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Status unknownNCT04528251Updated Aug 27, 2020

Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes

An observational study in Preterm Membrane Rupture and Neonatal Sepsis, sponsored by Hacettepe University. Status unknown at 1 site in Turkey. Open to participants aged 1 Minute to 15 Minutes, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-27.

Sponsored by Hacettepe University · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
1 Minute to 15 Minutes
Sex
All
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Study summary

There is no consensus around the world on the treatment of preterm rupture of membranes, which is one of the important causes of early neonatal sepsis and one of the common causes of prematurity. Different countries, hospitals and physicians can determine different treatment approaches. There is very little scientific data on the benefit of commonly used treatment regimens other than experience. In this study, scientific results will be obtained by comparing the efficacy of treatments (Sulbactam ampicillin or azithromycin ampicillin) in two different hospitals (Hacettepe University Perinatology Clinic and Ankara City Hospital Perinatology Clinic), and it will be shown which treatment regimen reduces early neonatal sepsis and inflammation better. Some samples (vaginal IL-6, vaginal-cervical swab samples for atypical bacteria, cervical swab samples for direct microscopy, serum IL-6) will be taken from pregnant women who develop membrane rupture and these samples will be used as initial inflammation markers. Each physician will decide on the treatment of his own patient, there will be no intervention in the treatment of the patient within the scope of the research. Patients will continue their routine follow-up after receiving their treatment. When the delivery occurs, the level of IL-6 in the cord blood will be examined with other inflammation markers (procalcitonin, crp, complete blood count), and the neonatal inflammation status of the baby will be determined. The low inflammation markers detected in the babies of pregnant women with high initial inflammation values will be compared and it will be determined which treatment is more effective. At the same time, routine neonatal intensive care follow-ups of these babies will be continued and treatment efficiency in terms of early neonatal sepsis will be determined. This study will present scientific data on which treatment is effective in the literature and will guide international treatment guidelines. At the same time, preterm rupture of membranes will show which bacterial agent plays a more role in the etiology and which of the inflammation markers have more sensitivity and specificity, as well as the success of the treatment, which is the subject of the study. The routine use of some examinations (such as cervical PCR) performed before the treatment begins, is a guide in the selection of agent-specific treatment and may shorten the unnecessary drug use and hospital stay; The management of patients may vary according to the initial inflammation parameters. Physicians evaluating the results of this study can evaluate the risk of their babies in terms of early neonatal sepsis according to the initial inflammation values of their patients, and increase and decrease the length of hospital stay.

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Conditions studied

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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 120 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Minute to 15 Minutes
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients who applied to study centers with PPROM and started antibiotic treatment and their newborn babies will be included.

Inclusion criteria

  • Having received azithromycin-ampicillin or sulbactam-ampicillin treatment during antenatal period with the diagnosis of preterm rupture of membranes that started before 34 weeks.

Exclusion criteria

Exclusion Criteria:

  • Having a disease detected in the perinatal or neonatal period (such as hydrops, congenital anomalies)
  • Having a history of iatrogenic preterm birth
  • Lethal or chromosomal anomaly
  • Being diagnosed with perinatal hypoxia, hypoxic ischemic encephalopathy
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. maternal vaginal IL-6, vaginal-cervical swab samples for atypical bacteria, cervical swab samples for direct microscopy, serum IL-6

    maternal inflammation markers

    Time frame: 1 hour

  2. level of IL-6 in the cord blood, procalcitonin, crp, complete blood count

    neonatal inflammation markers

    Time frame: 1 hour

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Study locations

1 of 1 sites recruiting
  • Hacettepe University
    Ankara, 06230, Turkey
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04528251
Lead sponsor
Hacettepe University
Responsible party
H. Tolga Çelik (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Aug 27, 2020
Start date
Sep 1, 2020 (estimated)
Primary completion
Aug 1, 2021 (estimated)
Completion
Aug 1, 2021 (estimated)
Last update
Aug 27, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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