Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial

ID
Name
681/2023
Description
This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.
Trial arms
Trial start
2023-08-16
Estimated PCD
2025-08-31
Trial end
2025-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Micronized progesterone
Vaginal micronized progesterone effervescent once daily until delivery
Arms:
Micronized progesterone
Size
48
Primary endpoint
latency period
13 weeks
Eligibility criteria
Inclusion Criteria: * singleton pregnancy with gestational age 24-33 weeks 6 days * preterm labor * received treatment with tocolysis and corticosteroids Exclusion Criteria: * conditions that need immediate delivery such as fetal distress, chorioamnionitis * have medical complications such as heart disease, seizure * fetal anomalies * cervical dilatation more than 5 cm * allergy to progesterone * contraindication to progesterone * contraindication to tocolytic use
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2023-08-30

1 organization

1 product

1 indication

Organization
Chulalongkorn University
Product
Micronized progesterone
Indication
Preterm Labour