NCT07148622

Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes

Randomized Controlled Trial on the Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes After 34 Weeks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Yuzuncu Yil University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation.

Detailed description

Background: To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation. Methods: A total of 40 pregnant women diagnosed with PPROM after the 34th week of gestation were included in the study and randomly divided into two equal groups. Group-1: Sulbactam + ampicillin, azithromycin, and amoxicillin. Group-2: Ceftriaxone, clarithromycin, and amoxicillin. For all cases, obstetric history, time of delivery, latency period, infection markers, neonatal birth weight, APGAR scores, NICU requirement and length of stay, type of delivery and maternal complications were recorded.

Conditions

• Preterm Premature Rupture of Membranes (PPROM)
• Prophylaxis
• Perinatal Outcomes

Interventions

Type	Name	Description
DRUG	Antibiotic regimen 1: sulbactam + ampicillin + azithromycin	For the first 48 hours, 4×2 g IV sulbactam + ampicillin, 1 g oral azithromycin on day 1, and from days 3-7, 3×500 mg oral amoxicillin
DRUG	Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin	For the first 48 hours, 1×1 g IV ceftriaxone + 2×500 mg oral clarithromycin, and from day 3 onwards, 3×500 mg oral amoxicillin + 2×500 mg oral clarithromycin.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-08-01
• Completion: 2025-08-10
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

1 site across 1 country: Turkey (Türkiye)