Clinical trial

Gestational Diabetes After Gastric Bypass Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT06291766

Recruiting nowNot applicableInterventional

What this study is about

The goal of this trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery. The main question it aims to answer is: How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women. Participants will be randomized to either continous glucose monitoring or regular capillary glucose measurements during the last trimester of their pregnancy. Researchers will compare the glucose measurement outcomes, the glucose lowering treatment given and pregnancy outcomes between groups.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years

SexFemale

Healthy volunteersNot accepted

ConditionDiabetes, Gestational, Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium, Pregnancy in Diabetic, Blood Glucose Self Monitoring

Full registry criteria

Inclusion Criteria: * Understands written and spoken Swedish * Previous Gastric Bypass surgery * Diagnosed with gestational diabetes according to our local criteria * Planned follow up at the Specialized Maternity Ward at Skane University Hospital * Understands the use of CGM and is willing to use the system * Have signed informed consent Exclusion Criteria: * Other kinds of bariatric surgery

Treatments and study arms

FreeStyle Libre 2, continous glucose monitoring

Device

The use of FreeStyle Libre 3 sensors and Libre Link app and Glooko app for analysing glucose control in pregnancy

Primary outcomes

Adverse Pregnancy OutcomeDuring delivery and postpartum (measured up to 5 days postpartum)

ANY: Caesarian section (Y/N), instrumental delivery (Y/N), preeclampsia (Y/N), premature birth before week 37 (Y/N), Macrosomia (\>4000g) (Y/N), Large for gestational age infant (Y/N), small for gestational age infant (Y/N), shoulder dystocia (Y/N), neonatal hypoglycemia (Y/N) (\<4 hours after birth: \<1.4 mmol/L; 4 to \<24 hours after birth: \<1.9 mmol/L; 24 to \<48 hours after birth: \<2.8 mmol/L, ≥48 hours after birth: 3.3 mmol/L

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Region Skane🇸🇪 Lund, Sweden

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Ulrika Moll, MD, PhDContact