Combined treatment with cervical pessary and vaginal progesterone for the prevention of preterm birth: A randomized clinical trial

• Published in: The journal of obstetrics and gynaecology research Vol. 42; no. 12; pp. 1673 - 1679
• Main Authors: Karbasian, Niloofar, Sheikh, Mahdi, Pirjani, Reihaneh, Hazrati, Shahla, Tara, Fatemeh, Hantoushzadeh, Sedigheh
• Format: Journal Article
• Language: English
• Published: Australia Blackwell Publishing Ltd 01-12-2016; Wiley Subscription Services, Inc
• Subjects: Adult; Birth; Birth weight; Cervical Length Measurement; Cervix; Chorioamnionitis; Clinical trials; Combined Modality Therapy; delivery; Female; Fetuses; high risk; Humans; Neonates; Pregnancy; Pregnancy Outcome; premature; Premature birth; Premature Birth - drug therapy; Premature Birth - prevention & control; Premature Birth - surgery; Progesterone; Progesterone - administration & dosage; Progesterone - therapeutic use; Prospective Studies; second trimester; short cervix; Statistical analysis; Treatment Outcome; Uterine Cervical Incompetence - surgery; Vagina; delivery; premature; short cervix; second trimester; high risk
• ISSN: 1341-8076; 1447-0756
• DOI: 10.1111/jog.13138

Aim
We compared the effectiveness of a combined treatment involving cervical pessary plus vaginal progesterone to vaginal progesterone alone in decreasing the rate of preterm birth in women with short cervix in the second gestational trimester.
Methods
This prospective, open‐label, randomized clinical trial was conducted on 144 pregnant women with singleton pregnancy who had a cervical length ≤ 25 mm, at 18–22 gestational weeks (GW). Seventy‐three patients were assigned to receive 400 mg of daily vaginal progesterone (group A), and 73 to receive cervical pessary plus 400 mg of daily vaginal progesterone (group B), until the 37th GW. The patients were then followed until delivery.
Results
The rates of preterm birth were 16.4% in group A and 19.7% in group B, which were not statistically different (P = 0.6). There were no statistically significant differences in the rates of preterm birth at <37, <34, <32, and ≤26 GW between participants randomized to each group (P = 0.55). The rates of low‐birthweight delivery were 17.8% in group A, and 23.9% in group B, which were not statistically different (P = 0.36). The rates of premature rupture of membranes, chorioamnionitis, the requirement for neonatal intensive care unit admission, and fetal and neonatal deaths were similar between the two groups.
Conclusion
In pregnancies with short cervix at mid‐pregnancy, combination therapy of cervical pessary plus daily vaginal progesterone does not have any additional benefit over daily vaginal progesterone alone in reducing the rate of preterm birth and adverse pregnancy outcomes.