This study is a clinical trial to determine the The effect of late pregnancy consumption of date fruit on onset of labor in nulliparous women. The sample consisted of Iranian women 35-18 years of age with term pregnancy, without history of infertility, singleton pregnancy who have a BMI in the normal range, and without any chronic illnesses or antenatal complications (low-risk pregnancies) in
the current pregnancy. The first group of women were given a supply of date fruit and instructed to take 70-75 gr per day until the onset of labour pains.The second group of women were not given date fruit and were asked to abstain from consuming date fruits for the period of the study, but were otherwise monitored and given the same care as the first group. If delivery to 40 weeks does not start, both groups will be asked for birth control and testing to assess fetal well being. If you do not start until 41 weeks birth, the mother is referred for termination of pregnancy to delivery. At the end of the study,onset of labor in the two groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304072956N4
Registration date:2013-06-28, 1392/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-28, 1392/04/07
Registrant information
Name
Masoumeh Kordi
Name of organization / entity
Nursing and Midwifery Schoo, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
kordim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2013-09-30, 1392/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of late pregnancy consumption of date fruit on onset of labor in nulliparous women
Public title
The effect of late pregnancy consumption of date fruit on onset of labor
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Iranian women who is living in Mashhad city; nulliparus or primiparous women; age 18 to 35 years old; pregnant women between 37-38 weeks; singleton pregnancy; BMI in the normal range; low-risk pregnancies.
Exclusion criteria: elective caesarean section; consumptin of dates cause acne or rashes or allergic symptoms; use of traditional, herbal medicines or other methods to facilitate delivery; smoking, alcohol consumption and substance abuse and induction of labor before 41 weeks.
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:
210
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
Mashhad Universityof Medical Sciences
Street address
Nersing and Midwifery School, Doktora crossroad
City
Mashhad
Postal code
9137913316
Approval date
2013-02-06, 1391/11/18
Ethics committee reference number
511/4303
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z37.0
ICD-10 code description
Single live birth
Primary outcomes
1
Description
Onset of labor
Timepoint
3- 4 weeks after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Side effects
Timepoint
3-4 weeks after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
After explanation and enrolment in the study, women were asked to participate in one of two groups.The first group of women were given a supply of date fruit and instructed to take 70-75gr per day until the onset of labour pains, and to keep a note of their intake. Mothers monitor weekly. If labor does not start until 40 weeks, mothers are asked refer to hospital to do tests for assessment of fetal well being. If there is no problem mothers control up to 41 weeks. If no onset of labor until 41 weeks of pregnancy terminat. Finally, the onset of labor in the two groups are compared
Category
Other
2
Description
The second group of women were
not given date fruit and were asked to abstain from consuming date fruits for the period of the study, but were otherwise
monitored and given the same care as the first group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omolbanin hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad Universityof Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad, Vakil Abad Boulevard, University College, School of Pharmacy, Department of Pharmaceutics
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad Universityof 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
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Kordi
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctors Crossroads
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
kordim@mums.ac.ir; aghaeimf901@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Kordi
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctors Crossroads
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
kordim@mums.ac.iraghaeimf901@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Univesity of Medical Sciences
Full name of responsible person
Fatemeh Aghaei Meybodi
Position
Midwife
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctors Crossroads
City
Mashhad
Postal code
Phone
Fax
Email
aghaeimf901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)