Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage: Obstetrics Bleeding Study 2

Not Applicable

Completed

• Conditions: Reproductive Health & Childbirth; Pregnancy and Childbirth; Postpartum haemorrhage

• Registration Number: ISRCTN46295339
• Lead Sponsor: Cardiff University (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25906770 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28969328 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28969312

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-01
• Study Completion: 2015-11-26
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1050

Inclusion Criteria

1. Age 18 years or over
2. Women should have any one of the following within the first 12 hours after delivery:
2.1. Haemorrhage of about 1500 ml and ongoing bleeding without another complication
2.2. Haemorrhage of about 1000 mL and ongoing bleeding with any of:
2.2.1. caesarean section
2.2.2. uterine atony
2.2.3. placental abruption*
2.2.4. placenta praevia
2.2.5. Cardiovascular instability (arterial blood pressure below 90 mm/Hg and heart rate greater than 100 bpm)
2.2.6. Clinical observation of microvascular oozing
* If in the event of a placental abruption, women may be recruited if there is less than
1000ml visible blood loss, because bleeding at the time of abruption maybe concealed.
3. Women can be included if they fulfil the inclusion criteria after delivery of the baby but
where the bleeding had started in the antenatal period (antepartum haemorrhage)
4. Women can be included where there is a slow accumulation of on-going blood loss (in the
first 12 hours after delivery) if they fulfil the inclusion criteria

Exclusion Criteria

1. Women who have documented 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total number of allogeneic blood products (red blood cells + fresh frozen plasma (FFP) + cryoprecipitate + platelets) transfused after study medication until discharge, compared to placebo.