Fibrinogen concentrate to treat bleeding at the time of childbirth

Phase 1

• Conditions: Postpartum haemorrhage; MedDRA version: 14.1 Level: LLT Classification code 10043454 Term: Third-stage postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 14.1 Level: LLT Classification code 10036294 Term: Postpartum haemorrhage (primary) System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 14.1 Level: PT Classification code 10036417 Term: Postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]; MedDRA version: 14.1 Level: PT Classification code 10043449 Term: Third stage postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

• Registration Number: EUCTR2012-005511-11-GB
• Lead Sponsor: RACD Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-15
• Study Completion: 2015-11-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 57

Inclusion Criteria

Inclusion criteria 1) Women Age 18 years or over 2) Women should have any one of the following within the first 12 hours after delivery: a) Haemorrhage of about 1500 mL and ongoing bleeding without another complication or b) Haemorrhage of about 1000 mL and ongoing bleeding with any of: i. caesarean section ii. uterine atony iii. placental abruption iv. placenta praevia v. Cardiovascular instability (arterial blood pressure below 90mm/Hg and heart rate greater than 100 bpm) vi. Clinical observation of microvascular oozing NB. Women can be included if they fulfill the inclusion criteria after delivery of the baby but where the bleeding had started in the antenatal period (antepartum haemorrhage). Women can be included where there is a slow accumulation of on-going blood loss (in the first 12 hours after delivery) if they fulfill the inclusion criteria. Participants will be eligible for randomisation and entry into the interventional phase of the study if there are both • On-going bleeding and • FIBTEM MCF < 18mm
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1050
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion criteria The following groups will be excluded: 1) Women who have stated that they do not want to participate in the study during the antenatal period 2) Women declining infusion of red blood cells or blood components 3) Known inherited bleeding disorder 4) Placenta accreta diagnosed antenatally 5) Women who have already received uterine brace sutures, uterine tamponade balloons, radiology intervention or hysterectomy before entering the study 6) Clinical suspicion of amniotic fluid embolism 7) Secondary postpartum haemorrhage (haemorrhage which starts >12 hours after delivery)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified