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Evaluation of the effect of saffron oral capsules on pain severity and labor duration

Evaluation of the effect of saffron oral capsules on pain severity and duration of the active phase of labor first stage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201205229830N1
Enrollment
60
Registered
2014-03-10
Start date
2013-11-06
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

delivery. Other single spontaneous delivery

Interventions

Intervention 1: Capsules 250 mg of the drug (saffron) every 2 hours and up to 3 doses, the intensity of uterine contractions and the progress of labor is consumed orally by the research unit. Interve
Placebo
Capsules 250 mg of the drug (saffron) every 2 hours and up to 3 doses, the intensity of uterine contractions and the progress of labor is consumed orally by the research unit
Capsules 250 mg of the pelacebo every 2 hours and up to 3 doses, the intensity of uterine contractions and the progress of labor is consumed orally by the research unit

Sponsors

Research Council of Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Completing the written informed consent to participate in the study?age of 18-35 years; body mass index of 19.5- 30;gestational age of 37-42 weeks; having no history of pregnancy more than 20 weeks of gestation; singleton pregnancy; cervical dilatation of 3-4 cm; cephalic presentation. Exclusion criteria: using any herbal drug during the past 48 hours; addiction or using a variety of tobacco and alcohol; maternal pregnancy complications (preeclampsia, bleeding during pregnancy, threat to abortion, premature rupture of fetus membranes more than 12 hours before admission of mother), having or history of any systemic disease (diabetes, hypertension, heart and kidney disease, etc), history of mental disorder, speaking, hearing and mental disorder, disproportion of maternal pelvic with fetal head; estimated fetal weight less than 2500 g and more than 4000 g (according to Johnson rules); fetal heart rate abnormalities; any abnormalities in the fetus (based on sonography; obstetric problems; multiple pregnancy; previous surgery on the uterus; cervix and delivery canal; cesarean indication; allergic reaction to the saffron

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain intensity of labor. Timepoint: 1 hour intervals during the intervention. Method of measurement: Pain intensity using a visual pain scale.;Duration of the active phase of labor first stage. Timepoint: 1-2 hour intervals during the intervention. Method of measurement: During the active phase of labor and vaginal exam registration.

Secondary

MeasureTime frame
Uterine contractions. Timepoint: During each 30-minute intervention. Method of measurement: Tocodynamomtr device and touch the hand.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSedigheh Ahmadi

Mashhad University of Medical Sciences

Ahmadis901@mums.ac.irahmadisedigh64@gmail.com.azharis@mums.ac.ir/ azharis@mums.ac.ir+51 1 8591511

Outcome results

None listed

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