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The effect of saffron syrup on the labor pain intensity, anxiety and duration of labor

The effect of saffron syrup on the labor pain intensity, anxiety and duration of labor in primiparous women: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201507073706N26
Enrollment
96
Registered
2016-02-03
Start date
2016-02-01
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

Normal labor and delivery. Spontaneous vertex delivery

Interventions

Intervention 1: The first intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras)containing 750 mg saffron and 200 mg of sugar palms in 240 ml syrup. 80 ml of the syrup will be tak
Treatment - Drugs
The first intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras)containing 750 mg saffron and 200 mg of sugar palms in 240 ml syrup. 80 ml of the syrup will be taken when cervical
The second intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras) containing 750 mg saffron and artificial sugar (Isonalt) in 240 ml syrup. 80 ml of the syrup will be taken when ce
Control group: 80 to 240 ml syrup (made by Yashil drug company, Aras) containing placebo of saffron and artificial sugar (Isonalt) in 240 ml syrup (identical in color, smell and taste with the saffron

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: aged 18 to 35 years; nulliparous; gestational age of 38 to 41 weeks; spontaneous onset of labor; singleton pregnancy with estimated fetal weight of 2500 to 4000 grams and cephalic presentation; no use of any herbal and anti anxiety drugs in the past 12 hours; reactive non stress test; body mass index of 19.8 to 30 kg/m²; having 8 years education or higher. Exclusion criteria: history of surgery on the uterus, cervix or vagina; allergy to saffron; known chronic diseases including hypertension, diabetes, diseases of the respiratory, cardiovascular, endocrine, etc.; history of mental illnesses; speech, hearing, visual or mental problems; known indications for caesarean section; premature rupture of membranes for more than 12 hours; any known fetal abnormalities; known fetal growth retardation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of labor pain. Timepoint: every one hour from about 3 cm cervical dilation to the end of the second stage of labor; one and 18 to 24 hours after delivery. Method of measurement: visual analogue scale (VAS) for pain.;Intensity of anxiety. Timepoint: at baseline, 3 to 4 hours after starting intervention, and 18 to 24 postpartum. Method of measurement: Spielberger state questionnaire and visual analogue scale for anexity.

Secondary

MeasureTime frame
Duration of first stage of labor (active phase). Timepoint: from 4 cm to 10 cm cervical dilatation. Method of measurement: Partogramm form.;Duration of second stage of labor. Timepoint: from 10 cm cervical dilation to delivery. Method of measurement: Partogramm form.;Duration of third stage of labor. Timepoint: immediately after birth to expultion of placenta and fetal membranes. Method of measurement: Partogramm form.;Hemoglobin. Timepoint: at baseline and 18 to 24 hours after birth. Method of measurement: labratory test.;Score of delivery experience. Timepoint: 18 to 24 hour after delivery. Method of measurement: delivery experience questionnaire.;Woman satisfaction rate. Timepoint: 18 to 24 hour after delivery. Method of measurement: one question with likert options.;Amount of oxytocin used. Timepoint: during the intervention. Method of measurement: observation.;Hematocrit. Timepoint: at baseline and 18 to 24 hours after birth. Method of measurement: labratory test.;Newborn bilirubin. Timepoint: 18 to 24 hours after delivery. Method of measurement: Billi Check device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoghayeh mohammadie rad

Nursing & Midwifery Faculty, Tabriz University of Medical Sciences

rmradobs@gmail.com+98 41 3479 6969

Outcome results

None listed

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