A single-centre randomised controlled trial of Antibiotic Prophylaxis before second-trimester Genetic Amniocentesis in women: the APGA trial

INTERVENTION: Intervention: Oral azithromycin 500 mg daily for the three days prior to the amniocentesis procedure, in three doses taken at 24‐hour intervals. Control: No therapy. Both groups have a scan on the day of the amniocentesis. The women have to be discharged 30 minutes after completion of the procedure. The patients that present any complications, within 4 weeks, must to be checked into the Centre with a scan and PROM test. The coordinators, after 4 weeks, will check by phone that all women will not come back to the centre for prescribed control. All study personnel were blinded to treatment assignment for the duration of the study. CONDITION: Preterm Premature Rupture Of Membranes (pPROM), foetal death ; Pregnancy and Childbirth ; Premature rupture of membranes PRIMARY OUTCOME: To determine the efficacy of antibiotic prophylaxis in second‐trimester amniocentesis in preventing the foetal death in both groups, assessed four weeks after the procedure. SECONDARY OUTCOME: 1. To determine the incidence of pPROM in both groups, defined as a rupture of the membranes, assessed four weeks after the procedure; 2. To evaluate the incidence of foetal death after the pPROM in both groups, assessed four weeks after the procedure INCLUSION CRITERIA: 1. Pregnant women aged greater than or equal to 18 years 2. All women requested a second trimester genetic amniocentesis with the same chosen operator