Post-Partum Haemorrhage Butterfly study (II): clinical testing and commercialisation

ISRCTN	ISRCTN15452399
DOI	https://doi.org/10.1186/ISRCTN15452399
Secondary identifying numbers	31655

Submission date: 14/08/2017
Registration date: 11/09/2017
Last edited: 13/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Postpartum hemorrhage (PPH) described when there is serious bleed right after giving birth. Some bleeding is normal after birth, but when there is a lot of blood, women need medication, blood transfusions or other serious surgical methods. The PPH (Postpartum Haemorrhage) Butterfly is a simple, low cost device which has been developed at the University of Liverpool for management of heavy bleeding immediately after childbirth (PPH). The research question is relevant to women in that if the device is successful in "turning off the tap" there will be direct tangible benefits to the women and may avoid the need for women to undergo surgical procedures in theatre for treatment.

Who can participate?
Women aged 16 and older with PPH following vaginal birth which is unresponsive to the first line management.

What does the study involve?
Participants who have PPH receive the standard treatment in line with the clinic but also have the PPH Butterfly used in an attempt to stop the bleeding. The device is used for a maximum of five times for five minutes to compress the uterus. Participants are followed up for one hour post PPH and until she leaves the hospital. Women who received the PPH Butterfly have their outcomes compared to the records of women who did not receive the PPH Butterfly to see how beneficial it is.

What are the possible benefits and risks of participating?
Participants may benefit from the device working to stop the bleeding in a short time period, saving the trauma of having an extended bleed and possible surgery. This may also have psychosocial benefits as post-partum surgery would mean that the woman is separated from her baby for a period of time which may affect bonding with her baby and establishing breast feedings. The risks to the women are minimized by receiving PPI standard treatment alongside the use of the PPH Butterfly. The device has been tested and a comprehensive education programme has been developed.

Where is the study run from?
Liverpool Women's Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2016 to March 2019

Who is funding the study?
University of Liverpool (UK)

Who is the main contact?
1. Mrs Mira Ebringer
m.ebringer@liverpool.ac.uk
2. Professor Andrew Weeks
aweeks@liverpool.ac.uk

Study website

Contact information

Mrs Mira Ebringer
Public

Sanyu Research Unit
Dept of Women's and Children's Health
University of Liverpool
1st Floor
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Phone	+44 (0)151 795 7872
Email	m.ebringer@liverpool.ac.uk

Prof Andrew Weeks
Scientific

Sanyu Research Unit
Dept of Women's and Children's Health
University of Liverpool
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Phone	+44 (0)151 795 9578
Email	aweeks@liverpool.ac.uk

Study information

Study design	Non-randomised; Interventional; Design type: Treatment, Device
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	An open label, phase II, un-randomised trial of a novel medical device to manage post-partum haemorrhage, with historical controls
Study objectives	The aim of this study is to assess the difference in clinical outcomes of women who experience PPH and who were treated under the Liverpool Women's Hospital standard clinical treatment pathway for PPH (controls) with those who are treated with the PPH Butterfly.
Ethics approval(s)	NW Liverpool Central REC, 05/07/2017, ref: 17/NW/0373
Health condition(s) or problem(s) studied	Specialty: Reproductive health and childbirth, Primary sub-specialty: General Gynaecology; UKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and delivery
Intervention	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 Liverpool Women's Hospital clinical care pathway on PPH but the PPH Butterfly is used in an attempt to "turn off the tap" and bring a halt to bleeding. The device will be used for up to a maximum of 5 iterations of 5 minutes of employing the device to achieve uterine compression. Follow-up on the woman will be for one hour post PPH and then until she leaves the Liverpool Women’s Hospital. The device has both treatment and diagnostic properties in determining where the source of the bleeding emanates from i.e. uterine or vaginal bleeding caused by intra-partum lacerations. 236 historical controls (2:1) are be used to assess the difference in clinical outcomes of women who experienced a PPH and who were treated under the Liverpool Women's Hospital standard clinical treatment pathway for PPH (controls) with those women who were treated with the PPH Butterfly.
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Additional blood loss of over 1000ml after first use of the device at 24 hours after birth
Secondary outcome measures	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.
Overall study start date	01/04/2016
Completion date	31/03/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 118; UK Sample Size: 118
Total final enrolment	57
Key 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
Key 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
Date of first enrolment	01/11/2017
Date of final enrolment	21/12/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Liverpool Women's Hospital

Crown Street
Liverpool
L8 7SS
United Kingdom

Sponsor information

University of Liverpool
Hospital/treatment centre

2nd Floor
Waterhouse Building
Brownlow Street
Liverpool
L69 3QL
England
United Kingdom

Phone	+44 151 794 8739
Email	sponsor@liverpool.ac.uk
"ROR"	https://ror.org/04xs57h96

Funders

Funder type

Government

National Institute for Health Research Central Commissioning Facility (CCF); Grant Code: II-LA-0715-20008

No information available

Results and Publications

Intention to publish date	30/04/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	It is planned for the results to be written up for publication along with the design process. All papers will be written with a view to submitting into high level health journals. A lay summary will also be prepared for the women who participated in the study – participants will be asked whether they wish to receive it at the time of recruitment.
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/01/2023	03/02/2023	Yes	No
Other publications	Economic evaluation	04/03/2023	13/03/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

13/03/2023: Publication reference added.
03/02/2023: Publication reference added.
12/01/2023: The following changes were made to the trial record:
1. Contact details updated.
2. Total final enrolment added.
3. The intention to publish date was changed from 30/04/2020 to 30/04/2023.
15/07/2022: The secondary study design has been changed from 'Randomised controlled trial' to 'Non-randomised study'.
15/01/2019: The following changes have been made:
1. The recruitment end date was changed from 31/12/2018 to 21/12/2018.
2. The funder name was changed from "National Institute for Health Research Central Commissioning Facility (CCF); Grant Codes: II-LA-0715-20008" to "National Institute for Health Research Central Commissioning Facility (CCF); Grant Code: II-LA-0715-20008".
07/11/2018: The recruitment end date was changed from 31/10/2018 to 31/12/2018.