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RecruitingNCT07877233MOBSUpdated Oct 20, 2026

Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery

An observational study in Bariatric Surgery, Pregnency and Reproductive Health and Childbirth, sponsored by Helse Nord-Trøndelag HF. Recruiting at 3 sites in Norway. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Helse Nord-Trøndelag HF · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Updated Oct 16, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
210
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The goal of this observational study is to learn how bariatric surgery affects the health and nutritional status of women and their babies during pregnancy and after birth. The study will also investigate pregnancy complications and whether the time between surgery and pregnancy affects pregnancy outcomes.

The study includes pregnant women who have undergone bariatric surgery and pregnant women who have not had surgery.

The main questions this study aims to answer are:

  • Are vitamin and mineral deficiencies more common during pregnancy in women who have had bariatric surgery?
  • Are pregnancy complications, such as preterm birth and high blood pressure, more common after bariatric surgery?
  • Do babies born to women who have had bariatric surgery differ in growth and vitamin and mineral levels?

Researchers will compare women with and without previous bariatric surgery to look for differences in:

  • Vitamin and mineral levels in blood and urine
  • Pregnancy complications, including gestational diabetes and preeclampsia
  • Babies' birth weight, length, and vitamin and mineral levels

Participants will:

  • Provide blood and urine samples during pregnancy and after birth
  • Answer questions about their diet, health, and lifestyle
  • Have their weight and body composition measured
  • Wear a device that measures blood sugar levels for approximately two weeks during pregnancy

The findings may help improve nutritional care and pregnancy follow-up for women who have undergone bariatric surgery.

Read the detailed description

The Maternal Outcomes after Bariatric Surgery (MOBS) study is a prospective, multicenter observational cohort study investigating maternal nutritional status, glucose regulation, gestational weight gain, pregnancy complications, and neonatal outcomes following bariatric surgery.

The study aims to include 210 pregnant women, comprising 70 women with previous bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) and 140 pregnant women without previous bariatric surgery who had a prepregnancy body mass index (BMI) ≥25 kg/m².

Participants are recruited before gestational week 19 and followed throughout pregnancy and up to 12 weeks postpartum. Data are collected at several study visits during pregnancy and after delivery.

Maternal assessments include dietary intake, nutritional supplement use, anthropometric measurements, body composition assessed by bioelectrical impedance analysis (BIA), blood pressure, and biochemical markers of nutritional status. Dietary intake is assessed using food frequency questionnaires and 24-hour dietary recalls. Blood and urine samples are collected to assess vitamin and mineral status and other relevant biochemical parameters.

Continuous glucose monitoring (CGM) is performed for approximately 15 days during mid-pregnancy to assess glucose patterns, glycemic variability, and episodes of hypoglycemia.

Information on maternal health, pregnancy complications, gestational diabetes, hypertensive disorders of pregnancy, and delivery outcomes is obtained from questionnaires and medical records.

Neonatal assessments include birth weight, length, and biochemical markers of nutritional status measured in samples collected at birth.

The study will compare maternal and neonatal outcomes between women with and without previous bariatric surgery. Associations between nutritional status, dietary intake, glucose regulation, gestational weight gain, and pregnancy outcomes will also be investigated. Among women with previous bariatric surgery, the potential association between time since surgery and pregnancy outcomes will be explored.

The findings are expected to contribute to improved nutritional monitoring and clinical follow-up of women during pregnancy after bariatric surgery.

02

Conditions studied

  • Bariatric Surgery
  • Pregnency
  • Reproductive Health and Childbirth
  • Pregnancy and Delivery

Keywords

  • Nutritional status
  • Micronutrient deficiency
  • Gestational weight gain
  • Maternal anemia
  • Nutritional supplementation
  • Perinatal outcomes
03

In context

Gestational Weight Gain

123 studies on the registry are indexed under Gestational Weight Gain; 20 are open to participants now.

This study's planned enrollment of 210 is below the median of 400 across 16 observational studies indexed under Gestational Weight Gain.

Browse Gestational Weight Gain studies →

Lead sponsor

Helse Nord-Trøndelag HF is the lead sponsor of 26 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Nord Trøndelag Hospital Trust Namsos and Levanger Hospital St Olavs University Hospital Møre and Romsdal Hospital Trust, Ålesund Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant
  • sufficient understanding of the Norwegian or Scandinavian language
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • multiple gestations,
  • pre-pregnancy BMI \< 18.5 kg/m2
  • insulin treated diabetes mellitus
  • termination of pregnancy before 14 weeks (spontaneously or induced)
  • anorexia
  • bullemia
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
210 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pregnant women with a history of Bariatric Surgery

    Other: Post-Bariatric Maternal and Infant Health Study

  • Pregnant women with no prior history of Bariatric Surgery

    Other: Observation arm

  • New-borns of women with a history of Bariatric Surgery

    Other: Post-Bariatric Maternal and Infant Health Study

  • New-borns of women with-out a history of Bariatric Surgery

    Other: Observation arm

Interventions

  • OtherPost-Bariatric Maternal and Infant Health Study

    Comprehensive Nutritional and Pregnancy Monitoring in Women Following Bariatric Surgery This intervention involves systematic monitoring of nutritional status, gestational weight gain, and pregnancy outcomes in women who have undergone bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy). It includes blood and urine sampling, dietary assessments, body composition analysis, and continuous glucose monitoring throughout pregnancy and postpartum. The study also includes matched control groups of non-operated pregnant women and their newborns.

  • OtherObservation arm

    Comparing antropometri and Blood sampels between groups

06

What researchers measure

Primary outcomes

  1. Maternal Iron status

    Ferritin (µg/L)

    Time frame: At four time points: ≤19 weeks of gestation, 24-26 weeks of gestation, 30-34 weeks of gestation, and 6-12 weeks postpartum.

  2. Maternal gestational weight gain following bariatric surgery, compared with non-operated controls.

    Changes in maternal weight (kg) at the different timpoints

    Time frame: 2.th, 3.th trimester and 6 weeks postpartum

Secondary outcomes

  1. Newborn birth weight

    Birth weight (g)

    Time frame: at birth

  2. Birth length

    Length (cm)

    Time frame: at birth

  3. Vitamin B12 concentration in neonatal cord blood

    Vitamin B12 concentration (pmol/L) in cord blood from newborns of mothers with previous bariatric surgery compared with newborns of mothers without previous bariatric surgery.

    Time frame: at birth

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 2 updates
  1. Oct 20, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07877233
Lead sponsor
Helse Nord-Trøndelag HF
Collaborators
St. Olavs Hospital, University of Copenhagen, Helse Møre og Romsdal Hospital Trust
Responsible party
Siren Nymo (Associated Professor, Helse Nord-Trøndelag HF) — Principal investigator
First posted
Oct 16, 2026
Start date
Dec 25, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Siren Nymo, PhD
Contact
siren.nymo@hnt.no
+4799514188

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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