The aim of this study was determine the effect of consumption of date fruit on the amount and duration of the postpartum bleeding done on 100 women in Omolbanin hospital Mashhad. This study is a phase 2 clinical trial. Inclusion criteria: singleton pregnancy; vertex presentation; vaginal delivery without the use of Vacuum and forceps; lack of laceration of fetus membranes before 12 hours ;no history for medical diseases and side-effects of pregnancy and breastfeeding less than one hour after delivery. Exclusion criteria: mother quit the participation in the study; consuming less than 50 g dates daily; no completion the Pictorial form; intense postpartum bleeding that needs medicine to be cured. This study lasted from july, 11,201 5 to October, 11, 2015. 2 hours after the delivery, the mother was given 100 gr dates that she was supposed to eat in two hours and she was asked to eat 10 dates daily with her breakfast and also to each mother was given 3 pads of tampon and she was asked to tick the form after each daily changing. The control group was given only 3 pads of tampon. Finally the amount and duration of bleeding in two groups were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503116807N16
Registration date:2015-12-05, 1394/09/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-05, 1394/09/14
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-07-02, 1394/04/11
Expected recruitment end date
2015-10-03, 1394/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dates fruit on the amount and duration of postpartum hemorrhage
Public title
Dates effect on bleeding
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age: 18-35 years old; mother must at least have elementary education; mother is inhabited in Mashhad; BMI: 20-29;no history for medical diseases and side-effects of pregnancy; weight of the fetus: 2500-4000; term pregnancy (gestational age 37 to 42 weeks); singleton pregnancy; breastfeeding less than one hour after delivery; vertex presentation; normal amniotic fluid volume; lack of laceration of fetus membranes before 12 hours; vaginal delivery without using vacuum or forceps; lack of intense post partum bleeding after the delivery. Exclusion criteria: mother quit the participating in the study; admittance to a hospital for the mother or the infant after the delivery; consuming less than 50 g dates daily; no completion the Pictorial form; intense bleeding that needs medicine to be cured.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee of Shahid Beheshti University of Medical Science
Street address
Shahid Beheshti University of Medical Sciences،Velenjak St، Shahid Chamran Highway، Tehran، Iran
City
Tehran
Postal code
1985717443
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
SBMU.REC.1394.47
Health conditions studied
1
Description of health condition studied
postpartum bleeding
ICD-10 code
O72.2
ICD-10 code description
Delayed and secondary postpartum haemorrhage
Primary outcomes
1
Description
a mount of bleeding
Timepoint
10 days after delivery
Method of measurement
Pictorial form
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: the mother should eat 100 g dates during her breakfast and at most in 2 hours for 10 days and also to each mother was given 3 pads of tampon to use and then tick it in the pictorial form.
Category
Prevention
2
Description
The control group of was just given 3 pads of tampon and the Pictorial form.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Zahra Yadegari
Street address
No 6, Tehran Ave، Imam Reza Street، Mashhad، Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mrs Mahrokh Dolatian
Street address
Shahid Beheshti University of Medical Sciences،Velenjak St، Shahid Chamran Highway، Tehran، Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of 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
Mrs Sedigheh Amir Ali Akbari
Position
Academic Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery، Shahid Beheshti University of Medical Sciences، Valiasr Ave
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
asa_akbari@yahoo.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
Mrs Sedigheh Amir Ali Akbari
Position
Academic Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery، Shahid Beheshti University of Medical Sciences، Valiasr Ave
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
asa_akbari@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)