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IRCT20230129057268N1 IRCT 2023-02-11 Yazd University of Medical Sciences Comparison of azithromycin and erythromycin effect in reducing complications of preterm premature rupture of membranes: a clinical trial study Comparison of azithromycin and erythromycin effect in reducing complications of preterm premature rupture of membranes: a clinical trial study 2023-02-09 anticipated 30 Complete https://irct.ir/trial/68331 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: No, Randomization description: women randomly will be divided into two groups by considering 8 random blocks of size 8 and each person in each group will receive the desired treatment, Blinding description: Pregnant women receiving erythromycin and azithromycin regimens will be blinded. 1-2 preterm premature rupture of membranes (PPROM). Intervention 1: This study is a randomized clinical trial. group A (n=30), PPROM patients with a gestational age more than 24 weeks will treat with 1000 mg azithromycin orally as a single dose. Aditionally, they will receive intravenous ampicillin 2 g every 6 hours for 2 days and then oral amoxicillin 250 mg every 8 hours for 5 days. Then this group, will be compared with group B in terms of primary outcomes including latency period and clinical chorioamnionitis and secondary outcomes including the presence or absence of amniotic fluid stained with meconium, postpartum endometritis, and neonatal sepsis, type of delivery, condition of the newborn, weight of the newborn . Intervention 2: Intervention group: group B (n=30), PPROM patients with a gestational age more than 24 weeks will treat with 400mg erytromycin orally every 6 hour for 7 days. Aditionally, they will receive intravenous ampicillin 2 g every 6 hours for 2 days and then oral amoxicillin 250 mg every 8 hours for 5 days. Then this group, will be compared with group A in terms of primary outcomes including latency period and clinical chorioamnionitis and secondary outcomes including the presence or absence of amniotic fluid stained with meconium, postpartum endometritis, and neonatal sepsis, type of delivery, condition of the newborn, weight of the newborn. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I will decide after starting the study.
public Atiye Javaheri
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) 8915173143 38203414 atiyeh56@gmail.com Yazd University of Medical Sciences scientific Atiye Javaheri
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 atiyeh56@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Women with a gestational age of more than 24 weeks will be included in this study. no limit no limit Female Women with a gestational age of less than 24 weeks, women with a cerclage, history of smoking, trauma or injury that led to PPROM , a congenital or fatal fetal anomaly, and those that consumed other antibiotics before referral, will be excluded from the study. Treatment - Drugs Treatment - Drugs This study is a randomized clinical trial. group A (n=30), PPROM patients with a gestational age more than 24 weeks will treat with 1000 mg azithromycin orally as a single dose. Aditionally, they will receive intravenous ampicillin 2 g every 6 hours for 2 days and then oral amoxicillin 250 mg every 8 hours for 5 days. Then this group, will be compared with group B in terms of primary outcomes including latency period and clinical chorioamnionitis and secondary outcomes including the presence or absence of amniotic fluid stained with meconium, postpartum endometritis, and neonatal sepsis, type of delivery, condition of the newborn, weight of the newborn . Intervention group: group B (n=30), PPROM patients with a gestational age more than 24 weeks will treat with 400mg erytromycin orally every 6 hour for 7 days. Aditionally, they will receive intravenous ampicillin 2 g every 6 hours for 2 days and then oral amoxicillin 250 mg every 8 hours for 5 days. Then this group, will be compared with group A in terms of primary outcomes including latency period and clinical chorioamnionitis and secondary outcomes including the presence or absence of amniotic fluid stained with meconium, postpartum endometritis, and neonatal sepsis, type of delivery, condition of the newborn, weight of the newborn. Latency period. Timepoint: The interval between the rupture of the membranes and the onset of labor. Method of measurement: Length of latency was calculated in days by subtracting the time of delivery from the time of membrane rupture. Clinical chorioamnionitis. Timepoint: Before delivery. Method of measurement: Clinical chorioamnionitis will be determined by clinical symptoms including fever and tachycardia and . Type of delivery. Timepoint: Delivery time. Method of measurement: Observation. Amniotic fluid with meconium. Timepoint: Before delivery. Method of measurement: Amniotic fluid stained with meconium will be determined by clinical symptoms such as fetal distress, observation of meconium discharged from amniotic fluid. Postpartum endometritis. Timepoint: 48 to 72 hours after delivery. Method of measurement: Postpartum endometritis will be determined by the mother's fever, mother's abdominal pain, mother's unpleasant odor secretions. Neonatal sepsis. Timepoint: 72 hours after birth. Method of measurement: Neonatal sepsis will be determined by ذlood culture. Neonatal mortality. Timepoint: After delivery. Method of measurement: Observation. Yazd University of Medical Sciences Approved 2022-05-11 Ethics Committee of the Shahid Sadoughi University of Medical Sciences School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blv. Alem Square, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)