Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes

NCT07148622 | Completed

• 1 other identifier: VYYU-KHD-OK-11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Preterm premature rupture of membranes, prophylaxis, perinatal outcomes

Outcome Measures

Primary Outcomes (8)

• mode of birth checklist

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

  From enrollment to the end of treatment at 4 weeks"

• neonatal birth weight

  neonatal birth weight

  From enrollment to the end of treatment at 4 weeks"

• 1st and 5th minute APGAR scores

  1st and 5th minute APGAR scores

  From enrollment to the end of treatment at 4 weeks"

• need for NICU (neonatal intensive care unit) admission

  need for NICU (neonatal intensive care unit) admission

  From enrollment to the end of treatment at 4 weeks"

• duration of NICU stay

  duration of NICU stay.

  From enrollment to the end of treatment at 4 weeks"

• White blood cell (WBC) count

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

  From enrollment to the end of treatment at 4 weeks"

• C-reactive protein (CRP) levels

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

  From enrollment to the end of treatment at 4 weeks"

• Maternal complications

  Maternal complications; chorioamnionitis, placental abruption

  From enrollment to the end of treatment at 4 weeks"

Study Arms (2)

Antibiotic regimen 1

ACTIVE COMPARATOR

Drug: Antibiotic regimen 1: sulbactam + ampicillin + azithromycin

Antibiotic regimen 2

ACTIVE COMPARATOR

Drug: Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin

Interventions

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 1

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.

Antibiotic regimen 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancies,
• PPROM after 34 weeks of gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, 65100, Turkey (Türkiye)

Location

Related Publications (2)

• Lee J, Romero R, Kim SM, Chaemsaithong P, Yoon BH. A new antibiotic regimen treats and prevents intra-amniotic inflammation/infection in patients with preterm PROM. J Matern Fetal Neonatal Med. 2016 Sep;29(17):2727-37. doi: 10.3109/14767058.2015.1103729. Epub 2015 Dec 2.

  PMID: 26441216 RESULT

• Sgayer I, Francis YN, Miron D, Shprits E, Sheffer VF, Rechnitzer H, Lowenstein L, Wolf MF. Compared perinatal outcomes of two prophylactic antibiotic regimens for preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100900. doi: 10.1016/j.ajogmf.2023.100900. Epub 2023 Feb 13.

  PMID: 36791845 RESULT

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Ampicillin; Azithromycin; Clarithromycin; Amoxicillin

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: YuzuncuYıl

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 29, 2025
• Study Start: October 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 10, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)