Status:
NOT_YET_RECRUITING
Latency Antibiotics for Previable Rupture Of Membranes Trial
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Preterm Prelabor Rupture of Membranes (PPROM)
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if...
Eligibility Criteria
Inclusion
- Preterm premature rupture of membranes at less than 22 weeks.
- Membrane rupture had occurred within 36 hours of randomization.
- Cervical dilatation is 3 cm or less (on visual or clinical examination).
- 4 or fewer contractions in the 60-minute monitoring period before randomization.
- Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age
- Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information.
Exclusion
- Nonreasoning fetal testing
- Vaginal bleeding
- Maternal or fetal indication for immediate delivery
- Cervical cerclage in place
- Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin)
- Allergy to Penicillins or Azithromycin
- Febrile illness requiring antibiotics
- Placenta previa
- Multifetal gestation
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06917157
Start Date
May 1 2025
End Date
May 31 2027
Last Update
April 8 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030