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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 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)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231023059817N4
Enrollment
170
Registered
2024-08-16
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Anemia. Anemia of the puerperium

Interventions

Intervention 1: 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

Sponsors

Zistaroo Danesh Company
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Mothers who have hemoglobin between 9 and 10.5 g/dl after giving birth. Having informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.;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.;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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSedigheh Hantoushzadeh

Tehran University of Medical Sciences

hantoushzadeh@tums.ac.ir+98 21 6658 1616

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026