The aim of this study is to determine the effect of Saffron oral tablet on cervical ripening in women with gestational age of 39-41 weeks. In this triple blind clinical trial, 50 eligible pregnant women will be allocated into two, Saffron or placebo, groups using block randomization stratified by parity with allocation ratio 1:1 and block sizes of 4 and 6 (determined with a computerized program). A person not involved in sampling and data collection will put the tablets into sequentially numbered sealed opaque envelopes to conceal allocation sequence. After collecting baseline characteristics and determining the Bishop score, every participant will get an envelope containing three 250 mg Saffron or placebo tablets and will be asked to take orally one pill every 8 hours. Subjects will be followed every 3-6 hours in terms of pain, bleeding, rupture of membranes and decreased fetal movements over phone for 24 hours. The subjects will refer to the hospital 10-12 h and 20-24 h after the starting to take the pills and also when occurring any of the events and the Bishop score and other outcomes will be examined. Non-stress test will be done at 24 hours after starting the intervention for any subject not admitted for delivery in this period. If it was reactive, she will leave the hospital and will be followed up in terms of outcomes of interest. Data will be analyzed using independent sample T-test, ANCOVA and chi-square tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212233706N19
Registration date:2013-03-17, 1391/12/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-17, 1391/12/27
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-03-27, 1392/01/07
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Crocus Sativus (Saffron) tablet on cervical ripening in term pregnant women: a randomized controlled trial
Public title
The effect of oral Crocus Sativus (Saffron) tablet on cervical ripening in pregnant women with gestational age of 39-41 weeks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Women with 1-3 gravidity and gestational age of 39-41 weeks 2. Not starting uterine contractions 3. Willing to deliver in Bonab hospital 4. Secondary and higher educational level 5. Bishop score of four or less 6. Singleton pregnancy 7. Cephalic presentation 8. Intact amniotic sac 9. Reactive non-stress test 10. Estimated fetal weight of 2500 to 4000 grams by ultrasound or examination.
Exclusion criteria: 1. History of cryotherapy or cautery of the cervix 2. History of cesarean or having any indication for cesarean section in current pregnancy 3. Diagnosed fetal anomalies 4. Cephalo-Pelvic Disproportion 5. Any known placental problem (placenta previa, placental abruption, placental insufficiency) 6. Maternal infection and systemic chronic diseases, including respiratory diseases, cardio - vascular, endocrine and... 7. Using any of the following drugs by the woman (oral hypoglycemic agents and insulin, anticoagulants such as aspirin and Warfarin ,non steroidal -anti-inflammatory drugs such as ibuprofen and naproxen, herbal drugs and antihypertensives, benzodiazepines such as lorazepam and diazepam, barbiturates such as phenobarbital, narcotics, antidepressant, Alcohol) 8. Not access to telephone line
Age
From 18 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research deputy, Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2013-02-18, 1391/11/30
Ethics committee reference number
91219
Health conditions studied
1
Description of health condition studied
Cervical ripening
ICD-10 code
O62.0
ICD-10 code description
Primary inadequate contractions
Primary outcomes
1
Description
Bishop score
Timepoint
Befor intervention, at the time of onset of uterin contractions, 10-12 and 20-24 hours after intervention or at the time of doing other treatment interventions
Method of measurement
The Bishop rating system
Secondary outcomes
1
Description
Duration of the first stage of labor
Timepoint
After finishing the first stage of labor
Method of measurement
Patient record
2
Description
Interval of onset of uterine active contractions and starting intervention
Timepoint
In the 24 hours after starting intervention
Method of measurement
Patient and clinician report
3
Description
Duration of the second stage of labor (in minutes)
Timepoint
After finishing the second stage of labor
Method of measurement
Observation and physical exam
4
Description
Need to induce labor
Timepoint
Between admission in delivery room and delivery
Method of measurement
According to hospital records
5
Description
Delivery type
Timepoint
After delivery
Method of measurement
According to hospital records
6
Description
Vaginal delivery in 24 hours after starting intervention
Timepoint
24 hours after intervention
Method of measurement
According to hospital records
7
Description
Amount of hemorrhage
Timepoint
The time of admission in delivery room and 12 hours after delivery
Method of measurement
Hematocrit assessment
Intervention groups
1
Description
Intervention group: Receiving 3 doses of oral 250 mg saffron tablets each 8 hours
Category
Treatment - Drugs
2
Description
Control group: Receiving 3 doses of oral 250 mg placebo tablets each 8 hours
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Sadi Roghaieh
Street address
Zavaraq road, opposite of Imam-e-Asr seminary
City
Bonab
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz university of medical sciences
Full name of responsible person
Dr. Kazem Shakouri
Street address
Golgasht st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sadi Roghaieh
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1233 0190
Fax
Email
r.sadi65@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh Charandabi
Position
Assistant professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
alizades@tbzmed.ac.ir smoalch@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh Charandabi
Position
Assistant professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
Email
alizades@tbzmed.ac.ir smoalch@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)