The administration of fibrinogen concentrate (a component of blood involved in clotting process) to be given to those women who, after delivery of babies, develop severe bleeding to establish if this drug will prevent further blood loss or reduce the volume of blood loss.

Phase 3

• Conditions: Post partum haemorrhage; Reproductive Health and Childbirth - Childbirth and postnatal care; Blood - Clotting disorders

• Registration Number: ACTRN12614000691640
• Lead Sponsor: Auckland City Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 245

Inclusion Criteria

Insure both criteria 1) and 2) are satisfied;
1.Women with estimated blood loss greater than 1000mL in the immediate postpartum period (<4 hours postpartum).
2.Women with persistent PPH not responding to first line uterotonic therapy (i.e. syntocinon infusion), and manual uterine compression in whom further haemostatic intervention is being considered.

Exclusion Criteria

Exclusion criteria
1)Women with coagulopathic disorder secondary to pre-existing liver disease.
2)Women with confirmed venous thromboembolism occurring in the last 4 weeks of pregnancy
3)Women with confirmed allergy to fibrinogen concentrate
4)Woman who refuse blood products

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy<br>25% reduction in total measured blood volume loss. Blood loss is currently measured by means of collection via suction catheter to collection bags and weighing of swabs. Estimation/ measurement of amniotic fluid noted. For study we aim for the process to be as accurate as possible. We plan to use obstetric specific bags for blood loss during delivery/ collection via suction collection/ weighing of swabs . To compare volume blood loss measured we will correlate volume loss by calculating starting haemoglobin, to post bleed haemoglobin and include fluid and blood and products administered. [24 hours]

Secondary Outcome Measures

Name	Time	Method
Incidence of moderate PPH (blood loss between 1000 and 2000ml)<br>[12 months (study period)];Incidence of severe PPH (blood loss >2000 ml)[12 months (study period)];Total blood product usage [24hrs];Activation of Massive transfusion protocol. (MTP)[24 hrs];Need for haemostatic intervention (balloon tamponade, uterine artery embolization, surgical arterial ligation, hysterectomy)[24 hrs];Anaemia with Hb <80 g/L at 24 hours post delivery<br><br>(Blood test at 24hrs)<br>[24 hrs];Admission to ICU/ DCCM[6months];Maternal mortality[6 months];Infection rates (wound infection, endometritis, pneumonia)<br>(review hospital notes, clinic follow up, re-admission)[3 months];Breast feeding rates at hospital discharge and at 6 weeks<br>(Questionnaire) [6 weeks];Quality of life indicators as per WHODAS 2.0/ post-traumatic stress disorder score at 6 weeks<br>[6 weeks];Anaemia at 6 weeks postpartum (Hb <100 g/L)[Blood test at 6 weeks]