NCT07340450

Brief Summary

Postpartum anemia is a common condition associated with adverse maternal outcomes. This study aimed to compare the effectiveness of oral iron therapy versus intravenous iron therapy in women with postpartum anemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Postpartum Anaemia

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin level

    Baseline to 6 weeks postpartum

Study Arms (2)

Group A: Intravenous Iron Therapy

EXPERIMENTAL

Participants received intravenous iron therapy for the treatment of postpartum anemia

Drug: Ferric Carboxy Maltose

Group B: Oral Iron Therapy

EXPERIMENTAL

Participants received oral iron therapy for the treatment of postpartum anemia.

Drug: Ferrous Sulfate

Interventions

Ferric Carboxy MaltoseDRUG

Participants received Intravenous iron i.e ferric carboxymaltose (≤1,000 mg) were given to patients in Group "A" either as a single dose or as two doses spaced three days apart in 100 milliliters of 0.9% normal saline during a half-hour period.

Group A: Intravenous Iron Therapy
Ferrous SulfateDRUG

Participants given tablet Ferrous sulfate, 325 mg orally three times a day.

Group B: Oral Iron Therapy

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All women with postpartum anaemia as per operational definition i.e Haemoglobin \<11 g/dl at 24 hours after delivery (either caesarean or SVD).
  • Age 20-40 years.
  • BMI 19-25.
  • Pre-operative haemoglobin \>10 g/dl.
  • Both primiparous and multiparous.
  • Both primigravida and multigravida.

You may not qualify if:

  • Iron Intolerance or previous history of allergy to iron
  • Parenteral Iron hypersensitivity
  • Patients with thalassemia
  • Indication of blood transfusion
  • Patients with bleeding/ clotting disorders
  • Patients with postpartum haemorrhage
  • Patients with chronic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahida Islam Medical College and Hospital, Lodhran

Lodhrān, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

ferrous sulfate

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PGR obstetrics and Gynaecology

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

February 18, 2025

Primary Completion

August 18, 2025

Study Completion

August 18, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

PA(1)