The aim of this study is to determine the effect of date fruit consumption on amount of postpartum hemorrhage.
Design
Clinical trial with a control and randomized parallel group design without blinding, will be performed on 98 people.Randomization list from the online randomization service Sealed Envelope Ltd. 2019 will be used.
Settings and conduct
This study will be performed in the labour and postpartum ward of Al-Zahrah Educational, Research and Remedial Center in Rasht, affiliated to Guilan University of Medical Sciences. Intervention, consume 100 gr of dates will be performed on the intervention group. There is no intervention in the control group. Both groups will receive routine postpartum care. This study is not blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 and 35 years; BMI between 18/5 to 29/9 kg/m2; no existence and history of medical disorders and pregnancy complications; estimated fetal weight between 2500 to 4500 gr; term and singleton pregnancy; normal amniotic fluid index. Exclusion criteria: rupture of embryonic membranes more than 12 hours; precipitous delivery; operative delivery; grade 3 or 4 tear; retention of placenta; severe bleeding in fourth stage of birth; receive oxytocin more than routine dosage of hospital.
Intervention groups
Intervention group: Two hours after delivery and stability of the samples 100 gr of Bam mazafati dates which are weighed and packaged by the researcher, should be given to them to eat within a maximum time of 2 hours. A pack of sanitary pads and Pictorial Blood loss Assessment Chart (PBAC) will be given to them. PBAC should be completed within first 24 hours after delivery based on amount of bleeding. Control group: In this group, only routine care will be performed. Also a package of sanitary pads and PBAC will be given to them.
Main outcome variables
Amount of postpartum hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210607051505N2
Registration date:2021-10-31, 1400/08/09
Registration timing:prospective
Last update:2021-10-31, 1400/08/09
Update count:0
Registration date
2021-10-31, 1400/08/09
Registrant information
Name
maryam niknami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
niknami@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-04-09, 1401/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the effect of date fruit consumption on amount of postpartum hemorrhage in women hospitalized.
Public title
Survey of the effect of date fruit consumption on amount of postpartum hemorrhage.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 35 years
Having minimum of primary education
History of childbirth less than 5 times ( not being grandmultipara)
Body Mass Index (BMI) between 18/5 to 29/9 kg/m2
Lack of history and absence of medical disorders and pregnancy complications
Not receiving herbal remedies during pregnancy
Estimated fetal weight between 2500 to 4500 gr
Term and singleton pregnancy
Vertex presentation
Normal amniotic fluid index in third trimester sonography
Normal length of the first, second and third stages based on birth partograph
Breastfeeding begins less than two hours after delivery
Exclusion criteria:
Rupture of embryonic membranes more than 12 hours
Precipitous delivery
Operative delivery
Grade 3 or 4 tear
Retention of placenta
Remove placenta with courage
Severe bleeding in fourth stage of birth
Receive oxytocin more than routine dosage of hospital
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:
98
Randomization (investigator's opinion)
Randomized
Randomization description
The type of randomization is blocking and will be divided into two groups of date consumer and control using the block randomization method with the size of 4 and 6 blocks. The method used to generate the random allocation sequence is from the online randomization service Sealed Envelope Ltd. 2019 will be used (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
The method of concealing the allocation is to use sealed envelopes.
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 Guilan University of Medical Sciences
Street address
Daneshjoo St, Rasht - Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.GUMS.REC.1400.309
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
O72.1
ICD-10 code description
Other immediate postpartum haemorrhage
Primary outcomes
1
Description
Postpartum hemorrhage scores within first 24 hours ( primary Postpartum hemorrhage) in pictorial blood loss assessment chart
Timepoint
First 24 hours after intervention
Method of measurement
The method of measuring the Postpartum hemorrhage is the standard pictorial blood loss assessment chart. This tool is a table that shows the days of bleeding in horizontal and bloodstain pads or tampons or clots in vertical rows. Bloody pads or tampons divide to three degrees: mild with 1 score, moderate with 5 score and severe with 20 score. Small and large clots gain 1 and 5 scores, respectively. Women mark table after changing their pads every time within 24 hours after birth. At the end of 24 hours the final scores will be calculated. The cut-off score of severe bleeding is 100 and more. The validity and reliability of PBAC have been proven in numerous studies.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two hours after delivery and stability of the samples 100 gr of Bam Mazafati dates which are weighed and packaged by the researcher, should be given to them to eat within a maximum time of 2 hours. A pack of sanitary pads will be given. Pictorial Blood loss Assessment Chart (PBAC) will be given to them and it should be completed within first 24 hours after delivery based on amount of bleeding.
Category
Prevention
2
Description
Control group: In this group, only routine care will be performed. Also a package of sanitary pads and PBAC will be given to them
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational,Research and, Remedial Center
Full name of responsible person
Maryam Niknamy
Street address
Namjoo St, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5058
Email
niknami@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Guilan University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Daneshjoo St, Rasht - Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5058
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Farash
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Daneshjoo St., Rasht - Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5058
Email
farimah.farash98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Niknami
Position
Faculty Member (Instructor)
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Daneshjoo St., Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5058
Email
niknami@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Farash
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Daneshjoo St., Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5058
Email
farimah.farash98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available