Specialty: Reproductive health and childbirth, Primary sub-specialty: General Gynaecology
Conditions
Interventions
The intervention to be used is an innovative medical device, the PPH Butterfly, which has been designed by an NHS Consultant Obstetrician. In this trial the women are treated for PPH in line with the
Sponsors
University of Liverpool
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with PPH following vaginal birth which is unresponsive to first line management (usually intravenous or intramuscular oxytocin +/- ergometrine) 2. Aged over 16
Exclusion criteria
Exclusion criteria: 1. Women assessed antenatally to have learning difficulties that may have the potential to impair their decision making 2. Women aged < 16 years of age 3. Women who cannot read or understand the level of English used in the study documentation 4. Women whose baby is stillborn 5. Women whose PPH occurs more than 24 hours following birth 6. Women who have undergone Female Genital Mutilation/vaginal surgery which is unreversed (assessed antenatally) 7. Women with clotting disorders; either longstanding or following intrapartum events 8. Women in whom the third stage of labour is not complete (placenta remains in situ) or who had a retained placenta of over 30 minutes 9. Women who have had a caesarean section 10. Women who have fainted or who are unconscious (including those under anaesthetic) during the PPH 11. Women whose PPH is clinically diagnosed after 1 hour of baby’s birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Additional blood loss of over 1000ml after first use of the device at 24 hours after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean estimated blood loss (from time of insertion of the device until cessation of active bleeding). Overall estimates will be based on visual estimates supplemented with information from weighing of swabs and collected blood where available. 2. Use of additional interventions within 24 hours to control ongoing bleeding, and whether this was a haemostatic drug (e.g. ergometrine, carboprost, tranexamic acid), or surgical intervention (including Bakri balloon and examination under anaesthetic). 3. Any organ dysfunction as defined by the WHO Maternal ‘near-miss’ Approach (Say 2009). The WHO maternal near-miss tool is a composite measure consisting of 25 clinical, laboratory and management-based criteria (WHO 2011). Specifically relevant to haemorrhage are shock, blood transfusion, coagulopathy and hysterectomy, all of which will be reported separately as well as in this composite outcome of organ dysfunction as recommended by the COS. 4. Number of women receiving a blood transfusion (defined as ‘any blood transfusion or cell salvage of over 300mls within 48 hours of birth’) and the number of units of blood received. 5. Shock (defined as any systolic blood pressure under 100mmHg within 24 hrs of recruitment The core outcome set available via http://www.comet-initiative.org/studies/details/706 has been consulted in the construction of the study outcome measures. | — |
Countries
England, United Kingdom
Contacts
Public ContactMira Ebringer
Outcome results
None listed