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

Primary Purpose

Postoperative Anaemia

Status

Terminated

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Ferinject

Ferrous fumarate

Placebo for ferrous fumarate

Placebo for ferinject

About this trial

This is an interventional treatment trial for Postoperative Anaemia focused on measuring postoperative, anemia, gynaecologic, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Maastricht University Medical Centre
Orbis Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ferinject

Ferrous fumarate

Placebo infusion and tablets

Arm Description

Once an infusion of Ferinject 1000 mg, 1 day after surgery

2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery

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

Outcomes

Primary Outcome Measures

Hemoglobin

Serum hemoglobin level

Secondary Outcome Measures

Serum Ferritin

Serum levels of ferritin

Serum Hepcidin

Serum hepcidin level

Full Information

NCT ID

NCT01975272

First Posted

September 30, 2013

Last Updated

March 31, 2022

Sponsor

Maastricht University Medical Center

Collaborators

Vifor Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01975272

Brief Title

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

Acronym

VITAPOP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Disapointing randomization rate

Study Start Date

March 2, 2015 (Actual)

Primary Completion Date

May 17, 2018 (Actual)

Study Completion Date

June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

Collaborators

Vifor Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Anaemia

Keywords

postoperative, anemia, gynaecologic, surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ferinject

Arm Type

Active Comparator

Arm Description

Once an infusion of Ferinject 1000 mg, 1 day after surgery

Arm Title

Ferrous fumarate

Arm Type

Active Comparator

Arm Description

2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery

Arm Title

Placebo infusion and tablets

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ferinject

Other Intervention Name(s)

intravenous iron, ferric carboxymaltose

Intervention Type

Drug

Intervention Name(s)

Ferrous fumarate

Other Intervention Name(s)

Oral iron, Iron (II) fumarate

Intervention Type

Drug

Intervention Name(s)

Placebo for ferrous fumarate

Other Intervention Name(s)

Placebo tablets

Intervention Type

Drug

Intervention Name(s)

Placebo for ferinject

Other Intervention Name(s)

NaCl

Primary Outcome Measure Information:

Title

Hemoglobin

Description

Serum hemoglobin level

Time Frame

3 weeks postoperative

Secondary Outcome Measure Information:

Title

Serum Ferritin

Description

Serum levels of ferritin

Time Frame

3 weeks postoperative

Title

Serum Hepcidin

Description

Serum hepcidin level

Time Frame

3 weeks postoperative

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roy Kruitwagen

Organizational Affiliation

Maastricht University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Centre

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6202 AZ

Country

Netherlands

Facility Name

Orbis Medical Centre

City

Sittard

State/Province

Limburg

ZIP/Postal Code

6162 BG

Country

Netherlands

12. IPD Sharing Statement

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

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