NCT04528251

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

Status unknown Last updated 27 August 2020

What this trial tests

trial in Preterm Membrane Rupture in 120 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
1 August 2021

1 August 2021

Quick facts

Lead sponsor	Hacettepe University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	120
Start date	1 September 2020
Primary completion	1 August 2021
Estimated completion	1 August 2021
Sites	1 location across Turkey (Türkiye)

Conditions studied

• Preterm Membrane Rupture — all drugs for Preterm Membrane Rupture →
• Neonatal Sepsis — all drugs for Neonatal Sepsis →

Sponsor

Hacettepe University

Who can join

Adults 1 Minute to 15 Minutes, any sex, with Preterm Membrane Rupture or Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.