The Use of Iron Therapy for Patients With Anemia After Caesarean Section (VITAPOP)

March 31, 2022 updated by: Maastricht University Medical Center

The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial

The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Anemia after caesarean section is often treated with iron therapy to ensure that the hemoglobin will return to normal more rapidly. Scientific evidence for this action is limited. Several studies, in which iron therapy was given after orthopaedic or cardiac surgery, show that after 6 to 10 weeks the hemoglobin was not significantly different between patients treated with oral preparations and patients treated with a placebo. These studies have not examined the hemoglobin level during the first few weeks after surgery including the quality of life analysis.

The purpose of this double blind randomized controlled trial therefore is to examine the effect of both oral iron therapy and intravenous iron therapy on hemoglobin level and on the quality of life during the first few weeks postcaesarean in patients with a moderate anemia.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Maastricht University Medical Centre
      • Sittard, Limburg, Netherlands, 6162 BG
        • Orbis Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gynecological surgery
  • Hb 5-7 mmol/L

Exclusion Criteria:

  • Pregnancy
  • Oncological operations
  • Infections (PID)
  • Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies
  • Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization,
  • Small vulvar / vaginal operations such as (cysts, labia correction)
  • Endometrial ablation
  • Legal incapacity
  • The patient has used pre-operatively an iron preparation and / or blood transfusion or during the surgery
  • Hematologic disorders
  • Erythropoiesis-stimulating agents < 3months ago
  • Myelosuppressive therapy in history
  • Hepatitis
  • HIV
  • Alcohol abuses
  • Not understanding Dutch
  • Allergic reaction to iron therapy in past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ferinject
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Drug: Ferinject
Other Names:
  • intravenous iron
  • ferric carboxymaltose
Drug: Placebo for ferrous fumarate
Other Names:
  • Placebo tablets
Active Comparator: Ferrous fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Drug: Ferrous fumarate
Other Names:
  • Oral iron
  • Iron (II) fumarate
Drug: Placebo for ferinject
Other Names:
  • NaCl
Placebo Comparator: Placebo infusion and tablets
Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery
Drug: Placebo for ferrous fumarate
Other Names:
  • Placebo tablets
Drug: Placebo for ferinject
Other Names:
  • NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: 3 weeks postoperative
Serum hemoglobin level
3 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Ferritin
Time Frame: 3 weeks postoperative
Serum levels of ferritin
3 weeks postoperative
Serum Hepcidin
Time Frame: 3 weeks postoperative
Serum hepcidin level
3 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Vifor Pharma

Investigators

  • Principal Investigator: Roy Kruitwagen, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2015

Primary Completion (Actual)

May 17, 2018

Study Completion (Actual)

June 21, 2018

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 12-2-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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