Treatment of Women After Postpartum Haemorrhage

NCT01895218 | Completed Phase 3

• 1 other identifier: PP-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  From exposure to 12 weeks post-exposure

Secondary Outcomes (13)

• Change in Hb concentration

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

• Change in concentrations of p-ferritin

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

• Change in Fatigue symptoms

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

• Change in postpartum depression symptoms

  From exposure to 12 weeks post-exposure

• Breastfeeding

  From exposure to 12 weeks post-exposure

Other Outcomes (2)

• Change in anaemia symptoms

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

• Change in gastrointestinal symptoms

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

Study Arms (2)

Iron isomaltoside 1000 (Monofer®)

EXPERIMENTAL

Drug: Iron isomaltoside 1000

Standard medical Care

ACTIVE COMPARATOR

Other: Standard medical Care

Interventions

Iron isomaltoside 1000 DRUG

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.

Also known as: Monofer®

Iron isomaltoside 1000 (Monofer®)

Standard medical Care OTHER

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

Standard medical Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead
• BioStata: collaborator

Study Sites (1)

Unknown Facility

Copenhagen, Denmark

Location

Related Publications (2)

• 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.

  PMID: 29558233 DERIVED

• 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.

  PMID: 25588587 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 10, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

DK (1)