Efficacy of Treatment of Postpartum Anaemia With Intravenous Iron Versus Oral Iron in a Tertiary Hospital in South East, Nigeria.

NCT07110935 | Completed Phase 1

• 1 other identifier: FMC/QEH/G.596/Vol.10/266
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

Background:Anaemia is a condition of public health importance.Iron deficiency anaemia is the most common cause of anaemia in pregnancy.Postpartum anaemia poses a significant role for postpartum morbidity and mortality and should be treated.Postpartum iron deficiency anaemia warrants greater attention and higher quality of care.Oral iron treatment has been considered the standard of care. However,parenteral iron treatment is expected to be advantageous in cases where oral iron therapy is not possible.As a result,there is increased interest in parenteral iron therapy. Objectives:To determine the effect of treatment of postpartum anaemia with intravenous versus oral iron therapy at Federal Medical Centre,Umuahia. Materials and Method:This study is a prospective randomized controlled study carried out in department of Obstetric and Gynaecology, Federal Medical Centre,Umuahia,the capital of Abia State,South-east, Nigeria. The study population comprised of postpartum women with mild to moderate anaemia within 48 hours of delivery who were randomized into two groups.One group will be given oral iron therapy and the other intravenous iron dextran.Response and comparative effects of treatment using either route of administration were assessed at 6 weeks postpartum.The biodata,obstetric characteristics and haemoglobin estimation of the respondents were recorded on a structured study proforma.The data obtained from the study was analyzed with the statistical package for the social sciences(SPSS) software.Continuous variables obtained from this study were expressed as mean and standard deviation while categorical variables were summarized using frequency and percentages.Association between categorical variables were done using chi square.P-value less than 0.05 was taken as significant.

Conditions

Postpartum Anaemia

Outcome Measures

Primary Outcomes (2)

• Mean postpartum haematocrit

  Six weeks

• Mean hematocrit following treatment with iron dextran

  Six weeks

Secondary Outcomes (1)

• Incidence and patterns of postpartum anaemia

  Six weeks

Study Arms (2)

One hundred and forty five women who picked "i" were assigned intravenous iron therapy group

EXPERIMENTAL

Drug: intravenous iron

One hundred and forty five women who picked "o" were assigned oral iron therapy group

ACTIVE COMPARATOR

Drug: oral iron

Interventions

intravenous iron DRUG

intravenous iron dextran

One hundred and forty five women who picked "i" were assigned intravenous iron therapy group

oral iron DRUG

oral iron(ferrous Sulphate)

One hundred and forty five women who picked "o" were assigned oral iron therapy group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who have vaginal delivery of singleton baby and are seen within 48hours of childbirth
• Women with mild and moderate anaemia
• Women who gave their consent to participate in the study.

You may not qualify if:

• Women with severe anaemia
• Women with multiple pregnancy
• Women with genotype HbSS
• Women with HIV infection
• Women who delivered by caesarean section
• Women with co-morbidity like hypertensive disorders, renal pathology
• Women who decline consent after adequate counseling.
• Previous and current history of adverse reaction to iron dextran

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (1)

Federal Medical Centre , Umuahia

Umuahia, Abia State, 440102, Nigeria

Location

MeSH Terms

Interventions

Iron

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Assumpta Nnenna Nweke

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 8, 2025
• Study Start: September 13, 2018
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)