Effect of Saffron (Fan Hong Hua) On the Readiness of The Uterine Cervix In Term Pregnancy: A Placebo-Controlled Randomized Trial

BACKGROUND: Readiness of the cervix is required for successful induction of labor, and there are a number of ways in which this can be achieved. OBJECTIVES: The aim of the present study was to assess whether taking saffron orally could have an effect on the cervical readiness (primary outcome) and some delivery and neonatal outcomes (secondary outcomes) in women in the stage of term pregnancy. PATIENTS AND METHODS: In this double-blind trial, 50 women with a gestational age of 39 to 41 weeks, no indication of cesarean section, a Bishop’s score of less than 4, who had plan to have vaginal delivery at Shohada hospital of Bonab, Iran were randomized into two groups receiving three 250mg saffron or placebo pills in 24 hours. The readiness of the cervix was assessed using the Bishop’s score. The Mann-Whitney U test was used to compare the scores between the groups. RESULTS: There were no significant differences between the groups in terms of the Bishop’s score at the baseline (P = 0.792) and 10-12 hours after starting the intervention (P = 0.159). The Bishop’s score was significantly higher in the saffron group 20 - 24 hours after the intervention was started (P = 0.029) and just after onset of active uterine contractions (P = 0.003). In the saffron group, there was no cesarean section and 1 meconium staining of the fetus, but 3 and 4, respectively, in the placebo group. There was no statistically significant difference between the groups in terms of the timing of the onset of spontaneous active uterine contractions, the duration of the first and second stages of labor, the need for delivery augmentation, and the first and fifth minutes of neonatal Apgar (P > 0.05). No adverse event was reported in any of the groups. CONCLUSIONS: Saffron can increase the readiness of the cervix in term pregnancies. However, the study limitations do not allow for any definite conclusions for its use in clinical practice, and more research is needed to assess its effect on delivery and neonatal outcomes.