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Completed

NCT Number: NCT07110935

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

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.

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Key information

Conditions

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Federal Medical Centre , Umuahia

Umuahia, Abia State, 440102, Nigeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous iron

Drug

intravenous iron dextran

oral iron

Drug

oral iron(ferrous Sulphate)

Primary outcomes

  1. Mean postpartum haematocrit

    Time frame: Six weeks

  2. Mean hematocrit following treatment with iron dextran

    Time frame: Six weeks

Secondary outcomes

  1. Incidence and patterns of postpartum anaemia

    Time frame: Six weeks

Sponsors and collaborators

Lead sponsor

Federal Teaching Hospital Abakaliki

Other Gov

Registry information

Official study title

Efficacy of Treatment of Postpartum Anaemia With Intravenous Iron Versus Oral Iron

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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