Bariatric SurgeryMOBSNCT07877233
Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
An observational study of Bariatric Surgery and Pregnency, run by Helse Nord-Trøndelag HF at 3 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bariatric Surgery, Pregnency, Reproductive Health and Childbirth
- What is being tested?
- Post-Bariatric Maternal and Infant Health Study and Observation arm
- How many people
- 210 participants
- Where
- 3 sitesNorway
- Study dates
- 25 Dec 2025to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Nord Trøndelag Hospital Trust Namsos and Levanger Hospital St Olavs University Hospital Møre and Romsdal Hospital Trust, Ålesund Hospital
Who may be able to join
- pregnant
- sufficient understanding of the Norwegian or Scandinavian language
- written informed consent
Who cannot join
- multiple gestations,
- pre-pregnancy BMI < 18.5 kg/m2
- insulin treated diabetes mellitus
- termination of pregnancy before 14 weeks (spontaneously or induced)
- anorexia
- bullemia
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Camilla BO Hovland, MSc contact
Norway3 sites, 3 recruiting
- Recruiting
Ålesund Hospital
Ålesund, Møre og Romsdal
Kirsti K Bjerkan, PhD, +47 92400081, Kirsti.Kverndokk.Bjerkan@helse-mr.no
Camilla BO Hovland, MSc, ann.kristin.hjelle.de.soysa@stolav.no
- Recruiting
Namsos Hospital
Namsos, Trøndelag, 7800
Siren Nymo, PhD, 99514188, siren.nymo@hnt.no
Camilla BO Hovland, MSc, camilla.benedicte.ording.hovland@helse-nordtrondelag.no
- Recruiting
St Olavs University Hospital
Trondheim, Trøndelag, 7800
Ann Kristin H de Soysa, PhD, 004772825274, ann.kristin.hjelle.de.soysa@stolav.no
Camilla BO Hovland, MSc, ann.kristin.hjelle.de.soysa@stolav.no
About this study
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.
Read more
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.
- Being tested
- Post-Bariatric Maternal and Infant Health Study, Observation arm
- Keywords
- Nutritional status, Micronutrient deficiency, Gestational weight gain, Maternal anemia, Nutritional supplementation, Perinatal outcomes
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-Bariatric Maternal and Infant Health StudyOther
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.
Observation armOther
Comparing antropometri and Blood sampels between groups
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with a history of Bariatric Surgery | Not described Receives: Other: Post-Bariatric Maternal and Infant Health Study | |
| Pregnant women with no prior history of Bariatric Surgery | Not described Receives: Other: Observation arm | |
| New-borns of women with a history of Bariatric Surgery | Not described Receives: Other: Post-Bariatric Maternal and Infant Health Study | |
| New-borns of women with-out a history of Bariatric Surgery | Not described Receives: Other: Observation arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Iron status
Ferritin (µg/L)
Measured: At four time points: ≤19 weeks of gestation, 24-26 weeks of gestation, 30-34 weeks of gestation, and 6-12 weeks postpartum.
Maternal gestational weight gain following bariatric surgery, compared with non-operated controls.
Changes in maternal weight (kg) at the different timpoints
Measured: 2.th, 3.th trimester and 6 weeks postpartum
Secondary outcomes (3)
Newborn birth weight
Birth weight (g)
Measured: at birth
Birth length
Length (cm)
Measured: at birth
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.
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start25 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University of Copenhagen, Helse Møre og Romsdal Hospital Trust
- Responsible party
- Principal investigator, Siren Nymo, Helse Nord-Trøndelag HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877233
- Sponsor's protocol ID
- 560978
- Acronym
- MOBS
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided