Hypoglycemia in post-bariatric vs. non-bariatric pregnancy: incidence and effects on fetal growth

Conditions: hypoglycemia
low blood sugar
10018424
10016849
10017998

Registration Number: NL-OMON56907

Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 174

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria: Pregnant, either after metabolic-bariatric surgery
(Roux-en-Y gastric bypass or One anastomosis gastric bypass performed at CON,
MCL with pre-surgery BMI >40, and post-BS total weight loss (TWL) of >20%), or
without metabolic-bariatric surgery with BMI >40 or BMI between 18.5-24.9. At
the time of inclusion, the subject must be between 6-10 weeks pregnant.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Diagnosis with type 1 or type 2 diabetes before the pregnancy, or diagnosis
with type 1 or type 2 diabetes or GDM before the BS.
- Diagnosis with severe psychiatric or medical comorbidities known to
potentially affect fetal growth (e.g. severe depression, lupus, chronic kidney
disease).
- Continued smoking, alcohol consumption, or substance use throughout the
pregnancy.
- Allergy for plasters.
- Multiple pregnancy.
- Pregnancy less than 12 months after bariatric surgery.
- Post-bariatric total weight loss of <20%

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the number of hypoglycemic events (fasting and<br /><br>postprandial) during post-bariatric pregnancies and non-bariatric pregnancies<br /><br>(with obese and healthy BMI). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are neonatal birthweight, gestational weight<br /><br>gain, placental weight and histology, micronutrient deficiency, and nu number<br /><br>of hyperglycemic events. Other parameters are data from the patient file (age,<br /><br>ethnicity, comorbidities, pre-bariatric weight). </p><br>