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

NCT ID: NCT07110935

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-13
• Study Completion Date: 2019-02-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

intravenous iron

Intervention Type: DRUG

intravenous iron dextran

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

Group Type: ACTIVE_COMPARATOR

oral iron

Intervention Type: DRUG

oral iron(ferrous Sulphate)

Interventions

intravenous iron

intravenous iron dextran

Intervention Type: DRUG

oral iron

oral iron(ferrous Sulphate)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal Teaching Hospital Abakaliki

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assumpta Nnenna Nweke

Dr Assumpta Nnenna Nweke

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal Medical Centre , Umuahia

Umuahia, Abia State, Nigeria

Countries

Nigeria

Other Identifiers

FMC/QEH/G.596/Vol.10/266

Identifier Type: -

Identifier Source: org_study_id