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NCT Number: NCT07148622

Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University

Van, 65100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic regimen 1: sulbactam + ampicillin + azithromycin

Drug

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

Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin

Drug

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.

Primary outcomes

  1. mode of birth checklist

    Time frame: From enrollment to the end of treatment at 4 weeks"

    Effect of different antibiotic regimens on fetal and maternal outcomes: mode of birth checklist

  2. neonatal birth weight

    Time frame: From enrollment to the end of treatment at 4 weeks"

    neonatal birth weight

  3. 1st and 5th minute APGAR scores

    Time frame: From enrollment to the end of treatment at 4 weeks"

    1st and 5th minute APGAR scores

  4. need for NICU (neonatal intensive care unit) admission

    Time frame: From enrollment to the end of treatment at 4 weeks"

    need for NICU (neonatal intensive care unit) admission

  5. duration of NICU stay

    Time frame: From enrollment to the end of treatment at 4 weeks"

    duration of NICU stay.

  6. White blood cell (WBC) count

    Time frame: From enrollment to the end of treatment at 4 weeks"

    White blood cell (WBC) count was measured every 48 hours

  7. C-reactive protein (CRP) levels

    Time frame: From enrollment to the end of treatment at 4 weeks"

    C-reactive protein (CRP) level was measured every 48 hours

  8. Maternal complications

    Time frame: From enrollment to the end of treatment at 4 weeks"

    Maternal complications; chorioamnionitis, placental abruption

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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