Status:
COMPLETED
Gestational Treatment With Ursodeoxycholic Acid Compared to Placebo to Reduce Severity of Gestational Diabetes Mellitus Diagnosed at 24-28 Weeks' Gestation
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The trial will compare the influence of treatment with ursodeoxycholic acid (UDCA) compared to placebo on glycaemic control (primary outcome) in women with GDM after a positive diagnosis at 24-28 week...
Eligibility Criteria
Inclusion
- Women with GDM diagnosed at 24-28 weeks' gestation in accordance with Spanish guidelines in accordance with NDDG criteria, i.e. two or more glucose concentrations (fasting: ≥ 5.8 mmol/L (105 mg/dL), 1 h: ≥10.6 mmol/L, (190 mg/dL) 2 h: ≥9.2 mmol/L (165 mg/dL), 3 h: ≥ 8.1 mmol/L (145 mg/dL)) after a standard 100g OGTT, two fasting blood glucose levels ≥ 126 mg/dl, on different days, or at random ≥ 200 mg/dL or a plasma glucose value greater than 200 mg/dL after OSullivan test
- Planned antenatal care at the same centre (i.e. not planning to move before delivery).
- Singleton pregnancy.
- Informed and written consent.
Exclusion
- Age \<18 years;
- Multiple pregnancy in current pregnancy;
- Unconscious or very ill;
- Serious mental illness;
- Learning difficulties;
- Not fluent in local language and absence of interpreter.
- Severe congenital anomaly on ultrasound
- Previous diagnosis of diabetes outside of pregnancy
- Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (\<1 year)
- Significant co-morbidity in the current pregnancy, nephropathy (estimated GF\<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results
- Participating in another intervention study that will influence the outcome of this trial (to be advised by CI or PI).
- Known allergy/hypersensitivity/intolerance to the active substance or excipients.
- Hypersensitivity to Ursodexosolic acid or to the following excipients: Magnesium stearate, cellulose powder, colloidal silica and sodium carboxymethyl starch, gelatin, titanium dioxide, quinoline yellow, orange yellow S, indigotine.
- Patients with a non-functioning gallbladder, in patients with calcified cholesterol stones, radio-opaque stones, radiolucent gallbladder stones.
- Gastric or duodenal ulcer.
- Liver or intestinal disorders that interfere with the enterohepatic circulation: acute cholecystitis that does not subside, cholangitis, biliary obstruction, pancreatitis due to stones, patients with gastrointestinal-biliary fistula.
- Breastfeeding
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2022
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT06127355
Start Date
March 3 2021
End Date
May 10 2022
Last Update
November 14 2023
Active Locations (1)
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1
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120