Clinical trial NCT06796829: Nutritional Status of prEgnant Women Following BariatrIc surgEry
Official title: Nutritional Status of Pregnant Women Following Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity and Obesity-related Medical Conditions
Pregnancy
Metabolic Surgery
Keywords: Nutrient status
Nutritional supplementation
Metabolic bariatric surgery
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Maxima Medical Center
name: Gelderse Vallei Hospital
First posted: 2025-01-28
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Nutrient status during pregnancy
timeFrame: 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:
measure: Neonatal birth weight
timeFrame: Directly after delivery/birth
measure: Gestational weight gain
timeFrame: 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:
measure: Use of supplementation
timeFrame: At trimester 1 (week 1-12), trimester 2 (week 13-26), trimester 3 (week 27-42) and at 2 months post-partum.
measure: Surgery characteristics
timeFrame: At estimated date of conception (first day of last menstrual period + 14 days)
measure: Pregnancy outcomes
timeFrame: From the estimated date of conception (first day of last menstrual period + 14 days) until date of delivery
Locations:
city: Elst
country: Netherlands
facility: Rijnstate/Vitalys
state: Gelderland
Study officials:
References:
citation: 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.