Nutritional Status of prEgnant Women Following BariatrIc surgEry

Completed

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

• Registration Number: NCT06796829
• Lead Sponsor: Rijnstate Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-02
• Primary Completion: 2022-08-12
• Study Completion: 2022-11-03
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nutrient status during pregnancy	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 Outcome Measures

Name	Time	Method
Neonatal birth weight	Directly after delivery/birth	Neonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.
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)	Gestational weight gain in kg and classification of weight gain according to IOM recommendations.

Trial Locations

Locations (1)

Rijnstate/Vitalys; 🇳🇱 Elst, Gelderland, Netherlands