1 Background: The American College of Obstetricians and Gynecologists recommends broad-spectrum antibiotics in cases of preterm prelabor rupture of membranes because the infection is polymicrobial. Many antibiotic regimens have been evaluated to prolong the latency to delivery. Nowadays, azithromycin is used instead of erythromycin due to erythromycin shortages, its ease of administration, decreased cost, and better side effect profile.
From the above evidence, there is a need for evaluation of the effect of different protocols of azithromycin in the management of preterm prelabor rupture of membranes.
2 Objective: To evaluate the efficacy of different azithromycin protocols for the conservative management of preterm prelabor rupture of membranes.
3 Study Design: It was a single-blinded randomized clinical trial including pregnant women at 24–36+6 weeks with viable singleton pregnancies and confirmed preterm prelabor rupture of membranes who attended the Aswan University Hospital from January 01, 2020, to June 01, 2021. The participants were randomized into two groups as follows: Group I was made of women that received Azithromycin 1000 mg PO once and Group II of women that received Azithromycin 500 mg PO once, followed by Azithromycin 250 mg PO daily for four days. The main study outcome was the length of the latency period from the diagnosis of preterm prelabor rupture of membranes to delivery (days). The outcome data were analyzed using the independent samples t-test. The collected data were coded, processed, and analyzed using SPSS (Statistical Package for Social Sciences) version 22 for Windows® (IBM SPSS Inc., Chicago, IL, USA). Data were tested for normality of distribution using the ShapiroWilk test. Qualitative data were represented as frequencies and percentages. The chi-square (χ2) test was used to calculate differences between two or more groups of qualitative variables. Quantitative data were expressed as the mean ± SD (Standard deviation). The independent samples t-test was used to compare between two independent groups of normally distributed variables (parametric data). Comparisons between quantitative variables were performed using the one-way analysis of variance to test the difference between the means of several subgroups of a variable. P-values of < 0.05 were considered statistically significant.
4 Results: The latency period in Group I was significantly higher than that in Group II (5.80 ± 5.44 days vs. 2.88 ± 2.37; respectively, p = 0.000). The mean gestational age at the time of delivery was significantly higher in Group I (p = 0.000). However; the rates of postpartum endometritis and respiratory distress syndrome (RDS) were significantly higher in Group II (p = 0.003 and p = 0.000, respectively).
5 Conclusion: Antibiotic regimens such as ampicillin (ampicillin 2 gm IV every 6 hrs for 2 days) and azithromycin (azithromycin 1000 mg PO once) are effective in prolonging the latency period, decreasing the incidence of chorioamnionitis, and improving improve neonatal outcomes in women with preterm prelabor rupture of membranes .
First Posted: December 17, 2019
Date of registration: January 01, 2020
Date of initial participant enrollment: January 30, 2020
Clinical trial identification number:
Clinical trial.gov: NCT04202380.
URL of the registration site: https://www.clinicaltrials.gov/ct2/show/NCT04202380
Data sharing information: Individual participant data available, other documents available (e.g., study protocol, statistical analysis plan, etc.)