الفهرس 
Comparison between azithromycin vs placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida womenand their effect on maternal and neonatal outcomes A double-blind, placebo-controlled randomized clinical trial
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Abstract
Objectives: The aim of the study is to compare between Azithromycin vs Placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on maternal and neonatal outcomes. Design: A prospective double-blind, placebo-controlled randomized clinical trial (RCT). Setting: Kasr Al-Ainy hospital, Emergency Unit of Obstetrics and Gynecology Cairo University, Egypt, during the period from December 2020 to May 2021. Methods: A total of 324 pregnant women fulfilling the inclusion criteria during the first stage of labor at or more than 37 weeks of gestation. Patients were randomized into 2 equal groups (162 patients each). In the two groups the following outcomes were reached: the incidence of maternal fever, postpartum endometritis, APGAR score at 1 and 5 minutes , neonatal fever, neonatal pneumonia, neonatal skin infection, RDS, meconium aspiration, the need for NICU admission and/or mechanical ventilation and side effects of Azithromycin. Interventions:group (A) (Azithromycin group): Women received Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days). group (B) (Placebo group): Women received placebo capsules (manufactured in pharmacy department with the same shape, colour and consistency as Azithromycin capsule for 3 days). A single pharmacist will be responsible for manufacturing of placebo capsules and packing all medications into sterile boxes and labelling of them as 1 or 2. Results: No statistically significant differences between Azithromycin and placebo groups regarding baseline and delivery characteristics of study participants including maternal age (p=0.085), gravidity (p=0.096), parity (p=0.052), BMI (p=0.362), birth weight (p=0.734), gestational age at delivery (p=0.168), admission to delivery interval (p=0.251), episiotomies and tears (p=0.098 & p=0.147, respectively). Mothers in Azithromycin group had significantly lower incidence of postpartum pyrexia and postpartum endometritis than placebo group (3.7% vs 11.1%; p =0.011) in addition to that of maternal skin infection (episiotomy/tear) (4.3 % vs 12.3%; p=0.009)