Nutritional Status of prEgnant Women Following BariatrIc surgEry

NCT06796829 | Completed

• 1 other identifier: 2018-1267
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Nutrient status; Nutritional supplementation; Metabolic bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Directly after delivery/birth

• Gestational weight gain

  From the beginning of pregnancy (max 3 months before conception until 1 month after conception) until date of delivery (max 2 weeks before event)

Other Outcomes (3)

• Use of supplementation

  At trimester 1 (week 1-12), trimester 2 (week 13-26), trimester 3 (week 27-42) and at 2 months post-partum.

• Surgery characteristics

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

• Pregnancy outcomes

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study on pregnancy. Therefore limited to female sex at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Maxima Medical Center: collaborator
• Gelderse Vallei Hospital: collaborator

Study Sites (1)

Rijnstate/Vitalys

Elst, Gelderland, 6662 NC, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39141187 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 28, 2025
• Study Start: November 2, 2018
• Primary Completion: August 12, 2022
• Study Completion: November 3, 2022
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)