Status:
COMPLETED
Antenatal Azithromycin to Prevent Preterm Birth in Pregnant Women With Vaginal Cerclage
Lead Sponsor:
Ain Shams Maternity Hospital
Conditions:
Preterm Birth
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief Summary
In women with indicated vaginal cerclage, this study aims to assess the efficacy of antenatal prophylactic Azithromycin in preventing preterm labor.
Detailed Description
Study procedures and interventions: 1. After approval of study protocol, pregnant women who underwent vaginal cerclage at Ain Shams University Maternity Hospital will be enrolled into the study accor...
Eligibility Criteria
Inclusion
- Gestational age (14-34 weeks).
- Pregnant women who underwent vaginal cerclage (either history- based or ultrasound based vaginal cerclage)
- History based cerclage:
- History of one or more second-trimester pregnancy losses related to painless cervical dilatation and in absence of labor or abruptio placentae; OR
- Prior cerclage due to painless cervical dilation in the second trimester
- Ultrasound based cerclage:
- Current singleton pregnancy, prior spontaneous preterm birth at less than 34 weeks of gestation, and short cervical length (less than 25 mm) before 24 weeks of gestation
Exclusion
- Multiple pregnancy.
- 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
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04278937
Start Date
April 15 2019
End Date
April 15 2020
Last Update
June 16 2020
Active Locations (1)
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1
Ain Shams Maternity Hospital
Cairo, Egypt