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Nutritional Status of prEgnant Women Following BariatrIc surgEry

Nutritional Status of Pregnant Women Following Bariatric Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06796829
Acronym
NEWBIE
Enrollment
129
Registered
2025-01-28
Start date
2018-11-02
Completion date
2022-11-03
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Surgery, Obesity and Obesity-related Medical Conditions, Pregnancy

Keywords

Nutrient status, Nutritional supplementation, Metabolic bariatric surgery

Brief 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.

Interventions

None listed

Sponsors

Maxima Medical Center
CollaboratorOTHER
Gelderse Vallei Hospital
CollaboratorOTHER
Rijnstate Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Nutrient status during pregnancyNutrient 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.

Secondary

MeasureTime frameDescription
Neonatal birth weightDirectly after delivery/birthNeonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.
Gestational weight gainFrom the beginning of pregnancy (max 3 months before conception until 1 month after conception) until date of delivery (max 2 weeks before event)Gestational weight gain in kg and classification of weight gain according to IOM recommendations.

Other

MeasureTime frameDescription
Use of supplementationAt trimester 1 (week 1-12), trimester 2 (week 13-26), trimester 3 (week 27-42) and at 2 months post-partum.Self-reported use of (multivitamin) supplementation
Surgery characteristicsAt estimated date of conception (first day of last menstrual period + 14 days)Type of bariatric procedure and time from surgery to conception
Pregnancy outcomesFrom the estimated date of conception (first day of last menstrual period + 14 days) until date of deliveryIncidence of pregnancy complications including spontaneous abortion, preterm birth, gestational diabetes mellitus, hypertensive disorders, hyperemesis gravidarum, internal herniation, birth defects, NICU admission.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026