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Gestational Treatment With Ursodeoxycholic Acid Compared to Placebo to Reduce Severity of Gestational Diabetes Mellitus Diagnosed at 24-28 Weeks' Gestation

NCT06127355 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2023-11-14

No results posted yet for this study

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 weeks of gestation.

The investigators will evaluate maternal and fetal lipid and glucose metabolism. Neonatal health outcomes will also be studied, including the rate of LGA. UDCA is used to treat the commonest liver disease of pregnancy, intrahepatic cholestasis of pregnancy (ICP), and has good safety data to support its use in pregnancy 52-57 ., it means, no studies reported any increase in adverse outcomes associated with UDCA treatment. It is noteworthy that in the largest study 52, 8 serious adverse events were reported, 6 of which were in the placebo group, and none were considered to be related to the trial intervention. There were 72 adverse events: 31 in the ursodeoxycholic acid group and 41 in the placebo group. The same number of patients in each group (n=10) reported adverse events related to gastrointestinal disorders.

Conditions

  • Gestational Diabetes

Interventions

DRUG

500 mg of ursodeoxycholic acid (UDCA)

Administration of 500 mg of ursodeoxycholic acid (UDCA) /day

OTHER

500 mg of Placebo

Administration of 500 mg of placebo /day

Sponsors & Collaborators

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2022-02-09
Completion
2022-05-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127355 on ClinicalTrials.gov