Efficacy of adjunctive use of vaginal progesterone after cervical cerclage for prevention of 2nd trimester miscarriage due to preterm labour.

Abstract

Objective: To assesses the effectiveness of adjunctive vaginal progesterone following cervical cerclage in preventing second-trimester miscarriages as a result of preterm labor (PTL). Study Design: Randomized Control Trial. Setting: Lady Wallington Hospital, King Edward Medical University, Lahore. Period: July to Dec, 2024. Methods: The trial group (vaginal progesterone + cervical cerclage) and the control group (cervical cerclage only) were randomized to two equal groups. In order to mitigate bias, double-blinding was implemented. The principal result was the absence of preterm labor during the pregnancy. The chi-square test was employed to analyze the data, with a p-value of less than 0.05 being considered significant. Results: At the time of cerclage application, the mean gestational age was 14.22 ± 3.85 weeks, and the mean maternal age was 29.83 ± 3.96 years. The trial group demonstrated a considerably higher efficacy (90%) than the control group (26.7%), with a p-value of less than 0.001. In comparison to the later application (16 ± 3.89 weeks, p=0.002), the efficacy of cervical cerclage was higher when applied at an earlier gestational age (12.94 ± 3.36 weeks). The trial group had a substantially higher gestational age at delivery (35.7 ± 1.72 weeks) than the control group (34.3 ± 2.65 weeks, p=0.003). The outcomes were influenced by parity (p=0.008), while there was no significant association between maternal age and previous cerclage history. Conclusion: Adjunctive vaginal progesterone significantly improves outcomes in preventing PTL when combined with cervical cerclage, particularly when applied earlier in pregnancy. Further large-scale, multi-center studies are recommended to confirm these findings and guide clinical practice.