Overview
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.
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.
Eligibility
Inclusion Criteria:
- pregnant
- sufficient understanding of the Norwegian or Scandinavian language
- written informed consent
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
