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Clinical trial

Effect Of Azithromycin On Pregnancy Prolongation In Women at Risk of Preterm Labour

ID
Name
Azithromycin preterm
Description
The aim of this study is to evaluate the benefit of the addition of azithromycin to standard treatments to prolong pregnancy in women having intact membranes and is at risk of or in preterm labour.
Trial arms
Trial start
2023-07-30
Estimated PCD
2023-09-30
Trial end
2024-05-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
azithromycin
azithromycin.:500 mg PO once for 5 days every month
Arms:
Azithromycin
Other names:
zisrocin
Size
200
Primary endpoint
Gestational age at time of delivery
9 months
Eligibility criteria
Inclusion Criteria: * 24 \< Pregnancy \<37 weeks of gestation. * Threat or history of preterm labour. * Preterm labour itself (Non established) Exclusion Criteria: * antibiotics use within 14 days (except for pericerclage prophylaxis, or streptococcus B prophylaxis); * PPROM; and fetal extraction required \<37 weeks. * Current or past history of medical diseases (Diabetes Milletus, Hypertension, Systemic Lupus Erythematosus, Cardiac diseases, etc ). * Adverse perinatal outcome due to abdominal trauma. * Structural fetal anomalies detected during anomaly scan. * Allergy to Azithromycin.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-08-02

1 organization

1 product

1 indication

Organization
Beni-Suef University
Product
azithromycin
Indication
Preterm Labour