Trial Review

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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
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
Secondary ID [1] 309185 0
None
Universal Trial Number (UTN)
U1111-1289-6681
Trial acronym
BUMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bariatric surgery 329317 0
Vitamin and mineral deficiency 329318 0
Preterm birth 329319 0
Small neonates 329320 0
Condition category
Condition code
Diet and Nutrition 326262 326262 0 0
Obesity
Diet and Nutrition 326263 326263 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 326264 326264 0 0
Complications of newborn
Reproductive Health and Childbirth 326265 326265 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
18
Target follow-up type
Weeks
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.
Intervention code [1] 325629 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334239 0
Gestational weight gain according to Institute of Medicine recommendations collected from participants using an online survey and verified with the medical record.
Timepoint [1] 334239 0
36-weeks - gestational weight gain will be determined using pre-pregnancy weight and weight at 36 weeks gestation.
Secondary outcome [1] 419959 0
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.
Timepoint [1] 419959 0
<23 weeks gestation, 28 weeks gestation, 36 weeks gestation
Secondary outcome [2] 421554 0
Maternal iron deficiency (haemoglobin <110g/L or 105g/L in second trimester) and iron deficiency anaemia (iron deficiency with Ferritin <30ng/mL).
Timepoint [2] 421554 0
Each trimester as part of routine clinical care.
Secondary outcome [3] 421555 0
Folate deficiency (serum folate <5.4 nmol/L, <0.8 nmol/L or <2.6 nmol/L in each trimester, respectively)
Timepoint [3] 421555 0
Measured each trimester as part of routine care.
Secondary outcome [4] 421556 0
Maternal vitamin A deficiency (serum retinol <1.05 umol/L )
Timepoint [4] 421556 0
Measured each trimester as part of routine care.
Secondary outcome [5] 421557 0
Maternal vitamin B12 deficiency (serum B12 <150 pmol/L)
Timepoint [5] 421557 0
Each trimester as part of routine clinical care.
Secondary outcome [6] 421558 0
Maternal vitamin D deficiency (serum 25-hydroxy vitamin D <50 nmol/L )
Timepoint [6] 421558 0
Each trimester as part of routine clinical care.
Secondary outcome [7] 421559 0
Maternal zinc deficiency (serum zinc <8.5 umol/L in first trimester or <7.8 umol/L in second or third trimester
Timepoint [7] 421559 0
Each trimester as part of routine clinical care.
Secondary outcome [8] 421560 0
Maternal adherence to micronutrient supplementation measured using the Brief Medication Adherence Questionnaire administered via online survey.
Timepoint [8] 421560 0
At enrollment (<23-weeks), 28-weeks and 36-weeks gestation.
Secondary outcome [9] 421561 0
Presence and severity of dumping syndrome measured using the Dumping Syndrome Rating Scale administered using an online survey
Timepoint [9] 421561 0
Enrolment (<23-weeks), 28-weeks and 36-weeks gestation.
Secondary outcome [10] 421562 0
Presence and severity of nausea, vomiting, reflux and constipation throughout pregnancy measured using the gastrointestinal quality of life scale administered using online survey.
Timepoint [10] 421562 0
Enrolment (<23 weeks), 28-weeks and 36-weeks.
Secondary outcome [11] 421563 0
Preterm birth (birth <37-weeks gestation) obtained from medical records.
Timepoint [11] 421563 0
Birth
Secondary outcome [12] 421564 0
SGA offspring measured using routine USS and birth weight (adjusted for gestational age and gender) from medical records.
Timepoint [12] 421564 0
Ultrasound each trimester as part of routine care and birth.

Eligibility
Key inclusion criteria
Less than or equal to 22 weeks gestation
Birthing at a recruiting facility
History of bariatric surgery
English speaking
Consenting
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Proposed sample size n=100.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
100
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24267 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 24268 0
Caboolture Hospital - Caboolture
Recruitment hospital [3] 24269 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [4] 24270 0
Logan Hospital - Meadowbrook
Recruitment hospital [5] 24272 0
Mackay Base Hospital - Mackay
Recruitment hospital [6] 24273 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 39808 0
4020 - Redcliffe
Recruitment postcode(s) [2] 39806 0
4029 - Herston
Recruitment postcode(s) [3] 39812 0
4101 - South Brisbane
Recruitment postcode(s) [4] 39809 0
4131 - Meadowbrook
Recruitment postcode(s) [5] 39807 0
4510 - Caboolture
Recruitment postcode(s) [6] 39811 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 313372 0
Hospital
Name [1] 313372 0
Royal Brisbane Women's Hospital Foundation
Country [1] 313372 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane Women's Hospital
Address
Butterfield St, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 315146 0
University
Name [1] 315146 0
The University of Queensland, Faculty of Medicine
Address [1] 315146 0
Butterfield St, Herston, QLD 4029
Country [1] 315146 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312589 0
Metro North Health HREC B
Ethics committee address [1] 312589 0
The Prince Charles Hospital
627 Rode Rd, Chermside, QLD 4032
Ethics committee country [1] 312589 0
Australia
Date submitted for ethics approval [1] 312589 0
07/09/2021
Approval date [1] 312589 0
19/10/2021
Ethics approval number [1] 312589 0
77266

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125202 0
Ms Taylor Guthrie
Address 125202 0
Royal Brisbane Women's Hospital,
Department of Dietetics and Foodservices,
Level 2, James Maybe Building,
Butterfield St, Herston,
QLD 4029
Country 125202 0
Australia
Phone 125202 0
+61 7 36468268
Fax 125202 0
Email 125202 0
Taylor.Guthrie@health.qld.gov.au
Contact person for public queries
Name 125203 0
Ms Taylor Guthrie
Address 125203 0
Royal Brisbane Women's Hospital,
Department of Dietetics and Foodservices,
Level 2, James Maybe Building,
Butterfield St, Herston,
QLD 4029
Country 125203 0
Australia
Phone 125203 0
+61 7 36468268
Fax 125203 0
Email 125203 0
Taylor.Guthrie@health.qld.gov.au
Contact person for scientific queries
Name 125204 0
Ms Taylor Guthrie
Address 125204 0
Royal Brisbane Women's Hospital,
Department of Dietetics and Foodservices,
Level 2, James Maybe Building,
Butterfield St, Herston,
QLD 4029
Country 125204 0
Australia
Phone 125204 0
+61 7 36468268
Fax 125204 0
Email 125204 0
Taylor.Guthrie@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.