Antenatal azithromycin to prevent preterm birth in pregnant women with vaginal cerclage: A randomized clinical trial/Vajinal serklajli gebelerde preterm dogumu onlemek icin antenatal azitromisin: Randomize bir klinik calisma

• Published in: Turkish journal of obstetrics and gynecology Vol. 20; no. 1; p. 1
• Main Authors: Ahmed, Rania Hassan Mostafa, Bayoumy, Hassan Awwad, Ashoush, Sherif Ahmed, Gabr, Wessam Kamal Lotfy
• Format: Journal Article
• Language: English
• Published: Galenos Yayinevi Tic. Ltd 01.03.2023
• Subjects: Azithromycin; Cervical cerclage; Dosage and administration; Premature birth; Prevention; Risk factors; Egypt
• ISSN: 2149-9322
• DOI: 10.4274/tjod.galenos.2023.47715

Objective: To assess whether antenatal azithromycin given to pregnant women with vaginal cerclage can reduce preterm birth or not. Materials and Methods: We randomized 50 pregnant ladies who underwent cerclage at Ain Shams University Maternity Hospital in group A (receiving 500 mg Azithromycin oral tablets (Zithrokan[R], Hikma, Egypt) one tablet orally twice daily for three days in 3 courses at 14th, 24th and 32nd week, plus usual antenatal care) and an identical group B (receiving usual antenatal care). Our primary outcome was gestational age at delivery, and secondary outcomes were birthweight, mode of delivery, and maternal, and perinatal complications. This study was registered on ClinicalTrials.gov with number: NCT04278937. Results: Pregnancy was more prolonged in the Azithromycin group (delivery at 36.8 weeks vs 34.1 weeks; p=0.017). Also, a higher birthweight was observed in the Azithromycin group (2932.6 gm vs 2401.8 gm; p=0.006). No significant difference was found between the two groups as regards to other outcomes (miscarriage, stillbirth, neonatal intensive care unit admission, antepartum hemorrhage, postpartum pyrexia, need for blood transfusion). Conclusion: Adding antenatal azithromycin to women undergoing cerclage prolongs pregnancy and reduces the risk of preterm birth, with a slight increase in birthweight. Keywords: Azithromycin, birth weight, cerclage, cervical, premature birth Amac: Bu calismanin amaci vajinal serklaj uygulanan gebelere antenatal azitromisinin erken dogumu azaltip azaltamayacagini degerlendirmektir. Gerec ve Yontemler: Ain Shams Universitesi Dogum Hastanesi'nde serklaj yapilan 50 hamile kadini grup A'ya [500 mg Azitromisin oral tablet (Zithrokan[R], Hikma, Misir) gunde iki kez uc gun boyunca 14., 24. ve 32. haftalarda rutin dogum oncesi bakim ile birlikte uygulandi] ve serklaj yapilan 50 hamile kadin rutin dogum oncesi bakimin uygulandigi grup B'ye randomize edildi. Birincil sonlanim dogumdaki gebelik yasi idi ve ikincil sonlanimlar dogum agirligi, dogum sekli, maternal ve perinatal komplikasyonlardi. Bu calisma ClinicalTrials.gov'da NCT04278937 numarasiyla kayitlidir. Bulgular: Azitromisin grubunda gebelik suresi daha uzundu (36,8 haftaya karsilik 34,1 hafta; p=0,017). Ayrica Azitromisin grubunda daha yuksek dogum agirligi gozlendi (2932,6 g'ye karsilik 2401,8 g; p=0,006). Diger sonlanimlar (dusuk, olu dogum, yenidoganin yogun bakima yatis, antepartum kanama, postpartum pireksi, kan transfuzyonu ihtiyaci) acisindan iki grup arasinda anlamli fark bulunmadi. Sonuc: Serklaj uygulanan kadinlara antenatal azitromisin eklenmesi gebeligi uzatir, dogum agirliginda hafif bir artis saglar ve erken dogum riskini azaltir. Anahtar Kelimeler: Azitromisin, dogum agirligi, serklaj, servikal, erken dogum