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

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01975272
• Collaborator: Vifor Pharma (Industry)
• Enrollment: 27
• Locations: 2
• Arms: 3
• Actual Duration (Months): 39.7
• Patients Per Site: 13.5
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Anaemia	Drug: Ferinject; Drug: Ferrous fumarate; Drug: Placebo for ferrous fumarate; Drug: Placebo for ferinject	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial
• Actual Study Start Date: Mar 2, 2015
• Actual Primary Completion Date: May 17, 2018
• Actual Study Completion Date: Jun 21, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hemoglobin [3 weeks postoperative]

   Serum hemoglobin level

Secondary Outcome Measures

1. Serum Ferritin [3 weeks postoperative]

   Serum levels of ferritin

2. Serum Hepcidin [3 weeks postoperative]

   Serum hepcidin level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Centre	Maastricht	Limburg	Netherlands	6202 AZ
2	Orbis Medical Centre	Sittard	Limburg	Netherlands	6162 BG

Sponsors and Collaborators

• Maastricht University Medical Center
• Vifor Pharma

Investigators

• Principal Investigator: Roy Kruitwagen, Maastricht University Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 9, 2016

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT01975272
• Other Study ID Numbers: METC 12-2-018
• First Posted: Nov 3, 2013
• Last Update Posted: Aug 22, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Maastricht University Medical Center: postoperative; anemia; gynaecologic; surgery
• Additional relevant MeSH terms: Anemia; Iron; Ferrous fumarate; Ferric Compounds

Study Results

Participant Flow

Arm/Group Title	Ferinject	Ferrous Fumarate	Placebo Infusion and Tablets
Arm/Group Description	Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate	2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject	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 Placebo for ferrous fumarate Placebo for ferinject
Period Title: Overall Study
STARTED	9	10	8
COMPLETED	8	9	6
NOT COMPLETED	1	1	2

Baseline Characteristics

Arm/Group Title	Ferinject	Ferrous Fumarate	Placebo Infusion and Tablets	Total
Arm/Group Description	Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate	2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject	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 Placebo for ferrous fumarate Placebo for ferinject	Total of all reporting groups
Overall Participants	8	9	6	23
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	8 100%	9 100%	6 100%	23 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	8 100%	9 100%	6 100%	23 100%
Male	0 0%	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Netherlands	8 100%	9 100%	6 100%	23 100%

Outcome Measures

1. Primary Outcome

Title	Hemoglobin
Description	Serum hemoglobin level
Time Frame	3 weeks postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ferinject	Ferrous Fumarate	Placebo Infusion and Tablets
Arm/Group Description	Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate	2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject	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 Placebo for ferrous fumarate Placebo for ferinject
Measure Participants	6	5	4
Mean (Full Range) [mmol/L]	8.4	7.9	7.1

2. Secondary Outcome

Title	Serum Ferritin
Description	Serum levels of ferritin
Time Frame	3 weeks postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ferinject	Ferrous Fumarate	Placebo Infusion and Tablets
Arm/Group Description	Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate	2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject	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 Placebo for ferrous fumarate Placebo for ferinject
Measure Participants	6	5	4
Mean (Full Range) [microgram/L]	422	57	37

3. Secondary Outcome

Title	Serum Hepcidin
Description	Serum hepcidin level
Time Frame	3 weeks postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ferinject	Ferrous Fumarate	Placebo Infusion and Tablets
Arm/Group Description	Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate	2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject	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 Placebo for ferrous fumarate Placebo for ferinject
Measure Participants	6	5	4
Mean (Full Range) [nmol/L]	11.6	2.2	1.7

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Ferinject		Ferrous Fumarate		Placebo Infusion and Tablets
Arm/Group Description	Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate		2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject		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 Placebo for ferrous fumarate Placebo for ferinject
All Cause Mortality
	Ferinject		Ferrous Fumarate		Placebo Infusion and Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)		0/8 (0%)
Serious Adverse Events
	Ferinject		Ferrous Fumarate		Placebo Infusion and Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Ferinject		Ferrous Fumarate		Placebo Infusion and Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)		0/8 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.