Effect of Azithromycin versus Placebo on Maternal and Neonatal Outcomes among Multigravida Women with Meconium-Stained Amniotic Fluid during the First Stage of Labor: A Double-Blind Randomized Controlled Trial | ||
| Evidence Based Women's Health Journal | ||
| Articles in Press, Accepted Manuscript, Available Online from 13 October 2025 | ||
| Document Type: Original Article | ||
| DOI: 10.21608/ebwhj.2025.431318.1520 | ||
| Authors | ||
| Ahmed Samir Rashwan* 1; Ahmed Kamal Zaghloul2; Gamal Gamal Youssef2; Eman Aly Hussein2; Mazen Abdel-Rasheed3; Abdelfatah Eldesouky4 | ||
| 1Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt | ||
| 2Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt | ||
| 3Reproductive Health Research Department, National Research Centre, Cairo, Egypt | ||
| 4Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt | ||
| Abstract | ||
| Background: Meconium-stained amniotic fluid (MSAF) is associated with increased risks of maternal and neonatal infectious morbidities. Antibiotic prophylaxis during labor has been proposed to reduce these complications, but evidence remains limited. Objective: To evaluate the efficacy of Azithromycin versus placebo in reducing maternal and neonatal infections among multigravida women presenting with MSAF during the first stage of labor. Methods: This prospective, double-blind, placebo-controlled randomized clinical trial was conducted at Kasr Al-Ainy Hospital, Cairo University, Egypt, between March 2021 and October 2021. A total of 324 pregnant women at ≥37 weeks of gestation were randomized into two equal groups (n = 162 each). • Azithromycin group (Group A): Received Azithromycin 250 mg every 12 hours on an empty stomach for 3 days. • Placebo group: Received identical placebo capsules. Results: Baseline maternal and delivery characteristics were comparable between groups. Azithromycin significantly reduced the incidence of postpartum pyrexia and endometritis (3.7% vs 11.1%; p = 0.011) and perineal wound infection (4.3% vs 12.3%; p = 0.009). Neonates of treated mothers had higher Apgar scores at 1 and 5 minutes (7.47 ± 0.82 and 8.98 ± 0.85 vs 7.10 ± 1.98 and 8.47 ± 1.61) and lower rates of RDS (3.7% vs 9.3%; p = 0.042), meconium aspiration (1.9% vs 7.4%; p = 0.017), pneumonia (1.9% vs 6.2%; p = 0.048), and skin infection (3.1% vs 10.5%; p = 0.008). Conclusions: Prophylactic Azithromycin administration in women with MSAF during labor significantly decreased maternal and neonatal infectious morbidities compared with placebo. | ||
| Keywords | ||
| Azithromycin; Meconium-stained amniotic fluid; Postpartum endometritis; NICU admission | ||
|
Statistics Article View: 1 |
||
