Comparing the therapeutic effects of two methods of injectable iron and oral iron on quality of life, sleep quality, and breastfeeding self-efficacy in women with iron deficiency/ iron deficiency anemia in the postpartum period (postpartum)
Comparing the treatment results of two methods of injectable iron (case) and oral iron (control) in iron deficiency/iron in postpartum anemia, quality of life, sleep quality, and breastfeeding self-efficacy in six weeks
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 170 patients. Randomization will be done with a ratio of 1:1 and using two-allele blocks of size 4.
We specify the sequence through the following sites:
Sealedenvelope.com/simple-randomizer/v۱/lists
Settings and conduct
It is a randomized and double-blind clinical trial (at the level of outcome evaluator and statistician) to determine the therapeutic results of two methods of injectable iron and oral iron in post-partum anemia. It takes place within six weeks of childbirth with a non-inferiority approach.
place: Amirul Mominin Hospital in Zabul city
Participants/Inclusion and exclusion criteria
Mothers who have hemoglobin between 9 and 10.5 g/dl in blood test on the same day after giving birth.
Intervention groups
Treatment group:
After determining the basic hemoglobin number, the calculated total injected iron dose is given to the patients. To inject 1000 mg of iron (two ampoules of 500 mg), dilution is first done with 250 ml of normal saline and injected for 15 minutes.
control group:
For the patients who received oral iron in the form of ferrous sulfate, ferrous sulfate will be prescribed in the form of 50 mg elemental iron tablets with instructions to take three oral tablets daily with a glass of water, 1 hour before meals from day 0 to day 42. And patients will be taught how to use it. Used blister packs of pills will be returned to assess adherence to prescribed therapy.
Main outcome variables
An increase in hemoglobin after treatment of 2 g/dL or more.
Changing the quality of life
Change in sleep quality
Changing the breastfeeding self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231023059817N4
Registration date:2024-08-16, 1403/05/26
Registration timing:prospective
Last update:2024-08-16, 1403/05/26
Update count:0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
Mohammad Haddadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2253 9892
Email address
mohammadhaddadi1997@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic effects of two methods of injectable iron and oral iron on quality of life, sleep quality, and breastfeeding self-efficacy in women with iron deficiency/ iron deficiency anemia in the postpartum period (postpartum)
Public title
Comparing the therapeutic effects of two methods of injectable iron and oral iron on quality of life, sleep quality and breastfeeding self-efficacy in women with iron deficiency/ iron deficiency anemia in the postpartum period (postpartum)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who have hemoglobin between 9 and 10.5 g/dl after giving birth.
Having informed consent
Exclusion criteria:
History of anemia due to reasons other than iron deficiency and blood loss during pregnancy or being pregnant
The presence of more bleeding than usual postpartum (after the first 24 hours, more than menses or passing a large clot)
Severe active infection
Having a history of allergy to injectable iron
The presence of systemic disease in the mother (patients who received erythropoiesis stimulator (erythropoietin) during the last 3 months, patients who received myelosuppressive treatment and blood or blood products during delivery, patients with asthma under treatment, patients with hepatitis, Patients with HIV, patients with blood problems other than iron deficiency, patients with IBD, patients with CKD (eGFR<60)
Having a history of sleep disorder or depression and mothers who need to receive antidepressants.
Mothers who have suffered the death of a fetus or baby
Taking PPI, H2 blocker and antihistamine
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is a method in which samples are taken randomly from a population. In this method, the samples are first divided into smaller blocks, and then, using a random process, the samples are divided into different groups within each block. Allocating patients into intervention and control groups will be done randomly with a ratio of 1:1 and using two-allele blocks of size 4. We specify the sequence through the following sites:
Sealedenvelope.com/simple-randomizer/v۱/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the outcome assessor and the data analyst are kept blind. Participants do not know which group they are in. The analyst analyzes the data after coding the patients by the operator and does not know which code is related to the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex - Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.145
Health conditions studied
1
Description of health condition studied
Postpartum Anemia
ICD-10 code
O90.81
ICD-10 code description
Anemia of the puerperium
Primary outcomes
1
Description
An increase in hemoglobin after treatment of 2 g/dL or more
Timepoint
1. Which was taken within 12 hours or more from the time of delivery. 2. Referred on the 42nd day of the intervention
Method of measurement
Laboratory
2
Description
Sleep quality
Timepoint
1. Which was taken within 12 hours or more from the time of delivery. 2. Referred on the 42nd day of the intervention
Method of measurement
PSQS sleep quality questionnaire. This 14-question questionnaire examines the person's opinion about the quality of sleep during the last 2 weeks. In the PSQS sleep quality questionnaire, the questions of this questionnaire measure numerical and subjective data with a Likert scale
3
Description
Quality of Life
Timepoint
1. Which was taken within 12 hours or more from the time of delivery. 2. Referred on the 42nd day of the intervention
Method of measurement
MPQOLI postpartum quality of life questionnaire, this tool contains 16 items. Grading is done with a five-point Likert scale (5) very high, (4) high, (3) moderate, (2) low, (1) very low/not at all.
4
Description
Breastfeeding self-efficacy
Timepoint
Breastfeeding Self-Efficacy
Method of measurement
Breastfeeding Self-Efficacy Short Scale BSES-SF: The Short Breastfeeding Self-Efficacy Questionnaire of Dennis (2003) includes 13 questions. All questions started with the prefix "I can always" which are designed as positive sentences in a 5-point Likert scale and according to Bandura's suggestion in self-efficacy theory.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After determining the basic hemoglobin number, the calculated total injected iron dose is given to the patients. In order to inject 1000 mg of iron (two ampoules of 500 mg), dilution is first done with 250 ml of normal saline and it will be injected during 15 minutes. Before starting treatment, patients will complete questionnaires related to quality of life, sleep quality, and breastfeeding. The patients returned on the 42nd day after the intervention and the necessary tests were taken from them and the related questionnaires will be completed again.
Category
Treatment - Drugs
2
Description
Control group: For patients who were in the group receiving oral iron in the form of ferrous sulfate, ferrous sulfate in the form of 50 mg elemental iron tablets with instructions to take three oral tablets per 8 hours (18) with a glass of water, 1 hour before meals from day 0 to day 42. It will be prescribed and the patients will be taught how to use it. Used blister packs of pills will be returned to assess adherence to prescribed therapy. Before starting the treatment, patients in the control group will also complete questionnaires related to quality of life, sleep quality, and breastfeeding. The patients returned on the 42nd day after the intervention and the necessary tests were taken from them and the related questionnaires will be completed again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AMIR AL-MOMENIN HOSPITAL
Full name of responsible person
زهرا شهرکی
Street address
Kilometer 3 Zabol Road - Zahedan, Amir Al-Momenin Ali Hospital
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
1811694784
Phone
+98 54 3229 5115
Email
amirhospital@zbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zistaroo Danesh Company
Full name of responsible person
Shirin Mirzazadeh
Street address
Unit 404, 4th Floor, Rose-mall Building, Hemmet Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۹۸۷۱۱۷۱۲
Phone
+98 26 3476 2108
Email
info@zistdaru.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zistaroo Danesh Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedigheh Hantoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
ali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
hantoushzadeh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedigheh Hantoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
ali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
hantoushzadeh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Haddadi
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
Reproductive Health
Street address
ali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9320
Email
mohammadhaddadi1997@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the study data will be given to the company in the form of articles and reports, and the data will be provided anonymously if needed and requested by the company manager or the editor of the article.
When the data will become available and for how long
The access period starts 6 months after the results are printed, only by the editor of the article anonymously or the company responsible
To whom data/document is available
Principal investigator Statistical analyzer Article editor-in-chief Responsible for the company
Under which criteria data/document could be used
Editor of the article to check the authenticity of the data The company responsible for use in industry
From where data/document is obtainable
Request by official email from the research officer
What processes are involved for a request to access data/document
First, a clear request should be given by official email, the reason for the data request should be stated and the work to be done to the end.