22 weeks gestation
Birthing at a recruiting facility
History of bariatric surgery
English speaking
Consenting
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Twin or triplet pregnancies
Conditions that may impact micronutrient metabolism other than bariatric surgery (such as cystic fibrosis, chronic kidney disease, inflammatory bowel disease).
Non-english speaking or otherwise unable to provide verbal and written consent
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Proposed sample size n=100.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/06/2022
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Date of last participant enrolment
Anticipated
30/06/2024
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
100
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Accrual to date
35
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
24267
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [2]
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Caboolture Hospital - Caboolture
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Recruitment hospital [3]
24269
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Redcliffe Hospital - Redcliffe
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Recruitment hospital [4]
24270
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Logan Hospital - Meadowbrook
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Recruitment hospital [5]
24272
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Mackay Base Hospital - Mackay
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Recruitment hospital [6]
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Mater Mother's Hospital - South Brisbane
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Recruitment postcode(s) [1]
39806
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4029 - Herston
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Recruitment postcode(s) [2]
39807
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4510 - Caboolture
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Recruitment postcode(s) [3]
39808
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4020 - Redcliffe
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Recruitment postcode(s) [4]
39809
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4131 - Meadowbrook
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Recruitment postcode(s) [5]
39811
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4740 - Mackay
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Recruitment postcode(s) [6]
39812
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
313372
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Hospital
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Name [1]
313372
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Royal Brisbane Women's Hospital Foundation
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Address [1]
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Butterfield St, Herston, QLD, 4029
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Country [1]
313372
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Australia
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Primary sponsor type
Hospital
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Name
Royal Brisbane Women's Hospital
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Address
Butterfield St, Herston, QLD, 4029
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Country
Australia
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Secondary sponsor category [1]
315146
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University
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Name [1]
315146
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The University of Queensland, Faculty of Medicine
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Address [1]
315146
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Butterfield St, Herston, QLD 4029
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Country [1]
315146
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312589
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Metro North Health HREC B
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Ethics committee address [1]
312589
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The Prince Charles Hospital
627 Rode Rd, Chermside, QLD 4032
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Ethics committee country [1]
312589
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Australia
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Date submitted for ethics approval [1]
312589
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07/09/2021
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Approval date [1]
312589
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19/10/2021
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Ethics approval number [1]
312589
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77266
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Summary
Brief summary
Aim: The overall aim of this research is to report on maternal weight status prior to pregnancy and nutrition status (weight gain, oral intake, micronutrient deficiencies) during pregnancy after bariatric surgery and its association with maternal and offspring outcomes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Taylor Guthrie
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Address
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Royal Brisbane Women's Hospital,
Department of Dietetics and Foodservices,
Level 2, James Maybe Building,
Butterfield St, Herston,
QLD 4029
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Country
125202
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Australia
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Phone
125202
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+61 7 36468268
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Fax
125202
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Email
125202
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[email protected]
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Contact person for public queries
Name
125203
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Ms Taylor Guthrie
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Address
125203
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Royal Brisbane Women's Hospital,
Department of Dietetics and Foodservices,
Level 2, James Maybe Building,
Butterfield St, Herston,
QLD 4029
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Country
125203
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Australia
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Phone
125203
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+61 7 36468268
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Fax
125203
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Email
125203
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[email protected]
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Contact person for scientific queries
Name
125204
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Ms Taylor Guthrie
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Address
125204
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Royal Brisbane Women's Hospital,
Department of Dietetics and Foodservices,
Level 2, James Maybe Building,
Butterfield St, Herston,
QLD 4029
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Country
125204
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Australia
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Phone
125204
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+61 7 36468268
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Fax
125204
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Email
125204
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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