A mixed method, phase 2 clinical evaluation of a novel device to treat
postpartum haemorrhage

Andrew D. Weeks; Caroline Cunningham; Wendy Taylor; Anna Rosala-Hallas; Peter Watt; Lucy Bryning; Victory Ezeofor; Liz Cregan; Emma Hayden; Dot Lambert; Carol Bedwell; Steven Lane; Tony Fisher; Rhiannon T. Edwards; Tina Lavender

doi:10.1016/j.ejogrb.2023.01.018

A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage

Andrew D. Weeks, Caroline Cunningham, Wendy Taylor, Anna Rosala-Hallas, Peter Watt, Lucy Bryning, Victory Ezeofor, Liz Cregan, Emma Hayden, Dot Lambert, Carol Bedwell, Steven Lane, Tony Fisher, Rhiannon T. Edwards, Tina Lavender

International Public Health

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

Background:

We evaluated the safety, efficacy, and acceptability of a new device designed to facilitate uterine compression in women with postpartum haemorrhage (PPH).

Methods:

A prospective, phase two clinical device trial with concurrent qualitative study, conducted in a UK consultant obstetric unit. The device was used in addition to standard care in women unresponsive to initial oxytocin therapy. The primary effectiveness outcome was additional blood loss of over 1000mls, whilst safety was assessed through adverse events. Interviews assessed device feasibility and acceptability, and were analysed using framework analysis.

Results:

We recruited 57 women with clinical PPH after vaginal birth; 67% were primiparous and 47% had undergone operative birth. All but two (96%) had atony as a cause of the haemorrhage; in addition, 30% also had bleeding from lacerations and 11% had retained tissue. After device use, only one woman had additional blood loss over 1000mls, although 3 women (7%) needed a Bakri balloon and 14% received a blood transfusion. All but one clinician felt that the device was easy to use. Clinicians stated that the device assisted management in 85% of cases. All 56 women who responded stated that if they bled in a future birth they would want the device to be used again. There were no serious adverse events related to the device. However, 3 events were judged as 'possibly' being caused by the device - 2 minor vaginal grazes and one postnatal episiotomy infection and breakdown. Lax vaginal tissue complicated the use of the device in three women. In 47 interviews, participants, birth partners, clinician users and attending midwives viewed the device positively. Clinicians found it useful as a way of stopping blood loss and as an aid to diagnose the source of bleeding.

Conclusions:

The PPH Butterfly may provide a rapid, acceptable and effective treatment for postpartum haemorrhage.

Original language	English
Pages (from-to)	142-148
Number of pages	7
Journal	European Journal of Obstetrics and Gynecology and Reproductive Biology
Volume	283
Early online date	21 Jan 2023
DOIs	https://doi.org/10.1016/j.ejogrb.2023.01.018
Publication status	E-pub ahead of print - 21 Jan 2023

Keywords

Bimanual compression
Birth
Labour and delivery
Medical device
Postpartum haemorrhage
Third stage of labour

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Weeks PPH main paperFinal published version, 1.91 MBLicence: CC BY

Cite this

Weeks, A. D., Cunningham, C., Taylor, W., Rosala-Hallas, A., Watt, P., Bryning, L., Ezeofor, V., Cregan, L., Hayden, E., Lambert, D., Bedwell, C., Lane, S., Fisher, T., Edwards, R. T., & Lavender, T. (2023). A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage. European Journal of Obstetrics and Gynecology and Reproductive Biology, 283, 142-148. Advance online publication. https://doi.org/10.1016/j.ejogrb.2023.01.018

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title = "A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage",

abstract = "Background: We evaluated the safety, efficacy, and acceptability of a new device designed to facilitate uterine compression in women with postpartum haemorrhage (PPH).Methods: A prospective, phase two clinical device trial with concurrent qualitative study, conducted in a UK consultant obstetric unit. The device was used in addition to standard care in women unresponsive to initial oxytocin therapy. The primary effectiveness outcome was additional blood loss of over 1000mls, whilst safety was assessed through adverse events. Interviews assessed device feasibility and acceptability, and were analysed using framework analysis.Results: We recruited 57 women with clinical PPH after vaginal birth; 67\% were primiparous and 47\% had undergone operative birth. All but two (96\%) had atony as a cause of the haemorrhage; in addition, 30\% also had bleeding from lacerations and 11\% had retained tissue. After device use, only one woman had additional blood loss over 1000mls, although 3 women (7\%) needed a Bakri balloon and 14\% received a blood transfusion. All but one clinician felt that the device was easy to use. Clinicians stated that the device assisted management in 85\% of cases. All 56 women who responded stated that if they bled in a future birth they would want the device to be used again. There were no serious adverse events related to the device. However, 3 events were judged as 'possibly' being caused by the device - 2 minor vaginal grazes and one postnatal episiotomy infection and breakdown. Lax vaginal tissue complicated the use of the device in three women. In 47 interviews, participants, birth partners, clinician users and attending midwives viewed the device positively. Clinicians found it useful as a way of stopping blood loss and as an aid to diagnose the source of bleeding.Conclusions: The PPH Butterfly may provide a rapid, acceptable and effective treatment for postpartum haemorrhage.",

keywords = "Bimanual compression, Birth, Labour and delivery, Medical device, Postpartum haemorrhage, Third stage of labour",

author = "Weeks, \{Andrew D.\} and Caroline Cunningham and Wendy Taylor and Anna Rosala-Hallas and Peter Watt and Lucy Bryning and Victory Ezeofor and Liz Cregan and Emma Hayden and Dot Lambert and Carol Bedwell and Steven Lane and Tony Fisher and Edwards, \{Rhiannon T.\} and Tina Lavender",

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Weeks, AD, Cunningham, C, Taylor, W, Rosala-Hallas, A, Watt, P, Bryning, L, Ezeofor, V, Cregan, L, Hayden, E, Lambert, D, Bedwell, C, Lane, S, Fisher, T, Edwards, RT & Lavender, T 2023, 'A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage', European Journal of Obstetrics and Gynecology and Reproductive Biology, vol. 283, pp. 142-148. https://doi.org/10.1016/j.ejogrb.2023.01.018

TY - JOUR

T1 - A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage

AU - Weeks, Andrew D.

AU - Cunningham, Caroline

AU - Taylor, Wendy

AU - Rosala-Hallas, Anna

AU - Watt, Peter

AU - Bryning, Lucy

AU - Ezeofor, Victory

AU - Cregan, Liz

AU - Hayden, Emma

AU - Lambert, Dot

AU - Bedwell, Carol

AU - Lane, Steven

AU - Fisher, Tony

AU - Edwards, Rhiannon T.

AU - Lavender, Tina

PY - 2023/1/21

Y1 - 2023/1/21

N2 - Background: We evaluated the safety, efficacy, and acceptability of a new device designed to facilitate uterine compression in women with postpartum haemorrhage (PPH).Methods: A prospective, phase two clinical device trial with concurrent qualitative study, conducted in a UK consultant obstetric unit. The device was used in addition to standard care in women unresponsive to initial oxytocin therapy. The primary effectiveness outcome was additional blood loss of over 1000mls, whilst safety was assessed through adverse events. Interviews assessed device feasibility and acceptability, and were analysed using framework analysis.Results: We recruited 57 women with clinical PPH after vaginal birth; 67% were primiparous and 47% had undergone operative birth. All but two (96%) had atony as a cause of the haemorrhage; in addition, 30% also had bleeding from lacerations and 11% had retained tissue. After device use, only one woman had additional blood loss over 1000mls, although 3 women (7%) needed a Bakri balloon and 14% received a blood transfusion. All but one clinician felt that the device was easy to use. Clinicians stated that the device assisted management in 85% of cases. All 56 women who responded stated that if they bled in a future birth they would want the device to be used again. There were no serious adverse events related to the device. However, 3 events were judged as 'possibly' being caused by the device - 2 minor vaginal grazes and one postnatal episiotomy infection and breakdown. Lax vaginal tissue complicated the use of the device in three women. In 47 interviews, participants, birth partners, clinician users and attending midwives viewed the device positively. Clinicians found it useful as a way of stopping blood loss and as an aid to diagnose the source of bleeding.Conclusions: The PPH Butterfly may provide a rapid, acceptable and effective treatment for postpartum haemorrhage.

AB - Background: We evaluated the safety, efficacy, and acceptability of a new device designed to facilitate uterine compression in women with postpartum haemorrhage (PPH).Methods: A prospective, phase two clinical device trial with concurrent qualitative study, conducted in a UK consultant obstetric unit. The device was used in addition to standard care in women unresponsive to initial oxytocin therapy. The primary effectiveness outcome was additional blood loss of over 1000mls, whilst safety was assessed through adverse events. Interviews assessed device feasibility and acceptability, and were analysed using framework analysis.Results: We recruited 57 women with clinical PPH after vaginal birth; 67% were primiparous and 47% had undergone operative birth. All but two (96%) had atony as a cause of the haemorrhage; in addition, 30% also had bleeding from lacerations and 11% had retained tissue. After device use, only one woman had additional blood loss over 1000mls, although 3 women (7%) needed a Bakri balloon and 14% received a blood transfusion. All but one clinician felt that the device was easy to use. Clinicians stated that the device assisted management in 85% of cases. All 56 women who responded stated that if they bled in a future birth they would want the device to be used again. There were no serious adverse events related to the device. However, 3 events were judged as 'possibly' being caused by the device - 2 minor vaginal grazes and one postnatal episiotomy infection and breakdown. Lax vaginal tissue complicated the use of the device in three women. In 47 interviews, participants, birth partners, clinician users and attending midwives viewed the device positively. Clinicians found it useful as a way of stopping blood loss and as an aid to diagnose the source of bleeding.Conclusions: The PPH Butterfly may provide a rapid, acceptable and effective treatment for postpartum haemorrhage.

KW - Bimanual compression

KW - Birth

KW - Labour and delivery

KW - Medical device

KW - Postpartum haemorrhage

KW - Third stage of labour

U2 - 10.1016/j.ejogrb.2023.01.018

DO - 10.1016/j.ejogrb.2023.01.018

M3 - Article

SN - 0301-2115

VL - 283

SP - 142

EP - 148

JO - European Journal of Obstetrics and Gynecology and Reproductive Biology

JF - European Journal of Obstetrics and Gynecology and Reproductive Biology

ER -

A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage

Abstract

Keywords

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