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Evaluation of Saffron capsule on cervical ripening.

Evaluation of Saffron capsule on cervical ripening, beginning and delivery outcomes in primiparous women

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201603243860N24
Enrollment
100
Registered
2016-12-09
Start date
2016-04-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical ripening. Primary inadequate contractions

Interventions

Intervention 1: Intervention group: 3 Saffron oral capsules (250 mg) are prescribed and patients should take one capsule every 24 hours for 3 days. These capsules are produced in Shahid Beheshti pharm
Treatment - Drugs
Placebo
Intervention group: 3 Saffron oral capsules (250 mg) are prescribed and patients should take one capsule every 24 hours for 3 days. These capsules are produced in Shahid Beheshti pharmacy faculty.
Control group: Placebo capsule containing 250 mg of lactose powder that have been prepared under the supervision of pharmacist. Three oral capsules are prescribed and patients should take one capsule

Sponsors

Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: primiparous woman; age between 18 to 35 years; gestational age of 40 weeks or more; singleton pregnancy with cephalic presentation; not starting uterine contraction; Bishop score less than or equal 4; intact amniotic sac; normal pattern of fetal heart rate; reactive non-stress test; fetal weight between 2500 to 4000; low-risk pregnancy (without known surgical diseases and internal disease or pregnancy complications such as preeclampsia, placental abruption, previa and the absence of known fetal problems); avoiding the use of herbal medicines, chemical or traditional methods for induction of labor in 36 hours before treatment; lack of sex from 24 hours before the beginning till end of the study. Exclusion criteria: Use of oral Saffron; cephalo-pelvic disproportion; using uterine stimulant drugs during the study, such as castor oil; obstetric emergency cases.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Cervical ripeningat. Timepoint: Before the intervention, three days later. Method of measurement: Bishop score table.

Secondary

MeasureTime frame
Mode of delivery. Timepoint: After intervention. Method of measurement: observation.;Duration and frequency of uterine contractions per hour. Timepoint: During 3 days after starting intervention. Method of measurement: Observation and physical exam.;Duration of the first stage of labor (in minutes). Timepoint: After finishing the first stage of labor. Method of measurement: Patient record.;Duration of the second stage of labor (in minutes). Timepoint: After finishing the second stage of labor. Method of measurement: Observation and physical exam.;Duration of the third stage of labor (in minutes). Timepoint: After finishing the third stage of labor. Method of measurement: Observation and physical exam.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGiti Ozgoli

School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences

g.ozgoli@gmail.com+98 21 8820 2512

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026