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OBS2

Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage - a multicentre, prospective, double blind randomised control trial.

Background

Bleeding at the time of childbirth (postpartum haemorrhage, PPH) is a major cause of death. Bleeding is caused when the uterus fails to contract or by operations. This is made worse by damage of blood clotting system. A number of studies have shown that low levels of a blood clotting factor called fibrinogen is associated with worse bleeding, the need for surgical measures and the need for blood transfusion. This study will investigate whether infusion of fibrinogen concentrate, based on the FIBTEM A5 test, during a moderately severe PPH reduces the total number of allogeneic blood products transfused after study medication until discharge compared to placebo.

Study design

Women experiencing major postpartum haemorrhage (PPH) participated in this study.

Participating women were randomly allocated to one of two groups. One group received fibrinogen concentrate injected into the vein and the other group received a placebo (dummy). All participants were contacted via telephone after 6 weeks by a midwife.

Possible benefits and risks of fibrinogen

We hope that giving fibrinogen will reduce blood loss, so there may be a benefit to the participant from taking part in this study. We also hope that the results may help to improve the treatment of women who experience similar blood loss at the time of childbirth in the future.

Fibrinogen is not a new treatment and it has been used in patients who have low levels of fibrinogen for many years, but its use in bleeding at the time of childbirth is relatively new. There is no evidence to suggest that fibrinogen has any serious side effects when used during childbirth but, because it is not routinely used at this time, we may not know all the possible side effects. The idea of giving women fibrinogen is to thicken the blood to stop bleeding but it is possible that this may cause clots where they are not needed and we will be especially vigilant for this.

Study sites across the UK

The study was run from four centres in the UK: Cardiff and Vale University Health Board, Leicester Royal Infirmary, University College Hospital London and Liverpool Women’s Hospital NHS Foundation Trust.

Study duration

Recruitment started in June 2013 and ended in December 2014. Participating women were followed up for 6 weeks. Results are due to be published in 2017.

Information

Chief Investigator(s)
Funder(s) CSL Behring
Sponsor Cardiff University

Key facts

Start date 1 Oct 2012
End date 30 Dec 2014
Grant value £718,871
Status
  • Analysis and reporting

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