Nutritional Status of prEgnant Women Following BariatrIc surgEry

NCT ID: NCT06796829

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-02

Study Completion Date

2022-11-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity and Obesity-related Medical Conditions Pregnancy Metabolic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Older than 18 years
* Medical history of metabolic bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy)

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maxima Medical Center

OTHER

Sponsor Role collaborator

Gelderse Vallei Hospital

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rijnstate/Vitalys

Elst, Gelderland, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 39141187 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-1267

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Bariatric Surgery
NCT02857179 RECRUITING