Azithromycin for genital mycoplasma intraamniotic infection in pregnant women with preterm premature rupture of membranes: a multi-centric, randomized, controlled, open label, clinical trial

Abstract

BACKGROUND. Preterm premature rupture of membranes defined as rupture of membranes before the onset of labour is a complication of pregnancy whose main consequences are prematurity of the infant and infection of the amniotic fluid. The management in most of the cases is aimed to prolong the gestation to reduce the mortality and morbidity related to prematurity, as well as to reduce the incidence of chorioamnionitis which increases as the gestation is prolonged. This is why antibiotics are an important tool to prevent chorioamnionitis and to treat subclinical intraamniotic infections. Nevertheless, the antibiotic therapy of choice is not well stablished. Moreover, even if genital mycoplasma is the main microorganism identified as an agent implicated in the etiology of this pathology, most of the management protocols do not include specific tests to determine its presence, therefore, the possibility of a specific targeted therapy is not possible. OBJECTIVES. The aim of this study is to compare the differences in latency period with targeted antibiotic with azithromycin and empiric antibiotic treatment in the management of singleton pregnancies with preterm premature rupture of membrane between 23 and 34 weeks of gestation with positive PCR in amniotic fluid for genital mycoplasma. STUDY DESING AND POPULATION. A randomized, open label and controlled clinical trial will be done. It will be a multi-centric study involving the four provincial hospitals of Catalonia between June 2020 and May 2022. The sample size will be of 192 pregnant women who meet inclusion but not the exclusion criteria. METHODS. Patients included in this study will be randomly assign to one group of intervention. 96 patients will receive empiric antibiotic (therapy A) and 96 patients will receive intravenous azithromycin (therapy B). The main outcome will be latency period (defined as time between the rupture of membranes and labour). The following covariates will be considered: age, body mass index, ethnicity, parity, time between onset of the symptoms and antibiotic initiation, socioeconomic status and sexual risk behaviour