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Different azithromycin protocols for management of preterm prelabour rupture of membranes: a randomized clinical
Laila Ezzat Abdelfattah1, Rehab Abdelhamid Aboshama2, Amr S Abdelbadie3
1Associate professor of Obstetrics and Gynecology, Department of Obstetrics and Gynecology, Faculty of Medicine, Fayoum University, Fayoum, Egypt. lailaezzat972000@gmail.com.
Background:
Preterm prelabor rupture of membranes is associated with polymicrobial infection; hence broad-spectrum antibiotics are recommended. Nowadays, Azithromycin is used instead of Erythromycin due to erythromycin shortages, its ease of administration, decreased cost, and better side effect profile. This study aimed to evaluate the efficacy of different azithromycin protocols for the conservative management of preterm prelabor rupture of membranes.
Methods:
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 from January 01, 2020, to June 01, 2021. The participants were randomized into two groups: Group I was made of women who received Azithromycin 1000 mg PO once, and Group II of women who received Azithromycin 500 mg PO once, followed by Azithromycin 250 mg PO daily for four days. The primary study outcome was the length of the latency period from the diagnosis of preterm prelabor rupture of membranes to delivery (days).
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 = 0.0001). The mean gestational age at the time of delivery was significantly higher in Group I (p = 0.0001). However, postpartum endometritis and respiratory distress syndrome (RDS) rates were significantly higher in Group II (p = 0.003 and p = 0.0001, respectively).
Conclusion:
The higher dose of Azithromycin was associated with better maternal and neonatal outcomes.
Trial Registration:
Clinical trial identification number: Clinical trial.gov: NCT04202380 (17/ 12/ 2019). Date of registration: 1/1 /2020. Date of initial participant enrollment30 /1/2020. URL of the registration site: https://www.
Clinicaltrials:
gov/ct2/show/NCT04202380.
Insights
A higher dose of azithromycin (1000 mg once) in managing preterm prelabor rupture of membranes significantly extended the latency period to delivery. This improved maternal and neonatal outcomes compared to a lower dose regimen.
Area of Science:
- Obstetrics and Gynecology
- Maternal-Fetal Medicine
- Pharmacology
Background:
- Preterm prelabor rupture of membranes (PPROM) is frequently linked to polymicrobial infections, necessitating broad-spectrum antibiotic use.
- Azithromycin is increasingly utilized over Erythromycin for PPROM management due to availability, cost-effectiveness, and a favorable side effect profile.
Purpose of the Study:
- To compare the efficacy of two distinct azithromycin dosing protocols for the conservative management of PPROM.
- To evaluate the impact of different azithromycin regimens on latency period, gestational age at delivery, and maternal and neonatal complications.
Main Methods:
- A single-blinded randomized clinical trial was conducted involving pregnant women (24-36+6 weeks) with confirmed PPROM.
- Participants were randomized into two groups: Group I received a single 1000 mg dose of azithromycin, while Group II received 500 mg once, followed by 250 mg daily for four days.
- The primary endpoint was the latency period (days) from PPROM diagnosis to delivery.
Main Results:
- Group I demonstrated a significantly longer latency period (5.80 ± 5.44 days) compared to Group II (2.88 ± 2.37 days; p=0.0001).
- Mean gestational age at delivery was significantly higher in Group I (p=0.0001).
- Group II exhibited significantly higher rates of postpartum endometritis (p=0.003) and respiratory distress syndrome (RDS) in neonates (p=0.0001).
Conclusions:
- A higher single dose of azithromycin (1000 mg) is associated with improved maternal and neonatal outcomes in PPROM conservative management.
- The findings suggest that higher-dose azithromycin protocols may be more effective in prolonging pregnancy and reducing complications in PPROM.
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