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Completed

NCT Number: NCT06796829

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.

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Body Weight Metabolic Surgery Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rijnstate/Vitalys

Elst, Gelderland, 6662 NC, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neonatal birth weight

    Time frame: Directly after delivery/birth

    Neonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.

  2. 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)

    Gestational weight gain in kg and classification of weight gain according to IOM recommendations.

Other outcomes

  1. Use of supplementation

    Time frame: At 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

  2. Surgery characteristics

    Time frame: At estimated date of conception (first day of last menstrual period + 14 days)

    Type of bariatric procedure and time from surgery to conception

  3. Pregnancy outcomes

    Time frame: From the estimated date of conception (first day of last menstrual period + 14 days) until date of delivery

    Incidence of pregnancy complications including spontaneous abortion, preterm birth, gestational diabetes mellitus, hypertensive disorders, hyperemesis gravidarum, internal herniation, birth defects, NICU admission.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Gelderse Vallei Hospital
  • Maxima Medical Center

Registry information

Acronym: NEWBIE

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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