This is a randomized clinical trial study, to determine the effect of consumption date fruit on cervical ripening and outcome of labor in nulliparous women. Study participants are 110primigravida pregnant women 18 to 45 years old with gestational age of 38، Bishop score of four or less and low risk pregnancy. Study participants were chosen In referring to Amir almomenin hospital and Clinic doctor in semnan and they were put in two group. 1. in Group of date fruit, 7 fresh and ripe date fruit without cores in daily Consume from 38 weeks gestation until onset of labor and at the time of hospitalization 2. Control group(routine care) . About,A few days after inervention, 1week after intervention, 2weeks after ,3weeks after that and at the time of hospitalization the elements were checked from cervical ripening and labour point of view. Women With rupture of membranes, high risk pregnancy and non-cephalic presentation are excluded. Finally, results will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207214529N11
Registration date:2013-08-04, 1392/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Nourossadat Kariman
Name of organization / entity
Shaheed Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 3133
Email address
n_kariman@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-08-05, 1391/05/15
Expected recruitment end date
2013-07-01, 1392/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of consumption date fruit's effect on cervical ripening and outcome of labor in nulliparous women
Public title
effect of consumption date fruit on cervical ripening
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Singleton pregnancy ;Gestational age from38 weeks ;Bishop score of four or less; Not taking herbal or chemical drugs, Not having sexual intercourse and vaginal exam, 24 hours before and up to end of the study ؛ Not having consumption of date fruit, 7 days before of the study؛live in Semnan city .
Exclusion criteria: noncephalic presentation;non Reactive non-stress test; An estimated weight of over 4000 grams;High risk pregnancy ;Diagnosed fetal anomalies ; Cephalo-Pelvic Disproportion; Abnormal vaginal bleeding ; Any known placental problem (placenta previa, placental abruption, placental insufficiency; Maternal infection and systemic chronic diseases ;Taking chemical/ herbal drugs in study time table ; Having sexual intercourse in study time table ; rupture of fetal membranes ;consumption of date fruit in control group
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Next to Taleghani hospital, Evin, Shahid Chamran Highway, Tehran, Iran
City
tehran
Postal code
-
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
122
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
cervical ripening
Timepoint
Before intervention, A few days,1 week,2 weeks ,3 weeks after intervation and at the time of hospitalization
Method of measurement
Examination
Secondary outcomes
1
Description
Delivery type
Timepoint
After delivery
Method of measurement
According to hospital records
2
Description
Using of oxytocin
Timepoint
Between admission in delivery room and delivery
Method of measurement
According to hospital records
3
Description
Duration of the first stage of labor (in minutes)
Timepoint
After finishing the first stage of labor
Method of measurement
Patient record
4
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
5
Description
Neonatal Apgar
Timepoint
at last of study
Method of measurement
According to hospital records
6
Description
Duration of the third stage of labor (in minutes)
Timepoint
After delivery of fetus
Method of measurement
According to hospital records
7
Description
status of Amniotic fluid
Timepoint
at last of study
Method of measurement
Observation and physical exam
Intervention groups
1
Description
in Group of date fruit , consumption 7 fresh and ripe date fruit without cores in daily from 38 weeks gestation until onset of labor and at the time of hospitalization
Category
Prevention
2
Description
Control group: routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir ALMOMENIN Educational Center and Clinic of Doctor
Full name of responsible person
Maryam Yousefy Jadidi
Street address
Semnan - Amir ALMOMENIN Hospital Educational Center , unit labor
City
semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Simbar
Street address
Deputy of Research, School of Nursing and Midwifery
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Yousefy Jadidi
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery
City
Tehran
Postal code
-
Phone
00
Fax
00
Email
maryam.usefii@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nourossadat kariman
Position
Master of Midwifery
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery
City
Tehran
Postal code
-
Phone
+98 21 8820 2512
Fax
-
Email
n_kariman@sbmu.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Yousefy Jadidi
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery
City
Semnan
Postal code
4817983547
Phone
+98 937 934 4375
Fax
-
Email
maryam.usefii@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)