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Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes

Y

Yuzuncu Yıl University

Status

Completed

Conditions

Preterm Premature Rupture of Membranes (PPROM)
Prophylaxis
Perinatal Outcomes

Treatments

Drug: Antibiotic regimen 1: sulbactam + ampicillin + azithromycin
Drug: Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT07148622
VYYU-KHD-OK-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Singleton pregnancies,
  • PPROM after 34 weeks of gestation

Exclusion criteria

  • Patients with fetal anomalies
  • Preeclampsia, gestational or pregestational diabetes mellitus,
  • Multiple pregnancies,
  • Chorioamnionitis, placental abruption, cord prolapse, fetal distress, or other complicated pregnancies.
  • Maternal immunodeficiency
  • The presence of other infections requiring antibiotic therapy, antenatal corticosteroid use, chronic diseases,
  • Unwillingness to participate and sign the detailed informed consent form

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Antibiotic regimen 1
Active Comparator group
Treatment:
Drug: Antibiotic regimen 1: sulbactam + ampicillin + azithromycin
Antibiotic regimen 2
Active Comparator group
Treatment:
Drug: Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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