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Treatment of Women After Postpartum Haemorrhage (PP-01)

Primary Purpose

Postpartum Haemorrhage

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Iron isomaltoside 1000

Standard medical Care

About this trial

This is an interventional treatment trial for Postpartum Haemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women with PPH ≥ 700 and ≤ 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery
Willingness to participate and signed the informed consent form

Exclusion Criteria:

Women aged < 18 years
Multiple births
Peripartum RBC transfusion
Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
Women with a history of active asthma within the last 5 years or a history of multiple allergies
Known decompensated liver cirrhosis and active hepatitis
Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
Active acute infection assessed by clinical judgement
Rheumatoid arthritis with symptoms or signs of active joint inflammation
History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
Not able to read, speak and understand the Danish language
Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
Any other medical condition that, in the opinion of the Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iron isomaltoside 1000 (Monofer®)

Standard medical Care

Arm Description

Outcomes

Primary Outcome Measures

Physical fatigue

The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.

Secondary Outcome Measures

Change in Hb concentration

Change in concentrations of p-ferritin

Change in Fatigue symptoms

Change in postpartum depression symptoms

Breastfeeding

RCB transfusions

Adverse drug reactions (ADRs)

Change in concentrations of p-iron

Change in concentrations of p-transferrin

Change in concentrations of transferrin saturation (TSAT)

Change in concentrations of reticulocyte count

Change in concentrations of mean reticulocyte haemoglobin content (CHr)

Change in haematology parameters

Full Information

NCT ID

NCT01895218

First Posted

June 26, 2013

Last Updated

April 28, 2015

Sponsor

Pharmacosmos A/S

Collaborators

BioStata

1. Study Identification

Unique Protocol Identification Number

NCT01895218

Brief Title

Treatment of Women After Postpartum Haemorrhage

Acronym

PP-01

Official Title

A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Standard Medical Care in Women After Postpartum Haemorrhage

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmacosmos A/S

Collaborators

BioStata

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.

6. Conditions and Keywords

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

Postpartum Haemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iron isomaltoside 1000 (Monofer®)

Arm Type

Experimental

Arm Title

Standard medical Care

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Iron isomaltoside 1000

Other Intervention Name(s)

Monofer®

Intervention Description

A single dose of 1200 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9 % sodium chloride and given over approximately 15 min.

Intervention Type

Other

Intervention Name(s)

Standard medical Care

Intervention Description

Standard medical Care is most often to recommend women with PPH to continue oral iron supplementation as recommended during pregnancy or to advise the subject to take 100 mg oral iron 1-2 times a day

Primary Outcome Measure Information:

Title

Physical fatigue

Description

The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.

Time Frame

From exposure to 12 weeks post-exposure

Secondary Outcome Measure Information:

Title

Change in Hb concentration

Time Frame

From exposure to week 1, 3, 8 and 12 post-exposure

Title

Change in concentrations of p-ferritin

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in Fatigue symptoms

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in postpartum depression symptoms

Time Frame

From exposure to 12 weeks post-exposure

Title

Breastfeeding

Time Frame

From exposure to 12 weeks post-exposure

Title

RCB transfusions

Time Frame

From exposure to 12 weeks post-exposure

Title

Adverse drug reactions (ADRs)

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in concentrations of p-iron

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in concentrations of p-transferrin

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in concentrations of transferrin saturation (TSAT)

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in concentrations of reticulocyte count

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in concentrations of mean reticulocyte haemoglobin content (CHr)

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in haematology parameters

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Other Pre-specified Outcome Measures:

Title

Change in anaemia symptoms

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

Title

Change in gastrointestinal symptoms

Time Frame

From exposure to day 3, week 1, 3, 8 and 12 post-exposure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women with PPH ≥ 700 and ≤ 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery Willingness to participate and signed the informed consent form Exclusion Criteria: Women aged < 18 years Multiple births Peripartum RBC transfusion Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) Known hypersensitivity to parenteral iron or any excipients in the investigational drug products Women with a history of active asthma within the last 5 years or a history of multiple allergies Known decompensated liver cirrhosis and active hepatitis Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines") Active acute infection assessed by clinical judgement Rheumatoid arthritis with symptoms or signs of active joint inflammation History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) Not able to read, speak and understand the Danish language Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline Any other medical condition that, in the opinion of the Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus

Facility Information:

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

29558233

Citation

Holm C, Thomsen LL, Langhoff-Roos J. Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage. J Matern Fetal Neonatal Med. 2019 Sep;32(17):2797-2804. doi: 10.1080/14767058.2018.1449205. Epub 2018 Mar 20.

Results Reference

derived

PubMed Identifier

25588587

Citation

Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2015 Jan 14;16:5. doi: 10.1186/1745-6215-16-5.

Results Reference

derived

Learn more about this trial

Treatment of Women After Postpartum Haemorrhage

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