NCT01975272

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 22, 2022

Completed
Last Updated

August 22, 2022

Status Verified

March 1, 2022

Enrollment Period

3.2 years

First QC Date

September 30, 2013

Results QC Date

January 27, 2022

Last Update Submit

March 31, 2022

Conditions

Postoperative Anaemia

Keywords

postoperativeanemiagynaecologicsurgery

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin

    Serum hemoglobin level

    3 weeks postoperative

Secondary Outcomes (2)

  • Serum Ferritin

    3 weeks postoperative

  • Serum Hepcidin

    3 weeks postoperative

Study Arms (3)

Ferinject

ACTIVE COMPARATOR

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

Drug: FerinjectDrug: Placebo for ferrous fumarate

Ferrous fumarate

ACTIVE COMPARATOR

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

Drug: Ferrous fumarateDrug: Placebo for ferinject

Placebo infusion and tablets

PLACEBO COMPARATOR

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 fumarateDrug: Placebo for ferinject

Interventions

FerinjectDRUG
Also known as: intravenous iron, ferric carboxymaltose
Ferinject
Ferrous fumarateDRUG
Also known as: Oral iron, Iron (II) fumarate
Ferrous fumarate
Placebo for ferrous fumarateDRUG
Also known as: Placebo tablets
FerinjectPlacebo infusion and tablets
Placebo for ferinjectDRUG
Also known as: NaCl
Ferrous fumaratePlacebo infusion and tablets

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gynecological surgery
  • Hb 5-7 mmol/L

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Orbis Medical Centre

Sittard, Limburg, 6162 BG, Netherlands

Location

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltoseferrous fumarateIronFumarates

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Limitations and Caveats

Evident conclusions cannot be drawn from this small prematurely stopped study.

Results Point of Contact

Title
Prof. dr. Roy Kruitwagen
Organization
Maastricht University Medical Centre
r.kruitwagen@mumc.nl
0031-3874764

Study Officials

  • Roy Kruitwagen

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

November 4, 2013

Study Start

March 2, 2015

Primary Completion

May 17, 2018

Study Completion

June 21, 2018

Last Updated

August 22, 2022

Results First Posted

August 22, 2022

Record last verified: 2022-03

Locations

NL(2)