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The Postpartum Haemorrhage (PPH) Butterfly Work Package 3

NCT02692287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-03-06

No results posted yet for this study

Summary

The Postpartum Haemorrhage (PPH) Butterfly is a simple, low-cost device which has been developed as a treatment method for PPH. It will be used to stop the bleeding through compression of the uterus of women having a PPH. It will be markedly easier to undertake than traditional bimanual compression, whilst also being significantly more acceptable to women themselves. Use of the PPH Butterfly will provide an alternative management option for PPH and in some cases should avoid the need for women to have to go to theatre for treatment. This research will allow the investigators to determine if they have the optimum size and shape of the device, that it will operate as intended when compressing the uterus, and to gauge its acceptability to participants and users. In phase I the investigators will recruit "healthy volunteers" i.e. women who have delivered their baby vaginally following Induction of labour (IOL) however these women will not be experiencing a PPH. The device is to be assessed purely on size, usability and acceptability not for diagnosis or as a treatment method. Following the delivery participants will be invited to have the PPH Butterfly inserted vaginally for an average of 2 minutes. It is through this that the investigators will assess the suitability of the device in its current design, when it is in practice. The clinician who operates the device will complete a Likert scale questionnaire along with some open questions following each administration. Participants will also answer a short questionnaire. .

Conditions

  • Postpartum Haemorrhage (PPH)

Interventions

DEVICE

The PPH Butterfly

The PPH Butterfly is a simple, low cost device that has been developed to facilitate less invasive compression of the uterus in a PPH

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Liverpool Women's NHS Foundation Trust

    collaborator OTHER

  • Andrew Weeks MD MRCOG

    lead OTHER

Principal Investigators

  • Andrew Weeks · University of Liverpool

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-03-01
Completion
2017-04-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02692287 on ClinicalTrials.gov