Obesity and Obesity-related Medical ConditionsNEWBIENCT06796829
Nutritional Status of prEgnant Women Following BariatrIc surgEry
An observational study of Obesity and Obesity-related Medical Conditions and Pregnancy, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The aim of this observational study is to learn more about nutrient status during pregnancy after bariatric surgery. All pregnant women older than 18 years who underwent bariatric surgery and sought obstetric care within one of the participating hospitals were included and followed up until 2 months post-partum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Pregnancy, Metabolic Surgery
- How many people
- 129 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Nov 2018to 3 Nov 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All pregnant women older than 18 years with a medical history of metabolic bariatric surgery presenting at the obesity or antenatal clinic at one of the participating centers were eligible for recruitment. Participants were preferably included before 12 weeks of pregnancy and followed up until 2 months post-partum.
Who may be able to join
- Older than 18 years
- Medical history of metabolic bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy)
Who cannot join
- Elective termination of pregnancy
- Multiple pregnancy
- Metabolic bariatric procedures other than Roux-en-Y gastric bypass or sleeve gastrectomy
- Reversal of the bariatric procedure
- Malnutrition due to other causes (e.g., malignancy, alcoholism)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Status of Pregnant Women Following Bariatric Surgery
The aim of this observational study is to learn more about nutrient status during pregnancy after bariatric surgery. All pregnant women older than 18 years who underwent bariatric surgery and sought obstetric care within one of the participating hospitals were included and followed up until 2 months post-partum.
- Keywords
- Nutrient status, Nutritional supplementation, Metabolic bariatric surgery
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient status during pregnancy
Nutrient deficiencies during each trimester of pregnancy. Nutrients of primary interest include ferritin, folic acid, vitamin A-D-B12 and albumin.
Measured: Nutrient status was preferably assessed at 4 occasions: During trimester 1 (week 1-12), trimester 2 (week 13-26), trimester 3 (week 27-42) and at 2 months post-partum.
Secondary outcomes (2)
Neonatal birth weight
Neonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.
Measured: Directly after delivery/birth
Gestational weight gain
Gestational weight gain in kg and classification of weight gain according to IOM recommendations.
Measured: From the beginning of pregnancy (max 3 months before conception until 1 month after conception) until date of delivery (max 2 weeks before event)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start2 Nov 2018
- Primary completion12 Aug 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maxima Medical Center, Gelderse Vallei Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796829
- Sponsor's protocol ID
- 2018-1267
- Acronym
- NEWBIE
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heusschen L, Berendsen AAM, van Bon AC, van Laar JOEH, Krabbendam I, Hazebroek EJ. Nutrient Status and Supplement Use During Pregnancy Following Metabolic Bariatric Surgery: A Multicenter Observational Cohort Study. Obes Surg. 2024 Oct;34(10):3608-3618. doi: 10.1007/s11695-024-07446-4. Epub 2024 Aug 14.
PubMed 39141187
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status of Pregnant Women Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06796829
- Acronym / sponsor ID
- NEWBIE / 2018-1267
- Keywords
- Nutrient status, Nutritional supplementation, Metabolic bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Maxima Medical Center, Gelderse Vallei Hospital
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to learn more about nutrient status during pregnancy after bariatric surgery. All pregnant women older than 18 years who underwent bariatric surgery and sought obstetric care within one of the participating hospitals were included and followed up until 2 months post-partum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women older than 18 years with a medical history of metabolic bariatric surgery presenting at the obesity or antenatal clinic at one of the participating centers were eligible for recruitment. Participants were preferably included before 12 weeks of pregnancy and followed up until 2 months post-partum.
Key inclusion criteria (2 listed)
- Older than 18 years
- Medical history of metabolic bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy)
Key exclusion criteria (5 listed)
- Elective termination of pregnancy
- Multiple pregnancy
- Metabolic bariatric procedures other than Roux-en-Y gastric bypass or sleeve gastrectomy
- Reversal of the bariatric procedure
- Malnutrition due to other causes (e.g., malignancy, alcoholism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutrient status during pregnancy
Time frame: Nutrient status was preferably assessed at 4 occasions: During trimester 1 (week 1-12), trimester 2 (week 13-26), trimester 3 (week 27-42) and at 2 months post-partum.
Nutrient deficiencies during each trimester of pregnancy. Nutrients of primary interest include ferritin, folic acid, vitamin A-D-B12 and albumin.
2 secondary outcomes
Neonatal birth weight
Time frame: Directly after delivery/birth
Gestational weight gain
Time frame: From the beginning of pregnancy (max 3 months before conception until 1 month after conception) until date of delivery (max 2 weeks before event)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Results publication: PubMed 39141187Heusschen L, Berendsen AAM, van Bon AC, van Laar JOEH, Krabbendam I, Hazebroek EJ. Nutrient Status and Supplement Use During Pregnancy Following Metabolic Bariatric Surgery: A Multicenter Observational Cohort Study. Obes Surg. 2024 Oct;34(10):3608-3618. doi: 10.1007/s11695-024-07446-4. Epub 2024 Aug 14.
- Individual participant dataSharing planned: No
Related trials for Obesity and Obesity-related Medical Conditions
Recruiting
Transition to Ambulatory Bariatric Surgery (TABS) Trial
Obesity and Obesity-related Medical Conditions, Bariatric Surgery
Active, not recruitingEarly Phase 1
Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
Obesity and Obesity-related Medical Conditions
Recruiting
A Wearable Device and AI-Supported Diet and Exercise Intervention
Obesity and Obesity-related Medical Conditions
Recruiting
Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF)
Appetite, Obesity and Obesity-related Medical Conditions
Active, not recruitingPhase 4
Bariatric Surgery vs. Semaglutide vs. Tirzepatide
Obesity and Obesity-related Medical Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity-related Medical Conditions and Pregnancy, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrient status during pregnancy (time frame: Nutrient status was preferably assessed at 4 occasions: During trimester 1 (week 1-12), trimester 2 (week 13-26), trimester 3 (week 27-42) and at 2 months post-partum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06796829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.