| Trial ID: | L4858 |
| Source ID: | NCT06127355
|
| Associated Drug: |
500 Mg Of Ursodeoxycholic Acid (Udca)
|
| Title: |
Gestational Treatment With Ursodeoxycholic Acid Compared to Placebo to Reduce Severity of Gestational Diabetes Mellitus Diagnosed at 24-28 Weeks' Gestation
|
| Acronym: |
GUARDS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Gestational Diabetes
|
| Interventions: |
DRUG: 500 mg of ursodeoxycholic acid (UDCA)|OTHER: 500 mg of Placebo
|
| Outcome Measures: |
Primary: Maternal fasting glucose concentration at 36 weeks, aiming to maintain all capillary glucose levels between 3.9-7.8mmol/l (70 - 140 mg/dL). The specific pre- and post-meal self-monitored blood glucose (SMBG) targets are ≤5.3mmol/L before breakfast (95 mg/dL), ≤7.8mmol/L 1-hr post meal (140 mg/dL) and ≤6.7mmol/L (120 mg/dL) 2-hr post meal., Up to 36 weeks | Secondary: Proportion of women requiring insulin treatment, Number of women with insuline treatment, Up to 36 weeks|Proportion of delivery type, Mode of delivery (rates of primary \& repeat CS, elective \& emergency, Up to 40 weeks|Gestational age at delivery, frequency of preterm delivery, Age of patient, Up to 40 weeks|Infant birth weight, Weight in kg, Up to 40 weeks
|
| Sponsor/Collaborators: |
Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
113
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-03-03
|
| Completion Date: |
2022-05-10
|
| Results First Posted: |
|
| Last Update Posted: |
2023-11-14
|
| Locations: |
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, 30120, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT06127355
|
