The Effect of Oral Crocus Sativus L. (Saffron) Tablet on Cervical Ripening in Term Pregnant Women: A Double -Blind Randomized Controlled Trial

Abstract

Abstract: Background and objective: Perinatal mortality and maternal and neonatal outcomes increased in pregnancies beyond 41 weeks gestational age. It seems to be logical the termination of the pregnancy before the occurrence of such incidents. Readiness of the cervix is required for successful induction of labor. The aim of this study was to assess whether taking saffron orally could affect on the cervical readiness (primary outcome) and some delivery and neonatal outcomes (secondary outcomes) in women with term pregnancy. Materials and Methods: This double-blind randomized controlled trial was carried out on 50 pregnant women with gestational age of 39 to 41 weeks who had no indication for cesarean section were recruited among outpatients presenting to two private offices and a clinic in Shohada hospital of Bonab-Iran for prenatal care. Allocation sequence was determined using a computerized random program considering block randomization with block sizes of 4 and 6 and allocation ratio of 1:1. Stratified by having a history of previous delivery (Yes/No). Participants in the intervention group (25 women) received saffron, in pill form 250 mg and participants in the control group (25 wonen) received placebo three times in 24 hours (one every eight hours). The readiness of cervix assessed by bishop score at 10-12 and 20-24 hours after initiation of intervention and just after onset of uterine active contractions. Interval between starting the intervention and onset of active uterine contractions was determined. Duration of first and second stages of delivery was assessed using Partograph. Any other intervention including using misoprostol or oxytocin for augmentation or induction and the delivery type were recorded. At time of admission to the hospital and 12-24 hours after delivery, we took a blood sample from the women to measure hemoglobin and hematocrit. After delivery, the first and fifth Apgar score, and weight of the infants were checked by the investigators. Also, any procedure used for neonatal resuscitation were recorded. SPSS-ver 16 software was used for data analysis and Independent T-test, ANCOVA, Mann-Whitney U test, Fisher exact test, Chi-square and trend Chi-square tests were used. Results: The groups were similar in terms of demographic and fertility characteristics and vital signs. In term of bishop score, the differece between the groups was not statistically significant at the baseline (p=0.792) and the 10-12 hours (p=0.159). The score was significatly higher in the saffron group at the 20-24 hours (p=0.029) and at just after starting active uterine contractions (p=0.003). There was no cesarean section and one labor augmentation in the saffron group. The corresponding figures were three and three in the placebo group. However, the differences were not statistically significant (p=0.117 and p=0.609, respectively). There was no statistically significant difference between the groups in terms of timing of starting spontaneous active uterine contractions (p=0.372), duration of the first (p=0.173) and second (p=0.615) stages of labor, and hemoglobin (p=0.854), hematocrit (p=0.878) at 12-24 hours after delivery and neonatal outcomes. Conclusion: Saffron can increase readiness of cervix in term pregnancies. However, the study limitations do not allow for any definite conclusion for its use in clinical practice and more researches are needed to assess its effect on delivery and neonatal outcomes.