Fibrinogen concentrate to treat postpartum haemorrhage

• Research type

  Research Study

• Full title

  Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage: a prospective double blind randomised control trial

• IRAS ID

  108633

• Contact name

  Peter Collins

• Sponsor organisation

  RACD Cardiff University

• Eudract number

  2012-005511-11

• Research summary

  Bleeding at the time of childbirth is major cause of maternal morbidity. Bleeding is caused by a combination of physical causes, such as failure of the uterus to contract or operations, and is made worse by impairment of the 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 invasive procedures and the need for blood transfusion. This study will investigate whether replacing fibrinogen early during bleeding at the time of childbirth reduces the total number of units of blood and blood components women need to be transfused.Women who are bleeding after childbirth (1500 mL without any complication or 1000 mL with a complication) will be included within the observational phase of this study (1050 women in total). Women (60 in total) who go on to have a low fibrinogen (measured by a point of care test called the Fibtem) will have an equal chance of being treated (randomised) either with an infusion of fibrinogen concentrate or a dummy infusion. Apart from this all women (both in the randomised and observational phase) will receive standard care. Women in the randomised phase will be contacted at 6 weeks via telephone to complete a questionnaire. The study will recruit from three centres: Cardiff and Vale University Health Board, Leicester Royal Infirmary and University College Hospital London.

• REC name

  Scotland A REC

• REC reference

  13/SS/0008

• Date of REC Opinion

  12 Mar 2013

• REC opinion

  Further Information Favourable Opinion