Azithromycin for Preterm Pre-labor Rupture of Membranes
Primary Purpose
Preterm Pre-labor Rupture of Membranes
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Azithromycin
Ampicillin
Azithromycin
Azithromycin
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Pre-labor Rupture of Membranes
Eligibility Criteria
Inclusion Criteria:
- Gestational age is between 28 wks and 37wks
- Singleton living pregnancy.
- Confirmed Premature Pre-labor rupture of membranes (PPROM).
Exclusion Criteria:
- previable rupture of membranes (<23+6wks)
- Multiple gestations
- Macrolide allergy
- patient receiving combination macrolide therapy
- lethal fetal anomalies
- contraindications to expectant management of PPROM at time of diagnosis e.g. concurrent preterm labor, placental abruption, chorioamnionitis or non-reassuring fetal testing
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Azithromycin 1 day group
Azithromycin 5 days group
Arm Description
Patients will receive Azithromycin 1000mg once orally
Patients will receive Azithromycin 500mg once orally, followed by Azithromycin 250mg orally daily for 4 days
Outcomes
Primary Outcome Measures
Days from diagnosis of preterm pre-labor rupture of membranes to delivery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04202380
Brief Title
Azithromycin for Preterm Pre-labor Rupture of Membranes
Official Title
Different Azithromycin Protocols for Management of Preterm Pre-labor Rupture of Membranes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The preterm prelabour rupture of membranes is defined as the spontaneous rupture of the fetal membranes before 37 completed weeks. Preterm prelabour rupture of membranes complicates up to 3% of pregnancies and is associated with 30-40% of preterm births. preterm prelabour rupture of membranes can result in significant neonatal morbidity and mortality, primarily from prematurity, sepsis, cord prolapse, and pulmonary hypoplasia. In addition, there are risks associated with chorioamnionitis and placental abruption The diagnosis of spontaneous rupture of the membranes is made by maternal history followed by a sterile speculum examination. If on speculum examination, no amniotic fluid is observed, clinicians should consider performing an insulin-like growth factor-binding protein-1 or placental alpha microglobulin-1 test of vaginal fluid to guide further management.
One of the risks associated with preterm prelabour rupture of membranes is ascending infection leading to chorioamnionitis, and subsequent fetal and neonatal infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Pre-labor Rupture of Membranes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin 1 day group
Arm Type
Other
Arm Description
Patients will receive Azithromycin 1000mg once orally
Arm Title
Azithromycin 5 days group
Arm Type
Other
Arm Description
Patients will receive Azithromycin 500mg once orally, followed by Azithromycin 250mg orally daily for 4 days
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Patients will receive Azithromycin orally 1000 mg
Intervention Type
Drug
Intervention Name(s)
Ampicillin
Intervention Description
All patients will receive Ampicillin 2gm IV every 6 hours for 2 days
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin 500 mg orally once
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin 250 mg orally daily for 4 days
Primary Outcome Measure Information:
Title
Days from diagnosis of preterm pre-labor rupture of membranes to delivery.
Time Frame
14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age is between 28 wks and 37wks
Singleton living pregnancy.
Confirmed Premature Pre-labor rupture of membranes (PPROM).
Exclusion Criteria:
previable rupture of membranes (<23+6wks)
Multiple gestations
Macrolide allergy
patient receiving combination macrolide therapy
lethal fetal anomalies
contraindications to expectant management of PPROM at time of diagnosis e.g. concurrent preterm labor, placental abruption, chorioamnionitis or non-reassuring fetal testing
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Azithromycin for Preterm Pre-labor Rupture of Membranes
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